Rep. Joe Barton

The FDA has previously claimed the raw heparin originated from a manufacturing company in China and was purposefully contaminated with a man-made chemical, over-sulfated chondroitin sulfate, OSCS. The Chinese government disagrees.

Barton, a ranking member of the House Energy and Commerce Committee, has long championed the effort to resolve the heparin scandal by scrutinizing the FDA’s investigation into the case and the subsequent recall. He has previously argued that the agency misrepresented deaths tied to the heparin and didn’t thoroughly investigate the matter. He also has demanded answers on why the FDA took six months to seize lots of the contaminated heparin from an Ohio agency that still had the tainted drug in stock.

In his latest inquiry, Barton wants to know if the FDA has tracked the contamination back to the source. He also asked what action the Chinese government has taken in the matter and whether anyone in China has been held accountable.

Products imported from China have been in the spotlight in recent years as reports of more tainted foods, drugs and toys have entered the U.S. and injured people. The FDA has been working to expand its inspections of foreign imports in part by opening offices overseas. The first of these offices opened late last year in China.

SOURCE: Heparin Recall › Congressman demands answers on tainted heparin scandal

Letters sent by the FDA to Qingdao Jiulong Biopharmaceuticals Co. Ltd. and Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd., says that during inspection of the plants in 2008, the agency “uncovered untrue statements and information by your firm to the agency.”

In late 2007 the FDA began receiving reports of patients experiencing severe reactions after receiving injections of the blood thinner heparin. An investigation found that batches of heparin manufactured in China had been contaminated with oversulfated chondroitin sulfate (OSCS), a material that is difficult to immediately identify as it mimics heparin. The tainted blood thinner killed more than 80 Americans and sickened hundreds more before batches of the medication were recalled.

In the letters to the Chinese drug suppliers, the FDA said that although some shipments of heparin were quarantined, the drug companies did allow 19 lots to be shipped to the U.S. The agency warned that it can refuse to grant new drug applications or allow shipments to unload.

The FDA, which later admitted it did not have sufficient resources to fully inspect foreign food and drug manufacturers, has come under fire for its handling of the contaminated heparin scandal. As a result, the FDA has stepped up its efforts by opening inspection offices in foreign countries to oversee the quality of goods imported into the U.S. The first offices were placed in China with plans to have four permanent inspectors in China by mid summer.

SOURCE: Heparin Recall › FDA accuses Chinese companies of lying about role in heparin scandal

It wasn’t until then that Martin learned the syringe he had used on his young son was part of a recalled batch that was found to have been contaminated at the manufacturing plant AM2PAT. The tainted syringes killed five people and sickened at least 100 more before the Angier plant was closed. The company’s “clean room” was found to be a frightful mess.

Last month, two AM2PAT managers pleaded guilty to federal fraud and a warrant is out for AM2PAT president Dushyant Patel, who is still at large.

Knowledge of the recall did little to put Martin’s mind at ease. He wants answers from the company, the distributor of the syringes, and the Food and Drug Administration (FDA).

“I just felt, why? Why didn’t somebody stop this?” he told media. “Not only did they hand me a loaded gun, they enabled me to pull the trigger on my own son.”

An FDA warning letter to the plant in 2005 reported no major safety violations. However, an FDA spokesperson says in August 2007 the company began producing the syringes at a “dramatic rate” and that was when quality began to slip.

The FDA was notified by the Centers for Disease Control and Prevention about the adverse events reported, and within five days the FDA had closed down the plant for manufacturing violations. The FDA also contends that “evidence of a casual link between the AM2PAT product” and the infections was “never conclusively established.”

The FDA’s claims don’t sit well with Martin, who says he will pursue legal action.

Source: WRAL

SOURCE: Heparin Recall › Father blames FDA for not taking precautions to protect son

Last March, after more than 100 people died and hundreds more were sickened after being given the tainted heparin, an investigation found that heparin manufactured in Baxter’s China plant had been contaminated with oversulfated chondroitin sulfate (OSCS). OSCS mimics heparin and can cost substantially less to produce – $9 compared to $900. However, OSCS can cause serious allergic reactions which can lead to death.

The lawsuit states, “The recalled heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses. Baxter placed tens of thousands of patients, including the Plaintiffs, at unnecessary risk of serious injury and/or death.”

It also claims Baxter wrongfully allowed the heparin to be placed on the market and “breached its express warranties that heparin had no dangerous side effects and that its ingredients were manufactured in a plant in accordance with FDA regulations,” according to the report.

The six-count suit seeks a judgment of more than $300,000 plus costs and other relief.

SOURCE: Heparin Recall › Class action lawsuit filed against Baxter over tainted heparin scandal

Earlier this week two former workers at the plant, plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma, were sentenced in federal court to more than four years in prison for allowing the tainted drugs into hospitals and clinics in Colorado, Florida, Illinois and Texas. Last week, the company’s chief executive, Dushyant Patel, was indicted on 10 charges for fraud and selling adulterated medical devices. A warrant is out for his arrest.

The drugs were not produced at the plant, but were put into the syringes and shipped to the hospitals and clinics from there. According to Patel, the company recalled the syringes a year ago after federal officials began investigating the outbreak.

“Citizens in this country trust that producers of medical devices aren’t lying when they say that have adequately tested a given product,” said U.S. Attorney George Holding to the Associated Press. “As we’ve seen in this case, such lies can literally mean the difference between life and death.”

SOURCE: Heparin Recall › Two sentenced for role in tainted heparin, saline syringes

Ralph Sell of Lincoln, Nebraska, says that his wife Alice was undergoing cancer treatments in December 2007 when a syringe contaminated with Serratia marcescens, a bacteria that can cause serious injury or death, was used on her. She suffered high blood pressure, disorientation and sepsis. She died a year later at the age of 82 of “acute respiratory failure.” It has not yet been determined if the contaminated syringe may have led to her death.

Sell filed suit against Baxter International as well as its subsidiary Baxter Healthcare Corp., B. Braun Medical Inc., and AM2 PAT Inc, also known as Sierra Prefilled. A spokesperson for Baxter says the company has no role in the lawsuit, as it does not sell prefilled saline syringes. AM2 PAT did recall saline prefilled syringes in December 2007 and January 2008 because some of the syringes were tainted with the bacteria.

Baxter currently faces numerous lawsuits stemming from a 2008 recall of the blood thinner heparin. Batches of the company’s heparin manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate (OSCS). The tainted heparin is believed to have contributed to the deaths of more than 80 Americans and caused serious illnesses in hundreds more.

Sell’s lawsuit against the companies seeks unspecified damages and payment for medical costs.

SOURCE: Heparin Recall › Baxter named in contaminated saline syringe lawsuit

American Capital purchased 87 percent of Scientific Protein Laboratories in 2006. Scientific Protein Laboratories has a fair market value of $186.5 million. Last year, the parent company sought coverage from its insurers for lawsuits related to Scientific Protein Laboratories’ involvement in the tainted heparin scandal.

While Baxter International is at the center of the tainted heparin controversy, the Charter Oak Fire Insurance Co. and Travelers Property Casualty Co. of America argue that in its application for coverage, Scientific Protein Laboratories’ parent company American Capital claimed it had no subsidiaries and never mentioned Scientific Protein Laboratories or its China-based heparin venture, according to the report. In its lawsuit filed last week, the insurance companies claim that “American Capital provided false answers to Charter Oak and Travelers regarding the non-existence of subsidiaries.”

The lawsuit also claims that American Capital and Scientific Protein Laboratories entered into an agreement with Baxter International that included making payments to Baxter and giving “rights to insurance proceeds and benefits,” according to the report.

SOURCE: Heparin Recall › Heparin producer’s insurers file lawsuit

The program is designed to assist the FDA in its efforts to “prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and may not be compliant,” according to the FDA press release.

“This initiative creates incentives for drug makers to develop and maintain secure supply chains,” said Deborah Autor, Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in the press release. “This is one of several agency initiatives to enhance drug product safety.”

The pilot program compliments the agency’s recent placement of offices in foreign countries to oversee quality control standards of foods and drugs imported into the U.S. The efforts likely stem from scrutiny the agency received last year after batches of heparin produced in China were found to have been contaminated. The tainted heparin killed more than 80 people and sickened hundreds more before an investigation revealed that the heparin was most likely contaminated during manufacturing at Baxter International’s China plant. The finding led to an FDA recall of specific lots of heparin.

In the months following the heparin scandal, the FDA has come under fire from lawmakers and advocacy groups for not adequately inspecting foreign food and drug manufacturing plants, and for mishandling the contaminated heparin investigation.

SOURCE: Heparin Recall › FDA launches pilot project to oversee foreign drug products

The Quaids also sued Baxter Healthcare Corp. over the packaging and labeling of its high-dose and low-dose heparins, arguing the two bottles are easily confused. Other cases of heparin overdose have been reported and linked in part to the confusing packaging. The Quaid’s lawsuit against Baxter was dismissed on jurisdictional grounds because the event occurred in California.

Baxter was no stranger to the spotlight in 2008, facing numerous lawsuits most notably for the tainted heparin scandal earlier in the year. More than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter China plant. An investigation found that lots made in that plant were contaminated with over-sulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death. The FDA issued a recall on batches of Baxter’s heparin.

According to news reports, the Quaid-Cedars-Siani case indicates that Baxter may also sue Cedars-Siani for improperly administering the blood thinner to several patients at the hospital, including the Quaid’s newborn twins.

SOURCE: Heparin Recall › Quaid-Cedars-Siani lawsuit over heparin overdose finally closed

Joyce Ann Osteen filed the suit in St. Clair County, Illinois, and claims Baxer purposefully added a contaminant, over-sulfated chondroitin sulfate, or OSCS, to heparin manufactured in its China plant. The tainted heparin was distributed to the U.S., where hundreds of allergic reactions occurred. More than 80 people died and hundreds more were sickened by the tainted heparin before an investigation led to a recall of batches of heparin manufactured at Baxter’s China facility. The FDA later issued an announcement saying that the contaminant was an inexpensive and unapproved ingredient that mimics heparin.

OSCS costs only $9 to produce compared to $900 for heparin, the suit contends.

“The recalled heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses,” the suit states. “Baxter placed tens of thousands of patients, including the Plaintiff at unnecessarily risk of serious injury and/or death.”

The suit states Osteen and the class members who purchased the heparin “suffered actual damages as a proximate result of Baxter Healthcare Corp.’s deception in that they were deprived of the benefit of their bargain.” According to the complaint, Osteen is asking the court to certify the complaint as class action. She also is seeking damages of less than $74,999 per plaintiff or class member.

SOURCE: Heparin Recall › Class action lawsuit filed against heparin manufacturer Baxter

Early in 2008, more than 80 Americans died and hundreds more were sickened after receiving injections of heparin. An investigation found that batches of heparin manufactured in Baxter International’s China facility had been tainted with a contaminant that caused severe allergic reactions in patients who received the doses. As a result, lots of heparin manufactured by Baxter International were recalled.

The Chicago Tribune story says both the FDA and Baxter International believe the heparin was “intentionally adulterated by suppliers in China.”

The tainted heparin scandal beat out other big local news stories in the Chicago Tribune’s top 10 list, including the Tribune Co.’s filing for Chapter 11 bankruptcy protection; the city reaching the final phase of competition to host the 2016 Summer Olympics; and the selling of Wm. Wrigley Jr. Co. to Mars Inc., creating the world’s largest confectionary company.

The concern over imported foods and drugs landed heparin on U.S. News & World Report’s list of top health stories. Titled, “Dubious Drugs, Tainted Foods Top 2008’s Health Stories,” the story groups the tainted heparin with salmonella-tainted jalapeno peppers imported from Mexico on its list of food and drug scares. Contaminated heparin keeps company on that list with with the FDA’s warning about over-the-counter cold meds for young children and the American Cancer Society’s announcement that for the first time since 1998, when statistics began to be compiled, the number of people who developed cancer or died from the disease has dropped.

Here’s to a happier, healthier New Year!

SOURCE: Heparin Recall › Heparin scandal makes 2008 top 10 lists

Allie recently posted a video on YouTube in light of the heparin scandal, asking “Is my insulin tainted?” Last year, more than 80 Americans died and hundreds more were sickened after receiving doses of the blood thinner heparin. An investigation found that batches of heparin manufactured at Baxter International’s China facility had been contaminated. That led to a recall, and further questions about the quality of the foods and drugs imported into the United States from foreign countries, especially China.

Demanding answers, Allie made phone calls to insulin companies and 24 hours later, reported on her results. Her first call was to Sanofi Aventis, a pharmaceutical company based in Bridgewater, NJ. Sanofi Aventis manufactures medications such as Allegra, Ambien, and Ketek as well as diabetes medications such as insulin glargine injection Lantus and insulin gluisine injection Apidra. Allie reports that she was able to speak with a customer service representative with Sanofi Aventis who informed her that the raw materials are manufactured in Germany and are “completely FDA approved and do not come from China.”

Allie compared her attempts to reach Eli Lilly and Company’s customer service as being in the “twilight zone.” Her repeated calls “during normal business hours” were either cut off or unanswered. Lilly is the 10th largest pharmaceutical company in the world and offers a variety of products. It’s diabetes products include Byetta, Gluagon and Humulin.

Allie then called Novo Nordisk, a manufacturer and marketer of pharmaceutical products and services headquartered in Denmark. Novo Nordisk offers a line of diabetes products such as insulin pens, needles and hypokits. She was told that its diabetes products are bottled in North Carolina.  Its FlexPen is manufactured in Denmark. Customer Service assured her they follow FDA guidelines and run batch tests to ensure safety.

SOURCE: Heparin Recall › Diabetic questions safety of insulin in light of heparin scandal

According to the report, the Institute of Medicine issued a statement recommending the USDA’s Food Safety and Inspection Service and the food safety activities of the FDA within HHS should be unified. The consumer groups argue that combining the two agencies would cause the dysfunctional FDA program to undermine the good work of the USDA. Thus, the groups are recommending reforming the food inspection process.

The FDA is a hot topic for the Obama administration. The agency has come under fire in recent months for its handling of contaminated foods and tainted imports. Last spring, the agency incorrectly identified the source of a salmonella outbreak to tomatoes before concluding that jalapeno peppers from Mexico were the cause.

And, earlier this month, Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee questioned the FDA’s handling of the contaminated heparin scandal that caused more than 80 Americans to die and hundreds more to fall ill. The heparin was found to have been contaminated at a China manufacturing plant. After issuing a recall on the tainted heparin, the FDA admitted it did not have the staff to fully inspect all foreign food and drug manufacturing plants to ensure quality and safety of drugs imported into the United States.

SOURCE: Heparin Recall › Consumer groups, institute team up to urge FDA reform

The news is a double-blow for Europeans, not only for the 43 employees who lost their jobs, but for consumers who have expressed concerns about the quality of drugs and other products made and manufactured in China.

Products made in China have been continuously under fire for the past several months, from milk tainted with melamine to toys covered with toxic lead paint. Earlier this year lots of the blood thinner heparin manufactured in China were recalled after more than 80 Americans died and hundreds more fell ill after receiving doses of heparin. Select batches of heparin were found to have been contaminated during production at Baxter International’s China plant.

Since then, the FDA has announced plans to better track imports of food and drugs. One of its first steps was to open three offices in China to oversee quality control standards of products imported to the United States. Another 50-plus offices will be opened worldwide, though the agency says it could take years to effectively inspect all foreign facilities.

According to Bloomberg, China has more than 700 plants registered to ship drugs to the United States – more than any other country.

SOURCE: Heparin Recall › Europeans now dependent on China for Panadol, Tylenol

Last year, heparin was thrust into the spotlight after more than 80 patients who had received the blood thinner died and hundreds more became ill. An investigation to the adverse reactions found that batches of heparin manufactured in Baxter International’s China plant were contaminated with over-sulfated chondroitin sulfate (OSCS). That discovery spurred the FDA to recall lots of heparin made by Baxter International.

“Perhaps the most surprising fact that emerged in our three months of reporting on contaminated heparin ingredients from China: The U.S. government has little ability to know whether the drugs we are taking are safe or not,” Eisner points out.

Last month, the FDA vowed to step up its efforts to oversee quality control of imported foods and drugs by opening offices in foreign countries. Its first offices opened in China. The FDA plans to place more than 60 food and drug regulators worldwide over the next several months. However, the agency says it will take more than a decade to adequately inspect all foreign drug manufacturing plants.

“As a result,” Eisner writes, “doctors must take it on faith that the medicines they are prescribing are exactly what they are supposed to be.”

SOURCE: Heparin Recall › Tainted heparin may have caused death of infant

Heparin is generally used when a patient – adult or infant – receives fluids through a central line to prevent a blood clot from forming, which could eventually grow and break off and kill a patient. But if the blood is too thin, it puts the patient at risk for life-threatning bleeding or hemorrhages, including in the brain.

The Quaids also sued Baxter Healthcare Corp. over the packaging and labeling of its high-dose and low-dose heparins, arguing the two bottles are easily confused. Other cases of heparin overdose have been reported and linked in part to the confusing packaging. The Quaid’s lawsuit against Baxter was dismissed, according the Associated Press.

Baxter International has faced numerous lawsuits lately, most notably for the tainted heparin scandal earlier this year. More than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter International’s China plant. An investigation found that lots made in that plant were contaminated with over-sulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death. The FDA issued a recall on batches of Baxter’s International’s heparin.

The Associated Press reports that the petition filed Monday in the Quaid-Cedars-Sinai case indicates that Baxter International may also sue Cedars-Sinai for improperly administering the blood thinner to several patients at the hospital, including the Quaid’s newborn twins.

SOURCE: Heparin Recall › Quaids get settlement in heparin overdose case

Franke Leon Isom of Webster, Ken., died Dec. 14, 2007, a day after he was given heparin during treatment at Woodland Dialysis Clinic in Elizabethtown. Attorneys argue that Isom received part of the 55,000 gallons of heparin that was contaminated with over-sulfated chondroitin sulfate (OSCS).

Earlier this year, a series of deaths and adverse allergic reactions from patients who had received doses of heparin led to an investigation that linked the reactions to lots of heparin made at Baxter International’s China plant. Further review found the heparin had been contaminated with OSCS during manufacturing in China. Shortly thereafter, the FDA ordered a recall. The tainted heparin is blamed for more than 240 deaths worldwide and caused hundreds more people to fall ill from allergic reactions to OSCS, such as hypotension.

The lawsuit, filed on the behalf of Isom’s estate, is one of 50 similar civil tort claims against Scientific Protein Laboratories and Baxter International, according to the news report. Attorneys argue that recalled lots of heparin were still found on hospital shelves months after the recall went into effect.

SOURCE: Heparin Recall › Another lawsuit filed in tainted heparin scandal

Heparin from another company, APP Pharmaceuticals Inc., wasn’t considered a problem, though in a letter to Congress in October, the FDA said one patient taking the APP heparin had a severe reaction that may have led to his death, according to the news report. APP responded in a letter to the congressman’s staff that the company had thoroughly reviewed the case and did not believe the patient’s death was a result of contaminated heparin.

Rep. Barton wants to know why the FDA has “no information” about whether that patient’s death was caused by the same contaminant – over-sulfated chondroitin sulfate – as was found in Baxter International heparin.

Rep. Barton has been on the FDA’s case for more than a month, questioning the agency’s handling of the heparin recall, claiming it misrepresented deaths tied to the product , arguing that it didn’t thoroughly investigate the matter, and ordering answers on why the agency took six months to seize lots of contaminated heparin from an Ohio agency.

SOURCE: Heparin Recall › Barton wants answers from FDA about heparin scandal

Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year.

The FDA ordered a recall on batches of the blood thinner heparin made at Baxter International’s Chinese facility after some lots were found to have been contaminated with over-sulfated chondroitin sulfate. The tainted heparin killed more than 80 Americans and sickened hundreds more before the contaminant was identified and linked to the China plant.

Over the past several months the FDA continued to come under fire for its handling of the heparin recall. Last week, Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee, questioned why the FDA waited six months to seize lots of contaminated heparin from Celsus Laboratories in Ohio. Last month Rep. Barton also asked the Government Accountability Office to look into the agency’s overall handling of the recall.

Despite the criticism, von Eschenbach has been favorably regarded for strengthening the agency’s international food and drug regulations, opening three offices in China last month and vowing to place more than 60 food and drug regulators worldwide to oversee quality standards of food and drugs imported to the United States.

President-elect Obama is considering a list of candidates to succeed von Eschenbach that includes Baltimore’s health commissioner, several prominent physicians, and former and current FDA officials, according to AP.

SOURCE: Heparin Recall › FDA commissioner announces plans to resign next month

Earlier this year, the FDA recalled lots of heparin manufactured in a Baxter International Chinese plant after batches were found to have been contaminated with over-sulfated chondroitin sulfate. The FDA recall was the result of an investigation into the deaths of more than 80 people and illnesses of hundreds more people after receiving doses of heparin.

CNN Money reports that the recall process is voluntary. Companies are not required to immediately comply with the FDA’s request, however FDA inspectors reportedly told Celsus Laboratories in April that its recall efforts were insufficient, and a month later followed up in a letter to the company expressing the same concerns. Last month, the FDA seized 11 contaminated lots of heparin from Celsus Laboratories.

The FDA won’t elaborate on why Celsus Laboratories’ efforts were less than satisfactory, saying its investigation into the matter is still ongoing. The agency did say that on occasion it sends safety officers to companies to conduct “100 percent effectiveness checks” to ensure they are taking proper measures to destroy the recalled products.

Rep. Joe Barton, a member of the House Energy and Commerce Committee, has been following the heparin situation and, last month, asked the Government Accountability Office to look into the matter. The congressman also wrote a letter to the FDA commissioner saying he wants to know when the agency first decided it was appropriate to seize heparin from Celsus Laboratories. He also asked for a list of all individuals involved in the decision to seize the heparin.

SOURCE: Heparin Recall › Congressman questions FDA’s slow action on heparin seizure

The Web site details the safety measures the pharmaceutical company has taken over the past several months, including enhanced labeling, unit-of-use bar codes, large lettering and color-coded bottle stoppers to help eliminate misuse of its products, which also includes injectible drugs for oncology.

APP Pharmaceuticals became the only U.S. provider of the blood thinner heparin after batches of heparin manufactured at Baxter International’s Chinese plant were found to have been contaminated. The tainted heparin killed more than 80 Americans and sickened hundreds more before the FDA pinpointed the source of contamination and issued a recall of the specific lots.

APP Pharmaceuticals has two U.S. manufacturing plants and one in Puerto Rico, however it imports its raw material from a Chinese supplier.

Heparin also was thrust into the spotlight in 2007 with the much-publicized overdosing of actor Dennis Quaid’s newborn twins. The newborns nearly died after they were accidentally given 1,000 times the intended dose. Other cases of heparin overdose have been reported and linked in part to similar packaging of high-dose and low-dose heparin.

APP Pharmaceuticals‘ safety initiative comes on the heels of new federal requirements for health care facilities that go into effect January 1, requiring health care facilities to have in place a comprehensive anticoagulation management plan in order to be accredited by the U.S. Joint Commission.

SOURCE: Heparin Recall › Drug company launches Web site to highlight safety measures

First, researchers noted that the evaluations were short term and that many of the studies were supported by the generic drug companies, who have a vested interest in the positive outcome of the results.

Furthermore, the story points out that generics are more likely to be made in factories in other countries where labor and overhead are far less expensive, such as India and China. In fact, China is producing more and more generic drugs and, according to the story, is expected to offer even lower prices in the future.

This should raise concerns with the general public, given the tainted heparin scandal earlier this year that killed more than 80 Americans and sickened hundreds more. That tainted heparin was traced to manufacturing plants in China and resulted in a major recall of the blood thinner.

The FDA is hoping to give more guidance on U.S. quality control standards on imported food and drugs by opening offices and placing regulators in foreign countries. The first office opened in Beijing last month. However, congressional investigators say that inspecting the more than 3,000 drug plants in other countries could take more than a decade.

SOURCE: Heparin Recall › Generics may be bio-equivalent of brands, but are they as safe?

Baxter International makes heparin, the blood thinner that is routinely used before treatment for kidney dialysis to prevent blood clots as well as during many surgeries. Several lots of heparin manufactured in Baxter International’s China plant were recalled by the FDA earlier this year after they were found to have been contaminated during manufacturing. The tainted heparin ultimately killed more than 80 Americans and sickened hundreds more before an investigation led them to Baxter International’s China plant.

The company also lobbied on bills to improve the safety of drugs imported from foreign countries, and stood up against an effort in Congress to reform the U.S. patent system. According to the story, high-tech companies support that bill, claiming that it would cut down on “frivolous patent-infringement lawsuits.” Baxter International and the pharmaceutical industry argued that doing so would weaken patent protections on drugs by reducing infringement penalties. The bill passed the House but is not expected to pass the Senate this year.

Baxter International also lobbied to give the FDA authority to approve generic versions of biotech drugs, which have never faced generic competition because the FDA does not have the authority to approve the less expensive versions.

SOURCE: Heparin Recall › Baxter International spent thousands on lobbying efforts

“Previously it was nearly impossible to change the nature of the heparin generated by the enzyme,” said Jian Liu, Ph.D., associate professor at the UNC Eshelman School of Pharmacy medicinal chemistry and natural products division. “The degree of difficulty was 10-plus. Now it’s more like a two or three, which opens the door to the possibility of improving on the natural product.”

The method involves modifying the enzyme heparan sulfate 2-O-sulfotransferase, which produces heparin in the human body in addition to other heparin-like molecules. By modifying 2-O-sulfotransferase, researchers will be able to create customized forms of synthetic heparin with different properties, according to the report.

Heparin is typically administered to most patients during surgery and before some treatments such as kidney dialysis to prevent blood clots from forming. Heparin is produced naturally by most animals, including humans, but most heparin available today is derived from pig intestines. China has become a popular location for manufacturing heparin because it has a much larger pig population.

However, heparin manufactured in China raised concerns earlier this year after batches from Baxter International’s China plant were found to have been contaminated. The investigation into heparin resulted after more than 80 Americans died and hundreds more were sickened after receiving doses of the tainted heparin. As a result, researchers have been working to find safer alternatives to heparin, including developing synthetic versions.

“The pig stuff has served us well for 50 years and is very inexpensive, but if we cannot control the supply chain, we cannot ensure the safety of the drug,” Liu said. “I am working for the day when synthetic heparin can be brewed in large laboratories at a low cost.”

Liu and her colleagues also are looking into customizing heparin for other uses, such as a treatment for small-cell lung cancer.

Liu’s research recently was published online in the journal Proceedings of the National Academy of Sciences.

SOURCE: Heparin Recall › Scientists on road to modifying, customizing human heparin

Batches of heparin were recalled by the FDA earlier this year after lots manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate. The investigation and subsequent recall followed reports of more than 80 deaths and thousands more illnesses of patients who had received doses of heparin from the lots in question.

Rep. Joe Barton, R-Texas, last week pointed out that the FDA made conflicting statements to the public and Congress about the number of deaths caused by the blood thinner. Last May, the FDA said it completed a review of three deaths linked to the tainted heparin. Last month, the FDA told Congress that only two deaths were possibly linked to the incident and the third was “unassessable.”

Baxter International, the company involved in the tainted heparin incident, conducted its own investigation and determined that the contaminant was likely not the cause of death in any of the three cases mentioned by the FDA. Baxter’s investigators reviewed patient medical records, interviewed pharmacists and nurses, and visited a hospital where one of the patients had gone before dying.

The FDA came under fire over the tainted heparin scandal after admitting it did not properly inspect Baxter’s China facility. Inspecting all foreign drug manufacturing facilities could take as long as 13 years, the agency has reported. This week the FDA opened its first foreign office, located in Beijing, China, as part of a push to place more than 60 food and drug regulators worldwide to provide guidance on U.S. food and drug quality standards.

SOURCE: Heparin Recall › Lawmaker questions FDA investigation of heparin scandal

The move is part of the agency’s effort to place more than 60 food and drug regulators worldwide over the next year. The offices replace the FDA’s previous practice of sending staffers on individual assignments to inspect foreign facilities.

The agency’s Beijing office, which opens Wednesday, will be the first. Thirteen employees will be assigned to work in the China offices.

The AP quoted a statement from the office of U.S. Health and Human Services Secretary Mike Leavitt: “Establishing a permanent FDA presence in China will greatly enhance the speed and effectiveness of our regulatory cooperation and our efforts to protect consumers in both countries.”

The FDA is placing offices worldwide with particular attention to India, Latin America and the Middle East. However, placing offices in China became a priority as a result of numerous reports of contaminated food and drug products manufactured in China. Among the products made in China and recalled by the FDA were batches of the blood thinner heparin, which were found to have been contaminated with over-sulfated chondroitin sulfate (OACA). More than 80 Americans and hundreds more fell ill after receiving the contaminated heparin.

SOURCE: Heparin Recall › FDA opens first foreign office in Beijing this week

During dialysis, patients are hooked up to a machine that draws out the blood through tubing. Since blood tends to clot when it moves through the tubing, patients routinely are given the blood thinner heparin to prevent clotting.

One week before Christmas, after two months of regular dialysis, Bonnie fell ill with diarrhea, vomiting and soon, severe pain in her chest and abdomen. She was rushed to intensive care and within days was unconscious and on a breathing tube. The doctors said there was no more she could do. Leroy’s wife was suddenly and unexpectedly dead.

As Leroy tried to cope with the loss of his longtime wife, their son Randy suddenly became sick with the same symptoms. He was born with the same genetic kidney disease as his mother, and was receiving regular dialysis treatments. His wife, a dialysis nurse, tried desperately to revive him but it was no use. Randy died just three weeks after his mother.

Both Bonnie and Randy were victims of tainted heparin, batches of the drug manufactured in China and later found to have been contaminated with over-sulfated chondroitin sulfate (OSCS). The Hubleys were just two of more than 80 deaths caused by the contaminated heparin. Several hundreds more were sickened by the drug before the FDA recalled batches made in the Baxter International Chinese plant. To date, the FDA has recalled 13 different contaminated medical products containing heparin from various companies.

Last week had U.S. Marshals raided Celsus Laboratories Inc., and found 11 lots of the tainted blood thinner that had not been removed. The recalls and FDA crackdowns come too late for the Hubley family and for the hundreds of families affected by the contaminated heparin. We need to be assured that the contaminated heparin is removed for good so that no more lives are in jeopardy.

SOURCE: Heparin Recall › Time shares story of family affected by heparin contamination

“It’s really horrible for two reasons: one, that a company that knows that their product is not a good product that should be distributed and they’ve been told so,” said Dr. Lynne Wagoner, a Christ Hospital Heart Specialist, who was quoted in the story by WTOL-TV in Toledo, Ohio.

Earlier this month, U.S. Marshals seized a total of 11 lots of the blood thinner at Celsus Laboratories Inc. Heparin was recalled earlier this year after an FDA investigation found that batches of the blood thinner were contaminated with over-sulfated chondroitin sulfate (OACA) at a manufacturing plant in China. The investigation was launched after more than 80 Americans died and hundreds more fell ill after receiving the medication.

The FDA said Celsus Laboratories did not sufficiently carry out the recall process by notifying customers of the contaminant in the heparin it provided. The company distributes both heparin lithium and heparin sodium USP, both of which fell under the recall. As a result, the FDA issued an advisory to manufacturers who may have purchased heparin from Celsus Laboratories to contact the company to make certain they are not using a product from the contaminated batch.

The FDA has recalled 13 different contaminated medical products containing heparin from various companies.

SOURCE: Heparin Recall › Doctors outraged by heparin seizure

Heparin is routinely used before certain types of surgery or other procedures are preformed to prevent clotting. Afterward, doctors will often remove the blood thinner to avoid unwanted bleeding by using the medication protamine.

Protamine is a weak anticoagulant drug that is administered intravenously and acts as a heparin antagonist. But protamine carries a risk of serious side effects such as difficulty breathing; swelling of the mouth, face, lips or tongue; wheezing; muscle pain; confusion; fainting; fast or irregular heartbeat; mood changes; seizures; slurred speech; headache; loss of consciousness; unusual hunger; unusual sweating; and weakness.

Many people also experience allergic reactions from heparin, including organ failure, heart problems and shock. Batches of the drug also have been recalled or seized by the federal government after more than 80 people died and hundreds more were sickened by heparin that was found to have been contaminated during manufacturing.

In an effort to find a safer product to remove heparin from the bloodstream, Krzysztof Szczubialka and his team of researchers have developed a new product made of microscopic polymer beads from modified chitosan, a product of shellfish. Lab tests show that the new material reduced heparin concentrations to nearly zero within 10 minutes. The product will be detailed in the December issue of American Chemical Society’s monthly journal, Biomacromolecules.

SOURCE: Heparin Recall › Scientists develop heparin antagonist medication

The FDA ordered U.S. Marshals to seize the products today. Mike Chappell, acting associate commissioner for regulatory affairs for the FDA is quoted as saying, “This action will help prevent this contaminated heparin from finding its way into the marketplace.”

Earlier this year, heparin manufactured by Baxter International, Inc., was found to be contaminated with OSCS. That heparin also contained components manufactured in China, which is believed to be the source of the contamination. The Baxter contamination led to hundreds of injuries and 81 deaths.

The FDA news release states that the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies, to date this year.

Information in the news release indicates the Celsus heparin entered the United States before the establishment of FDA import controls for the drug, and was reviewed by the FDA after it was processed at Celsus as a part of the agency’s process to implement the controls.

The release also indicates that the FDA knew about the contamination in April 2008, when it warned Celsus Laboratories during an inspection that the company’s actions to notify customers about the contaminant were insufficient. The FDA says it warned Celsus again that it needed to step up its efforts to notify customers about the potential hazard in a May 8, 2008 letter. Finally, today the FDA seized the contaminated product from the lab.

Manufacturers who may have purchased heparin from Celsus are urged to contact the company immediately to make sure they are not using any heparin from the since-seized lots. The product does not meet acceptable quality standards, the release says.

SOURCE: Heparin Recall › Contaminated heparin removed from Cinnicinnati plant

The method uses a machine that removes blood from a patient through an IV, separates it into red blood cells and plasma, and returns the red blood cells back into the patient’s arm. The plasma is then infused with the blood thinner heparin, which binds to the low-density lipoprotein (LDL), or “bad” cholesterol, and separates from the plasma. The LDL is then filtered out and the remaining plasma is put back into the patient’s vein. The process filters about half of the body’s total supply of blood, removing more than half of the LDL cholesterol. The process can be repeated every two weeks as LDL builds back up.

High cholesterol, especially high LDL levels, can clog arteries to the heart and brain, which can cause heart attacks and strokes.

Innovative uses for heparin present the need for more safeguards to protect recipients of pharmaceutical medications. Batches of heparin made by Baxter International were recalled earlier this year after numerous patients died or became ill after receiving injections of heparin. The drug was later found to have been contaminated at Baxter’s Chinese manufacturing plant.

The LDL-removing treatment, which has been available in the United States for about 10 years, is generally available only to individuals with LDL levels that stay above 300 even after drug therapy, diet and exercise. However, because of its high expense and low number of eligible patients, few machines are readily available.

SOURCE: Heparin Recall › Heparin used in innovative cholesterol-separating method

Early last year, more than 80 people died and thousands more were sickened after receiving the blood thinner heparin. It was later found that specific lots had been contaminated at a manufacturing plant in China.

Even more were harmed recently when 50,000 children were sickened by milk from China that was contaminated by melamine, a product used in the manufacturing of plastics, fertilizer, paint and adhesives that can be lethal to infants.

This, just a year after parents around the world were urged to dig through their children’s toy boxes in search of Barbies, Batman action figures and Thomas the Train cars that was found to be contaminated with high levels of lead paint. The Mattel toys – which included several different products and numbered more than 21 million worldwide – were made in China. Lead paint can be especially damaging to the nervous system, cause hearing loss, stunt growth and delay development. It also can cause reproductive problems in adult men and women.

Now there is a new recall on a product made in China. The U.S. Consumer Product Safety Commission (CPSC) and Delta Enterprise Corp., just announced a voluntary recall of 985,000 drop-side cribs because of a risk of entrapment and suffocation to infants. The CPSC is aware of the death of an 8-month-old who became entrapped and suffocated, two entrapments, and nine disengagement incidents.

The recall includes selected Delta crib models manufactured in Taiwan or Indonesia between 1995 and 2005, and one model made in 2007. The cribs were sold at major retailers between 2000 and 2007. Delta cribs currently sold at retailers on not included in the recall.

Parents and caregivers are urged to stop using the cribs immediately and call Delta at (800) 816-5304 or go to www.cribrecallcenter.com for a free repair kit.

For specific model numbers, click here.

SOURCE: Heparin Recall › More products made in China recalled for harming infants

Baxter International is the world’s largest maker of blood-disease treatments. The company also sells the blood thinner heparin, which last year was recalled after batches of the drug made in the company’s Chinese plant were found to have been contaminated. As a result, more than more than 80 people died and hundreds more were made ill after receiving the tainted heparin. At that time, Baxter was the largest heparin manufacturer, with $30 million in sales.

Most of the heparin sold in the U.S. is manufactured with ingredients made in China. China is the leading supplier of the drug largely because heparin is made from pig intestines and China has a much larger pig population, according to Natural News.

At least 12 lawsuits have been filed against Baxter by patients and family members of those who suffered ill effects of the tainted heparin. As yet, Baxter has not incurred any serious legal costs from the tainted heparin crisis, Natural News reports.

In its third-quarter report, Baxter International announced that its net income increased from $395 million to $472 million, or from 61 cents a share to 74 cents a share. Much of its profit increase is attributed to international sales of products that treat hemophilia and immune disorders.

The company is predicting continued sales growth of about 5 to 6 percent, and expects cash flow from operations to exceed $2.6 billion.

SOURCE: Heparin Recall › Despite recall, Baxter International enjoys third-quarter gains

The blood thinner heparin made news recently when the FDA recalled batches of heparin after more than 80 people died and several others became ill after receiving heparin. It was later determined that heparin made by Baxter International was contaminated in the company’s Chinese manufacturing facility.

While heparin is considered an effective treatment for preventing blood clots and is widely used, it must be injected, which makes long-term therapy difficult. The new drugs would be taken by mouth, which would make dosing easier and eliminate the need for laboratory monitoring.

Heparins garner about $700 million in annual sales, with Sanofi-Aventis’ Lovenox making up nearly two-thirds of the world’s share of the drug. Pfizer’s Fragmin and GlaxoSmithKline’s Fraxiparine account for 6.3 and 5.9 of sales, respectively. Vitamin K Antagonists are responsible for more than $6 billion in sales worldwide, with Bristol-Myers Squibb’s Coumadin, Barr’s Warfarin and Eisai’s Warfarin owning slightly more than half the market’s share.

Three of the five companies are in the late phases of clinical testing, two of which already have been approved in Canada and are awaiting approval in the United States. Two other companies’ drugs have been approved for short-term use in Europe.

SOURCE: Heparin Recall › Pharmaceutical companies developing drugs to fight blood clots

“We are sending a very clear message to producers: if you want to have access to our market you need to make products that meet our standards of quality,” Health and Human Services Secretary Michael Leavitt was quoted in the story. Leavitt oversees the FDA and other federal health agencies.

While particular attention will be paid to India, Latin America and the Middle East, the FDA will make China a priority, establishing its first office in Beijing by the end of the year. The Beijing office will employ eight U.S. staffers. Additional outposts are planned for Shanghai and Guangzhou.

Products made in China have caused much heartache lately. Last spring, the FDA
recalled batches of heparin after some lots were found to have been contaminated while produced in Baxter International’s Chinese factory. The tainted heparin killed more than 80 people and sickened hundreds more.

Similarly, dozens more products made in China have been recalled over the past several months for harming people, including tainted baby formula, toys made with lead-based paint, and contaminated pet food.

Details on how the FDA will carry out the plan are unclear, as FDA officials admit that the hiring of several dozen more staffers, as the plan lays out, would not provide enough personnel to visit the thousands of plants around the world.

SOURCE: Heparin Recall › FDA to set up offices worldwide

FDA approval isn’t a guarantee of safety. For example, last spring, FDA-approved batches of heparin were recalled after they were found to have been contaminated. The tainted drug killed more than 80 people and sickened hundreds more before the FDA recalled the medication.

At issue in the new Supreme Court term is the “final rule” established on June 30, 2006, by the FDA. That rule protects drug companies whose drugs have harmed others from lawsuits by individuals who have been harmed. This extends to companies that deliberately withheld information that would have proven their drug to be harmful.

According to the Natural News story, the FDA runs without oversight and has declared that it gets the final word on a drug’s safety regardless of its harmful effects. Therefore, both the FDA and the pharmaceutical companies it represents are protected from suits under this arbitrary rule.

The Supreme Court currently is considering a lawsuit against drug-maker Wyeth and its drug Phenergan after a woman who received an injection of the nausea drug led to a gangrene infection that resulted in the amputation of her arm. Wyeth is accused of inadequately warning about the risks involved with this type of injection.

SOURCE: Heparin Recall › High court rule may affect right to sue drug makers

“With more drug companies buying ingredients and producing products overseas, country-of-origin labeling is more important than ever,” Sen. Brown said in a press release.

Country-of-origin labeling for active pharmaceutical ingredients was initially proposed last April as part of the Food and Drug Administration (FDA) Globalization Act. Sen. Brown’s proposal would require similar labeling for active ingredients as well as inactive ingredients on both prescription and over-the-counter medications.

The bill comes on the heels of the FDA recall of heparin last spring, which was found to have been contaminated at Baxter International’s China manufacturing plant. The contaminated heparin killed more than 80 people and sickened hundreds more.

The bill coincides with new provisions for country-of-origin labeling of food products. As of September 30, 2008, retailers must notify their customers of the country of origin of commodities outlined by the newly amended Agricultural Marketing Act of 1946.

With so many alarming recalls from China – from contaminated heparin and baby formula to toys laced with lead paint and generators plagued by fire hazard claims – knowing where our medications and food originate will help us all make more informed decisions whether to buy them.

SOURCE: Heparin Recall › Senator proposes country-of-origin labeling for medications

Italian researches carefully selected 700 of the “lowest risk” patients to participate in the trial. This included patients with single blockages of a heart artery, currently taking two clot-preventing medications such as aspirin and thienopyridine, and with no immediate danger of heart attack.

The study found that the incidence of heart damage and bleeding events were lower in the patients who participated in the study, and there was a lower risk of death, heart attack or blood vessel problems.

According to the American Heart Association, the artery-opening procedure, formerly called percutaneous coronary interventions, is a procedure used to treat patients with diseased arteries of the heart. For example, chest pain caused by a build-up of fats, cholesterol and other substances from the blood that can reduce blood flow to a near trickle or heart attack caused by a large blood clot that completely blocks the artery.

The Italian study cautioned that using no heparin is a bold step and one that should be taken only after serious consideration and evaluation of the patient’s health.

While more work is needed to confirm the results, some researches applaud efforts to move medical innovations like this forward. This is especially welcome news considering the recent contaminated heparin scare that killed more than 80 Americans and sickened hundreds more.

SOURCE: Heparin Recall › Artery procedures successfully performed without heparin

Nearly 100 pharmacists and the hospitals they work for were fined $2,000 to $5,000 by the Board of Pharmacy, according to the report.

The Food and Drug Administration (FDA) recalled heparin early last year after a large number of patients suffered adverse effects after taking the drug. The FDA later determined that batches of heparin made in China contained a contaminant that ultimately killed more than 80 people and made hundreds more ill.

In 2004, California took the lead in making sure recalled medicines were removed from pharmacy and hospital shelves by becoming the only state in the country to approve a stringent electronic system for drug makers, wholesalers and pharmacies to track all prescription drugs from manufacturer to patient, according to the San Francisco Chronicle.

But implementing this system has been challenging. The law originally was set to go into effect in 2007, but was delayed until January 1, 2009. Last March, the California Board of Pharmacy voted to give until Jan. 2011 to start electronic tracking. Board officials were concerned if they did not extend the deadline that the law would be poorly implemented or drug makers would refuse to sell their medications in California.

SOURCE: Heparin Recall › Recalled heparin still appearing in hospitals, pharmacies

Alchemia’s CEO, Dr Peter Smith said “The impending commercialization of generic fondaparinux and anticipated revenues in calendar year 2009 will form a strong financial base for Alchemia. This will enable the company to advance its drug targeting and drug discovery technologies to further build a sustainable pipeline of opportunities for future commercialization.”

The company’s report states: “Given the complexity of the synthesis, Alchemia continues to believe that its generic fondaparinux will be the only generic brought to market, restricting competition to two drugs, Alchemia’s fondaparinux and GSK’s Arixtra. Typically, a first generic will take 40-50 percent of the prescription share, and with Alchemia’s fondaparinux expected to be the sole generic, a modest level of price discounting is anticipated.”

Arixtra is the only heparin drug not derived from biological sources as it is a synthetic molecule. Thus, it was not among the recent heparin recall.

Alchemia contends that there are no significant technical hurdles remaining and that generic fondaparinux approval and launch is expected in the first half of 2009, depending on review time at the FDA.

SOURCE: Heparin Recall › Synthetic heparin expected to launch early 2009

Lovenox, the company’s number one selling medicine, was first recalled last June after some batches of its pre-filled injectible solution were found to be contaminated with trace amounts of oversulphated chondroitin sulphate, according to Reuters.

Oversulphated chondroitin sulphate is the same contaminate found last March by the Food and Drug Administration (FDA) in batches of heparin that killed more than 80 Americans and sickened hundreds more. Those batches were traced back to Baxter International’s Chinese plant.

The level of contaminant found in Lovenox was much lower than what was found in the heparin manufactured by Baxter International, according to Forbes.

So, what exactly is oversulphated chondroitin sulphate?

According to a March 20, 2008, New York Times report, chondroitin sulphate is an inexpensive and readily available dietary supplement made from animal cartilage. In its natural state chondroitin sulphate does not have anticlotting properties, however when it is altered to what is called oversulphated chondroitin sulphate, it mimics heparin.

According to the FDA, oversulphated chondroitin sulphate is not an approved drug in the U.S., nor should it be found in heparin, as it likely caused the allergic reactions that have killed and sickened so many individuals worldwide.

SOURCE: Heparin Recall › French Lovenox brand heparin recall

In recent weeks, according to a Reuters/The Epoch Times, three children and more than 6,000 infants have become ill after consuming infant formula contaminated with toxic melamine, according to Reuters/The Epoch Times.

Let’s recap some of the other made-in-China scares that plagued the United States, highlighted in the story:

More than 200 cats and dogs died and thousands more became ill when melamine was discovered in China-made pet foods. As a result, more than 100 brands of pet food were recalled in North America in March 2007.

A month later, the U.S. National Highway Traffic Safety Administration (NHTSA) recalled 450,000 tires made by China’s second-largest tire maker, Hangzhou Zhongce Rubber Co. Ltd., for an insufficient or missing gum strip.

A year ago, the world’s largest toymaker, Mattel, recalled more than 18 million small, powerfully magnetic toys that were made in China because, if swallowed, could cause serious injury. Two weeks later, the company recalled 1.5 million toys because of concerns over lead paint.

According to the story, other Chinese-made products such as toothpaste, cough syrup, eggs, lipsticks, dumplings and fish also were cited as causing possible health risks to individuals in China and other parts of the world.

SOURCE: Heparin Recall › China-made products cause safety concern

According to a report in the Pharmaceutical Business Review, APP currently manufactures nine products at its Puerto Rico facility, including doxycycline, azithromycin and diphenhydramine. The report says the company plans to manufacture more than 19 million units in Puerto Rico during 2008 and to eventually transfer more than 25 additional product codes to the facility.

The recall of contaminated heparin manufactured in China has affected the availability of the product, which is a blood thinner used in surgical procedures.

Baxter International, Inc., recalled all remaining lots and doses of its sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products, both preserved and preservative-free, in February, and suspended production of the products. Prior to the recall, Baxter manufactured about half the multidose vials used each month by health care providers.

APP expects the transfer of its additional product codes to the Puerto Rico facility will translate to approximately 50 million units annually. APP currently has manufacturing facilities in Illinois and New York.

Pharmaceutical Business Review quotes Tom Silberg, CEO of APP Pharmaceuticals, as saying, “Bringing this third manufacturing site on-line is an important part of our commitment to ensuring that an uninterrupted and safe supply of heparin of the highest quality is available for US patients.”

Founded in 1996, APP Pharmaceuticals is a leading manufacturer of multi-source and branded injectable pharmaceutical products for acute medical care both in patient and ambulatory settings.

SOURCE: Heparin Recall › APP ok to make heparin in Puerto Rico

Linhardt was among the researchers who discovered the source of tainted heparin that was responsible for at least 149 deaths since the beginning of 2007. Manufacturer Baxter International, which supplies about half of the heparin used in the U.S., recalled its supplies of heparin made in China after more than 80 patients suffered serious allergic reactions and death following its use.

According to a report by Bloomberg News Service, Chinese pig farms that provide source material for heparin are not monitored by the U.S. Food & Drug Administration, which increases the risk for contamination. Continued use of traditional heparin products manufactured in these facilities leaves the door open for another contamination event, Linhardt says in the Bloomberg report.

In addition to Baxter’s product, a smaller scale contamination problem was reported with the Lovenox heparin medicine manufactured by Sanofi-Aventis, according to a report by Reuters.

Linhardt presented his team’s synthetic heparin results at the recent American Chemical Society meeting, according to Reuters, where he told those in attendance that today’s heparin manufacturing methods are “simply unsafe.”

Scientists are working on creating larger quantities of the synthetic heparin, which Linhardt hopes will reach human clinical trials in five years, Reuters reports.

SOURCE: Heparin Recall › synthetic heparin in development

The new expanded recall includes all remaining lots and doses of Baxter’s heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products, both preserved and preservative-free. The recall will not include Baxter’s heparin pre-mix IV solutions in bags.

Although there was a danger of contamination that could result in adverse patient reaction, the U.S. Food & Drug Administration did not require Baxter to do a full recall of the product in January because pulling all of the product could create a shortage for operating rooms, dialysis centers and other critical areas that use the product, which is a blood thinner.

According to a Baxter news release, in January the FDA determined the risk of patients not receiving any heparin blood thinners when it was critically needed was greater than that of patients receiving contaminated product. Baxter is one of the leading suppliers of heparin products, manufacturing about one half of the multidose vials used each month by health care providers.

The FDA now feels there is enough heparin available from other sources to allow Baxter to pull its remaining, possibly contaminated, product.

Customers are advised to immediately discontinue use of recalled product, and to contact Baxter for return and replacement.

Despite FDA assurances that there is enough heparin product in the market to treat critical patient needs, by March health care providers were being more careful with prescribing their existing supplies as a result of the more limited supply.

SOURCE: Heparin Recall › Baxter expands heparin recall

The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high “bolus” doses of the drug.

Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear.

Heparin sodium is derived from pig intestines and has been marketed in the United States since the 1930s. Millions of patients benefit from the intravenous administration of this drug every year to avoid potentially life-threatening blood clots in the veins, arteries, and lungs.

“FDA concurs with Baxter’s decision to halt manufacture of heparin sodium in multiple-dose vials,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research. “FDA is vigorously investigating to determine the root cause of these serious reactions associated with the use of heparin made by Baxter. In the meantime, patients and health care professionals who cannot obtain alternative sources of heparin should use caution in administering any Baxter multiple-dose vials that remain.”

Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. In some situations, heparin treatment is initiated using a high bolus dose given directly into the bloodstream (intravenously) over a short period of time, usually less than one hour. The reported adverse events occurred in patients who were given heparin in this form of administration. There are many other uses of heparin involving lower doses or administration over a longer period of time; adverse events have not been seen with those uses.

About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007. Most of the events have taken place at hemodialysis centers, almost exclusively involving patients receiving a bolus dose – which is a high dose administered over a short time. While most of the reports involve multiple-dose vials, several cases include patients who received a bolus dose after their health care professional combined heparin from single-dose vials.

The Missouri Department of Health and Senior Services first notified the Centers for Disease Control and Prevention (CDC) in January of several severe allergic-type reactions to heparin that occurred at a single pediatric hospital beginning in November. The CDC in turn alerted FDA and Baxter, prompting the company’s voluntary recall of nine lots of heparin on Jan. 17.

Since then, FDA has learned of adverse events that extend beyond the recalled lots and involve patients receiving heparin for other purposes besides hemodialysis. Recent cases have included patients undergoing cardiac surgery and a specialized blood cell treatment known as photopheresis.

Over one million multiple-dose vials of heparin are sold per month in the United States; half of the vials are manufactured by Baxter of Deerfield, Ill. FDA is currently investigating whether similar events have been seen with other heparin manufacturers.

Physicians, dialysis center staff and health care providers are advised to use an alternate source of heparin or another blood-thinning drug when possible. When only Baxter product is available:

• Administer the heparin as an infusion (not a bolus) whenever possible.
• Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired clinical effect.
• Closely monitor the patient for adverse events, particularly hypotension and signs and symptoms of hypersensitivity and ensure that resuscitation equipment is available.
• Consider pretreatment with corticosteroids (cortisone type medicines) or antihistamines (drugs that relieve the symptoms of allergic reactions) although it is not known if such pretreatment is effective.

Any allergic-type reaction to heparin infusion should be reported to FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

SOURCE: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01797.html

SOURCE: Heparin Recall › Heparin Linked to Severe Allergic Reactions