Bian Zhenijia, director of the drug safety supervision department of the State Food and Drug Administration (SFDA), urged companies to be more responsible when dealing with foreign suppliers.

“The problem lies in the fact that some overseas companies have an implicit deal with underground factories or illegal manufacturers in China, so the product involved has problems,” Bian said at a press conference.

China’s pharmaceutical industry is poorly regulated and several deaths and illnesses have been blamed on contaminated medications produced there. Last year, heparin manufactured in China was linked to more than 80 deaths and hundreds of illnesses in the United States. The blood thinner was later found to have been contaminated with a heparin-mimicking substance called oversulfated chondroitin sulfate, or OSCS. Heparin is derived from pig intestines, which are often produced by unregistered China businesses.

“I do not agree with what the foreign media say. The Chinese government has always paid a lot of attention to cracking down on fake drugs,” Bian told a news conference. “If the international community can give us information on fake drugs, we will resolutely investigate. There is no ambiguity about this.”

More than 300,000 cases of unlicensed drugs and medical products were distributed in 2007, according to SFDA.

Sources:
Associated Press
Reuters

SOURCE: Heparin Recall › China says tainted drug blame should fall on foreign suppliers

Anticoagulants are often administered to patients before undergoing some surgeries and medical procedures to reduce the risk of life-threatening blood clots. Lovenox has been touted as an effective replacement for the blood thinner heparin in patients undergoing abdominal surgery.

Heparin carries a laundry list of side effects such as nausea, vomiting, abdominal pain, diarrhea and low blood pressure. Concerns about heparin flooded the media last year with cases of accidental overdoes and shipments of tainted batches of the blood thinner imported from China. Both incidences caused patients serious injury or death.

The contaminated heparin scandal in particular created an urgency among consumers, the medical community and pharmaceutical companies to find safer alternatives to the commonly used blood thinner.

Momenta chief executive officer Craig A. Wheeler said in the conference call that the FDA continues to review its Abbreviated New Drug Application (ANDA) process for M-Enoxaprin. ANDA is the FDA’s Center for Drug Evaluation and Research Office of Generic Drugs review and ultimate approval process of a generic drug.

Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. “We are in regular communication with the agency and responding to their questions as they arise,” Wheeler said.

Wheeler referred to the “global contamination issue” with the heparin supply and the FDA’s plant inspections of Chinese suppliers of heparin, adding that the companies who supply heparin to Momenta’s partner distributor Sandoz for the manufacture of M-Enoxaprin have all been inspected by the FDA.

While the company has no indication that the inspections raised concerns with the FDA, Wheeler said “Any disruption in the heparin supply has the potential to impact our supply chain.” As a result, the company will diversify its sources of heparin and closely monitor the supply chain.

Momenta hopes to launch M-Enoxaparin in 2009 provided the ANDA is readily approved by the FDA.

Source:
Seeking Alpha

SOURCE: Heparin Recall › FDA approval for marketing generic Lovenox expected

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

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

Researchers identified the contaminant last April and noted how it could lead to severe allergic reactions. This new MIT report documents the reactions and specifically links them to batches of heparin that were manufactured in Baxter International’s Chinese facility. The findings were published in the New England Journal of Medicine.

In an effort to provide guidance on U.S. quality standards and avoid life-threatening contaminations of drugs imported into the U.S., the FDA has begun setting up foreign offices and placing more than 60 food and drug regulators worldwide. Last month, the agency opened its first foreign offices. Three of those first offices were located in China.

Health and Human Services Secretary Michael Leavitt said the foreign offices will send a clear message to producers that if they want access to the American market, they must make products that meet a higher standard of quality.

SOURCE: Heparin Recall › MIT report proves type of contaminant in Chinese heparin

This new method is easier and less expensive than analytical methods used previously, such as nuclear magnetic resonance and capillary electrophoresis. Meyerhoff and his team detailed the research in the journal of Analytical Chemistry.

Oversulfated chondroitin sulfate in batches of heparin manufactured in China were responsible for serious allergic reactions that earlier this year killed more than 80 Americans and made thousands more ill.

Heparin was only one of the many products made in China in the past several months was were found to be unsafe for humans and animals. As a result, the FDA vowed to place more than 60 food and drug regulators worldwide over the next year as opposed to sending staffers on individual assignments to inspect foreign facilities. The agency’s first office opened in Beijing Wednesday. Additional Chinese outposts will open in the next few days in Shanghi and Guangzhou.

Earlier this week, HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach joined China’s minister of health, Chen Zhu, in a workshop on food safety that focused on policy and government reforms, according to a CNN story about the opening of the Beijing office.

“The government should not just respond to the incident but find the root of it,” CNN quoted Chen in a news conference Wednesday in Beijing.

SOURCE: Heparin Recall › Researchers find new method to detect contaminant in heparin

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

The active ingredient in heparin is derived from pig intestines and the demand for the drug has become so great that the domestic pig population cannot meet the demand. To meet the immediate need, pharmaceutical companies have turned to China, which has three times the pig population.

But importing drugs from China has raised some serious concerns. Earlier this year, 81 people died and hundreds more were sickened after receiving doses of heparin, which was later found to have been contaminated in a Chinese manufacturing plant.

As a result, scientists are eagerly working to develop a synthetic version of heparin that could be made in U.S. labs, thus preventing future scares. In August, we told you about Rensselaer Polytechnic Institute’s Robert Linhardt, who had just announced that after years of work his research team appeared to have successfully devised a synthetic heparin.

Linhardt and his team continue to forge ahead with the synthetic drug, according to the Scientific American. The challenge, however, is that it is hard to mass produce. It took a year for Linhardt and his team to produce 100 milligrams of the synthetic version, which pales in comparison to the more than 100 metric tons of heparin needed to meet the world’s demand for just one year.

Linhardt hopes to have a gram of synthetic heparin – or enough to give 100 doses to mice to start animal trials – within a year. Far more of the synthetic drug would be needed for clinical testing on patients, presenting a further challenge. Cost could become another issue, as heparin made from pig intestines costs only about 20 cents per dose and making the synthetic version a feasible business would take years and a huge investment.

However, Linhardt says mass production of the synthetic heparin would have benefits that far outweigh the negatives: “The future is one that will be short continuously of heparin,” he was quoted in Scientific American. “Which means any adulterations of the heparin (imported by the U.S.), we’re going to have to live with—or catch.”

SOURCE: Heparin Recall › Scientists work to overcome obstacles in synthetic heparin

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

The report revealed that inspecting the more than 3,000 overseas drug plants would take the FDA more than 13 years to complete The agency fired back, saying “The conclusion that FDA should endeavor to conduct foreign inspections based on the same criteria as domestic inspections is…problematic because of the differences in regulatory methodology and resources,” according to the Associated Press.

The need for careful inspections of foreign drug manufacturing plants has come to the forefront since the tainted heparin scare earlier this year that killed more than 80 people and sickened hundreds more. Those batches of heparin were found to have been contaminated in Baxter International’s Chinese manufacturing plant.

Now the Natural News is reporting that the FDA is refusing to release information on which Chinese companies supplied the tainted heparin. According to Natural News, the FDA claims that a confidentially agreements with producers of heparin are preventing the government agency from revealing which Chinese companies supplied heparin ingredients to the United States. It also claims that because of the Memorandum of Agreement that regulates relationships between the FDA and China, the FDA does not have the legal authority to prevent Chinese-manufactured medicines from being imported into the U.S. The FDA says it relies on companies to voluntarily rest their own heparin ingredients, a process that obviously failed last year when contaminated heparin entered the United States.

Meanwhile, Chinese health officials say that it has not been proven that the heparin was contaminated in Chinese plants, and that contamination could just have easily happened in Baxter’s New Jersey plant.

SOURCE: Heparin Recall › FDA will not name Chinese plants that supplied tainted heparin

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

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

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