Heparin is a widely used blood thinner used to treat and prevent blood clots. In March 2008, major recalls of heparin were announced due to severe adverse reactions and deaths from lots manufactured in a China facility that a Food and Drug Administration (FDA) investigation revealed were contaminated with OSCS. The FDA later admitted that it was lax in its responsibilities to inspect overseas drug plants before approval drugs for sale.

Though no adverse reactions have been reported to B. Braun and the manufacturer does not believe the drugs pose a significant health risk, customers who have the recalled lots heparin in their possession are urged to discontinue use immediately. B. Braun is also arranging for return of all recalled products. Customers can direct questions to B. Braun at 800-227-2863.

Patients who are or have been using this product and have experienced any problems should contact their physicians. Any side effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

SOURCE: Heparin Recall › Tainted lots of heparin recalled

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

All three incidences occurred at the Beebe Medical Center in Lewes, Delaware, and all three were given heparin supplied by Baxter, the same drug company at the center of last year’s contaminated heparin scandal. That heparin, which killed more than 80 people and injured hundreds more, was manufactured in China. The latest batch was manufactured in Ohio.

The heparin in question involves premixed intravenous bags of heparin whereas the previous heparin, which was later found to have been contaminated with a heparin-mimicing substance called over-sulfated chondroitin sulfate (OSCS), involved vials of the medicine and drug-coated medical devices.

The symptoms suffered from the newest victims involved intracranial bleeding; the previous deaths and illnesses were caused by severely low blood pressure. Immediately following the adverse reactions, the hospital contacted Baxter, which immediately contacted the FDA.

Both Baxter and the FDA sent medical teams to Delaware and the FDA took samples of the heparin for testing. “As far as we can determine at this point, it appears to be an isolated incident,” says FDA spokewoman Karen Riley.

Baxter has tested for but not found the contaminant OSCS to be in the batches of heparin taken from Beebe Medical Center. Baxter insists the heparin used on the patients who became ill at Beebe was not manufactured in China but in North America.

SOURCE: Heparin Recall › New deaths, illness following heparin use spark FDA investigation

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

The label changes include modifications to the Warnings, Precautions and Adverse Reactions sections of Heparin Sodium in 5% Dextrose Injection and Heparin Sodium in 0.9 % Sodium Chloride Injection.

The labeling changes in part were spurred by the much-publicized overdosing of actor Dennis Quaid’s newborn twins, who nearly died in 2007 when they were accidentally given 1,000 times the intended dose of the blood thinner. The Quaid’s case is just one of many cases where health care workers claimed to have confused high-dose and low-dose heparin. Some argue that the two bottles can be easily confused.

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-threatening bleeding or hemorrhages, including in the brain.

Heparin has seen its fair share of the spotlight lately. Last 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 oversulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death.

SOURCE: Heparin Recall › FDA announces labeling changes for heparin

Rivaroxaban, a pill marketed in Europe as Xarelto, showed to be more effective than the anticoagulant heparin, while presenting no more side effects than heparin. Side effects of heparin and rivaroxaban include the risk of internal bleeding. Another benefit of rivaroxaban is that it does not need constant monitoring like another popular blood thinner, warfarin. Heparin is administered intravenously while warfarin is a pill taken orally.

Pharmaceutical companies have long been working on safer and easier alternatives to heparin and warfarin, especially since the tainted heparin scandal last year where more than 80 Americans died and hundreds more were made sick after receiving injections of batches of heparin that had been laced with oversulfated chondroitin sulfate (OSCS), a contaminant that mimics heparin but can cause serious allergic reactions in humans.

The FDA is expected to make a decision whether to approve rivaroxaban by May 28. If approved, rivaroxaban would be the first oral blood thinner approved since the FDA approved warfarin in 1954, according to Forbes.

“We appreciate the thoroughness of the advisory committee’s review, and we will continue to work with the FDA as they finalize their review,” Dr. Peter DiBattiste, vice president of Johnson & Johnson Pharmaceutical Research and Development, said in a prepared statement.

SOURCE: Heparin Recall › FDA panel recommends agency approval of heparin alternative

Sharfstein made headlines in 2007 when he convinced the FDA to restrict the use of over-the-counter children’s cough and cold medicines based on evidence they can cause serious health complications and even death in children.

If there is one government agency that needs overhauling, it is clearly the FDA. The agency has been under scrutiny for the past few years over contaminated food and drug products that have harmed and even killed Americans.

The agency is still feeling the repercussions from the tainted heparin scandal. Last year more than 80 Americans died and several more were made seriously ill after receiving injections of specific batches of the blood thinner that had been manufactured in a China plant. Those batches were found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a contaminant that mimics heparin but can cause serious allergic reactions.

Following the revelation, the FDA admitted that it simply did not have manpower to properly inspect foreign food and drug manufacturing plants. Since then the FDA has taken measures to step up its inspections by opening field offices overseas. The first three offices opened late last year in China.

The FDA employs more than 11,000 employees and an annual operating budget of $2 billion.

SOURCE: Heparin Recall › Hamburg, Sharfstein to head troubled FDA

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

The new standards were proposed by scientists with U.S. Pharmacopeia, a nonprofit public health group that sets standards for the quality, purity, strength and consistency of medicines. A spokesperson with the group says the new standards are the best as scientifically possible at this time.

The revisions for testing the popular blood thinner were first requested by the FDA when the contaminant was identified in March. The changes are expected to go into effect on August 1 and include three identification tests and screening for organic impurities.

Baxter was one of the leading manufactures of heparin, producing half of the injectable heparin sold in the U.S. and generating about $30 million in sales each year. Baxter stopped sales of heparin last year and has yet to resume selling the anti-coagulant. The company is facing numerous lawsuits from families affected by the tainted heparin.

SOURCE: Heparin Recall › Scientists propose new testing standards for heparin

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

Such is the case with the blood thinner heparin, which last year was the focus of much scrutiny when 80 Americans died and hundreds more were sickened after receiving doses of heparin manufactured in China. An investigation found that batches of heparin manufactured in Baxter International’s China plant had been contaminated with oversulfated chondroitin sulfate (OSCS). OSCS mimics the appearance of heparin but cause adverse reactions and even death.

Years ago most drugs were manufactured in the U.S., but over the years those operations have moved overseas – in particular, to Asia – where labor, construction, regulatory and environmental costs are lower. The FDA also inspects domestic plants far more often than foreign ones, which also adds to pharmaceutical companies’ production costs.

Following the heparin contamination last year, the FDA admitted that it was not sufficiently staffed to inspect all foreign offices. Thus, the agency has since begun to set up offices in foreign countries. To date, offices have been placed in China and India. The FDA also launched a voluntary two-year “Secure Supply Chain” pilot project to help promote the safety of drugs and active drug ingredients made outside the U.S.

SOURCE: Heparin Recall › Lawmakers call for rule requiring drugs be made in U.S.

Last year the FDA announced it would place more than 60 food and drug regulators worldwide in an effort to keep unsafe drugs out of the country. Late last year the first offices opened in China, a country whose products have made headlines over the past several months for harming hundreds of thousands of people around the globe.

Aside from lead paint on toys, faulty cribs, tainted pet food and contaminated milk, China was also the site where investigators found a drug manufacturing company had contaminated batches of the blood thinner heparin with oversulfated chondroitin sulfate (OSCS). OSCS mimics the appearance of heparin but can cause adverse reactions and even death.

Before the contaminate was detected, the OSCS-laced heparin was imported into the United States, where it was administered to patients. The tainted heparin killed more than 80 people and sickened hundreds more.

The FDA reports that India is the fourth largest exporter of drugs and biologics into the U.S., according to Med Page Today.

The FDA also announced last week that it will launch a voluntary two-year “Secure Supply Chain” pilot project to help promote the safety of drugs and active drug ingredients made outside the U.S. 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.

SOURCE: Heparin Recall › FDA opens offices in India to help oversee drug importation

The study also reported, “the use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions (present in 100 percent of case facilities vs. 4.3 percent of control facilities).” Those facilities included 21 dialysis facilities that reported reactions and 23 facilities that had no reported reactions. Adverse reactions reported included hypotension, nausea and shortness of breath. Most symptoms presented within 30 minutes of administering the drug.

All of the facilities that reported adverse reactions had vials of heparin manufactured by Baxter Healthcare that were contaminated with OSCS, according to the report. Researchers found that of the 130 reactions for which information on the heparin was available, more than 98 percent occurred in a facility that had OSCS-laced heparin on premises. Of the 54 reactions for which the lot number was known, the report shows that 96.3 percent occurred after the patients received the OSCS-tainted heparin.

According to the report, “Heparin contaminated with OSCS was epidemiologically linked to adverse reactions in this nationwide outbreak. The reported clinical features of many of the cases further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak.”

SOURCE: Heparin Recall › CDC study provides details on OSCS-laced heparin

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