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Updated Questions and Answers on Heparin Sodium Injection (Baxter)

Q. What has FDA recently announced about heparin?

A. Adverse events, including deaths, have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China. In February 2008, Baxter Healthcare Corporation recalled multi-dose and single-dose vials of heparin sodium for injection as well as HEP-LOCK heparin flush products. After launching a disciplined, methodical examination, FDA scientists have identified a previously unknown contaminant in the heparin. The agency does not have proof that this contaminant is causing the adverse events. There is an association, but not a direct causal link at this time. The agency has made available information on two tests that FDA scientists have conducted to detect the heparin-like substance, and recommend their use to manufacturers and suppliers for screening the heparin API.

Q. What steps has FDA taken?

A. Along with overseeing the recall, FDA scientists have

• Provided recommendations to health care professionals about strategies to limit the occurrence or severity of adverse reactions in cases where the use of heparin is medically necessary and Baxter heparin is the only heparin product available.
• Launched a far-ranging investigation in the United States and abroad.
• Inspected a New Jersey facility to find out whether the heparin could have been contaminated by its packaging.
• Traveled to China to perform a thorough check of the plant that manufactures the heparin ingredient.
• Notified FDA's key regulatory international partners.
• Worked closely with the manufacturer and experts in academia and private laboratories to carry out a thorough chemical analysis of the suspect products. The agency made available information on two tests that FDA scientists have conducted to detect the heparin-like substance, and recommended their use to manufacturers and suppliers for screening the heparin active pharmaceutical ingredient (API).
• Worked to ensure that there exists a safe and adequate supply of heparin to the U.S. market.

Q. What kind of testing did FDA scientists conduct?

A. After conventional testing did not prove useful in detecting these contaminants, FDA experts developed new test methods that use existing state-of-the-art technologies such as nuclear magnetic resonance, capillary electrophoresis, enzymatic kinetics, and bioassay.

Q. What were the results of the testing?

A. FDA scientists determined that the sampled products contained 5 percent to 20 percent of a heparin-like compound—a contaminant that mimicked heparin activity so closely that it was not recognized by routine testing.

Q. How did the contaminant get into the product?

A. At this point, FDA does not know how the contaminant got into the heparin active pharmaceutical ingredient (API). The agency is continuing to aggressively investigate the situation.

For More Information
Information on Heparin Sodium Injection (Baxter)

Date Posted: March 7, 2008

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