Contaminated Heparin Rocks Consumer Confidence

Have you ever heard of the drug Heparin? If you take blood thinner medication, you may be familiar with this prescription – even if it’s not the particular one you take. If you don’t happen to take heparin, you can thank your lucky stars. A batch of contaminated heparin has been linked to 81 deaths in the U.S. alone, according to the FDA. Keep reading for more information on this potential health threat.

Have you ever heard of the drug Heparin? If you take blood thinner medication, you may be familiar with this prescription – even if it’s not the particular one you take. If you don’t happen to take heparin, you can thank your lucky stars. If you do take heparin, you definitely want to keep reading.

The deadly affects of contaminated heparin
Relatives of people who died after being injected with contaminated heparin gave emotional testimony before a congressional subcommittee on April 30, 2008. Family members expressed outrage and grief at the failure of the government and the drug’s manufacturer to ensure the drug’s safety.

In an article at CNN.com, dated April 30, Mrs. Colleen Hubley of Toledo, Ohio was quoted as telling the subcommittee “I watched my husband and best friend slip away before my eyes. My husband was a fighter to the bitter end. I know he would want me to make sure this doesn’t happen to anyone else.” Mrs. Hubley, a dialysis nurse, said she felt competent to handle any issues her husband might have encountered as he underwent dialysis. She was frantically performing CPR on her husband when he died in January.

Sadly, this is one of many heartbreaking stories heard by the subcommittee. Shipments of contaminated heparin (a blood thinner) have been traced from China to eleven countries, including the United States. Investigators have identified oversulfated chondroitin sulfate (OSCS) – a mixture made from animal cartilage – as a contaminant linked to hundreds of serious adverse events. Allergic reactions causing nausea, vomiting, a severe drop in blood pressure and shortness of breath were all traced back to the contaminant.

How the product became contaminated is still unknown. Dr. Janet Woodcock, Director or the FDA’s Center for Drug Evaluation and Research said, “The FDA’s working hypothesis is that this was intentional contamination, but this is not yet proven.”

Eighty-one deaths related to those symptoms have now occurred in the United States, according to the Food and Drug Administration, though China disputes there is any link. Woodcock stated last week the most severe reactions seem to be more likely among patients given high dosages of the drug.

The basic, raw ingredient for heparin sold by Baxter International and recalled, came from a laboratory in Wisconsin which also owns a Chinese factory where the heparin was being processed.

Who is to blame?
Last week the FDA sent Changzhou SPL (the Chinese factory) a stern warning letter insisting the company had not used proper safeguards when processing the drug.  The letter also stated shipments of the company’s products made at the plant would be refused admission into the United States until the matter is corrected.

Changzhou SPL was not the only one in hot water, however. Members of Congress blasted the FDA for approving the plant as a supplier of heparin without ever performing an inspection on it.  The FDA was not the only other entity singled out. Committee Chairman Bart Stupak also said “Make no mistake about it, both Baxter and SPL have failed the American public.”

Robert Parkinson, Jr. President and CEO of Baxter told the committee that his company had tested every lot of heparin it received from China. The problem, it seems, OSCS (a heparin-like contaminant) could not be detected with standard testing until recently.

The investigation continues, however, and the FDA assures U.S. consumers that all possible contaminated heparin has been taken out of circulation and the supply is once again safe.