Some Medical Centers Still Stocking Contaminated Heparin, FDA Alert

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Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist
Article Date: 10 May 2008 - 3:00 PDT

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The US Food and Drug Administration (FDA) has found some hospitals and medical centers are still stocking potentially contaminated heparin among their supplies, showing that they failed to respond to recall notices and alerts about the blood thinner made by Baxter International.

A spokeswoman for the FDA said that medical facilities in California were sent a letter on 2nd May about gaps in the recall response, and when they followed up with a check, they found that "more than a handful of hospitals had not removed all contaminated heparin," reported the Wall Street Journal.

She said they found the product on "crash carts, catheter labs, and even on one hospital pharmacist's shelf".

Heparin is used in operating theatres and kidney dialysis centers to stop potentially fatal blood clots. The contaminated product, made by Baxter International, has been linked to severe allergic reactions and over 80 deaths, and investigations by the FDA, which are based on the results of several labs, suggest this may be due to a contaminant that has been found in raw ingredient supplied by a firm in China.

The FDA has issued reminders because there are gaps in the response to the alerts and recalls by the agency and the manufacturer, and also because of information from the California Department of Health.

The reminder, as reported by the Wall Street Journal, asks everyone to:

"Spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS)."

"Affected heparin products have been found in medical care facilities in one state since the recall announcement," said the FDA.

In the meantime, Chinese officials are denying that the oversulfated chondroitin sulfate contaminant is to blame for the deaths and has accused Baxter of obstructing their own investigation, according to a report from Reuters of a press conference given last Tuesday by Jin Shaohong, of China's National Institute for the Control of Pharmaceutical and Biological Products.

They said the adverse reactions and deaths have only been reported in the US and Germany, and other countries that have also found the contaminant in their heparin products have not reported any reactions.

The Chinese health authorities maintain that adverese reactions have also been linked to batches that did not contain the contaminant, based on their own tests. Earlier this month the FDA denied this was the case, because they and other labs had also tested these batches and found the contaminant.

The contaminant has the same proportions of chemical elements as heparin, and very sophisticated equipment using MRI is required to tell the difference between real heparin (which is made from pig intestines and expensive to source in China since an outbreak of pig disease) and the contaminant (which is made from much cheaper animal cartilage).

The Chinese authorities have accused Baxter of destroying samples and records that they considered key to their investigation, but according to Reuters, this was denied by a Baxter spokesperson based in China.

Click here for FDA "Information on Heparin Sodium Injection".

Sources: Wall Street Journal, Reuters, FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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