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Home » Hot Topics » Heparin Recall » FDA Now Able To Link Heparin Lots to Deaths

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Article: FDA Now Able To Link Heparin Lots to Deaths

The U.S. Food & Drug Administration (FDA) announced that after months of research, it can conclusively link specific lots of heparin to some of the deaths that were reported earlier this year.

Heparin: What happened?

Heparin, the blood thinning drug that is essentially derived from pig intestines, has been linked to 93 deaths in the United States and over a thousand injuries after it was discovered that the drug was contaminated with animal-like substance known as oversulfated chondroitin sulfate (OCS). OCS is much less expensive to produce, but was thought to be the cause of many of the reported deaths. However, that could never be substantiated – until now.

New information

According to the FDA (www.fda.gov/), it reviewed the 93 death cases that were reported from January 1st to March 31st 2008 allegedly due to heparin contamination. It concluded that of the ten deaths caused by hypotension, three of those could be directly linked to certain lot numbers of heparin placed into the U.S. market by Baxter International who recalled all lots of its heparin earlier this year. Baxter purchased the raw ingredients from Scientific Protein Laboratories, who received those ingredients from a Chinese factory.

The FDA stated that the other seven deaths caused by hypotension could not be associated with a specific lot of the drug. The Administration also reported that of the remaining 83 deaths, 13 cases have been described as “potential complications of heparin use”, 25 cases have been associated with causes unrelated to heparin use such as renal (kidney) failure, pneumonia and sepsis and 45 cases did have enough information to identify a cause.

There are still thousands of injuries that are being linked to contaminated heparin in the United States, not only due to heparin distributed by Baxter, but other manufacturers as well.

Which manufacturers recalled heparin?

Several manufactures, in addition to Baxter, recalled heparin earlier this year. Those include Covidian, B. Braun Medical, American Health Packaging and AM2 PAT.

If you have suffered injuries that may have been the result of heparin use, it’s important to contact an attorney as soon as possible. Depending upon which state you live in, the statute of limitations may have already started to run. Don’t risk losing out on compensation for which you may be entitled.

To contact an experienced attorney whose practice focuses in this area of the law, please click here. Consultations are without obligation, free and strictly confidential.

Articles & Information:

AM2 PAT, Inc. Recalls Heparin and Normal Saline Pre-Filled Flushes

Baxter Healthcare Recalls 9 Lots of Heparin

Baxter’s Heparin Issues Continue: FDA Admits Never Inspecting Chinese Manufacturer

Where Raw Heparin Comes From: A Picture Is Worth a 1,000 Words

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