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Update: FDA Finds Contaminant In Heparin, Which Is Being Investigated for Severe Allergic Reactions and Death

Copyright 2008.  All rights reserved.  

Last week, the FDA announced they have found an "unknown contaminant" in the blood-thinning drug heparin that is produced by Baxter HealthCare Corporation.[1]  The FDA has found an association between the contaminant and the adverse events being reported with heparin.[2]  Of the heparin samples tested, the FDA determined that 5% to 20% of the samples contained the contaminant, which is a "heparin-like compound."[3]

Heparin sodium is an anticoagulant, commonly known as a blood thinner, which prevents blood clot formation and stops blood clots from growing larger.  It is frequently given intravenously to patients undergoing kidney dialysis and heart surgery and to treat or prevent other serious medical conditions, like deep venous thrombosis and pulmonary emboli. 

Recently, serious adverse events have been reported in patients who received heparin manufactured by Baxter HealthCare Corporation, a company that manufacturers about half of the heparin used in the United States[4] and sells about $30 million every year in the United States.[5] 

The adverse events usually occur very shortly after high-dose heparin therapy is given.[6]  These adverse events include severe allergic-type hypersensitivity reactions such as severe hypotension that may result in death.[7]  Other types of adverse reactions that have occurred include swelling, nausea, vomiting, sweating, shortness of breath.[8]  In fact, from mid-December 2007 through January 2008, over 350 adverse advents were reported with Baxter's heparin usage, including four deaths.[9]

Due to the large increase in reported adverse events, in January 2008, the FDA inspected Baxter's manufacturing plant in New Jersey, and Baxter decided to recall nine lots of their multiple-dose heparin vials.[10]  According to the FDA, reports of serious adverse events have continued to pour in, indicating that the adverse events were not limited to patients receiving only the recalled lots of heparin.[11]  Thus, Baxter announced on February 11, 2008 that it would suspend production of multiple-dose vials of heparin.[12]  On February 28, Baxter extended its recall on multi-dose heparin to include all lots of the multi-dose heparin, as well as single-dose heparin vials and heparin lock flush products.[13]

While the cause of the adverse events is currently unknown, the investigation into heparin is now focused on whether the raw material for the drug, which is made from pig intestines and manufactured in China, was contaminated.[14]  The underlying cause of the adverse events remains under investigation.[15]

Attorneys at Robins, Kaplan, Miller & Ciresi L.L.P. are currently investigating claims related to heparin.  If you or someone you know has been injured or killed following use of heparin and you wish to consult with a lawyer, please call Kate Jaycox at 612-349-8452.  You can also reach Kate toll-free at 1-800-553-9910, or by e-mail by clicking on this link: contact us.  



[1] Updated Questions and Answers on Heparin Sodium Injection, March 7, 2008
[2] Id.
[3] Id.
[4] FDA Public Health Advisory: Important Warnings and Instructions for Heparin Sodium Injection (Baxter), Feb. 11, 2008, available at http://www.fda.gov/cder/drug/advisory/heparin.htm.
[5] Baxter Provides Update on Heparin Reactions, available at http://www.baxter.com/about_baxter/news_room/news_releases/2008/02-11-08-heprin_update.html.
[6] FDA Public Health Advisory: Important Warnings and Instructions for Heparin Sodium Injection (Baxter), Feb. 11, 2008, available at http://www.fda.gov/cder/drug/advisory/heparin.htm.
[7] Id.
[8] Id.
[9] Id.
[10] Id.
[11] Id.
[12] Baxter Provides Update on Heparin Reactions, available at http://www.baxter.com/about_baxter/news_room/news_releases/2008/02-11-08-heprin_update.html.
[13] FDA Public Health Update: Recall of Heparin Sodium Injection and Heparin Flush Lock Solution (Baxter), Feb. 28, 2008, available at http://www.fda.gov/cder/drug/infopage/heparin/public_health_update.htm; News Release: Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products, Feb. 28, 2008, available at http://www.baxter.com/about_baxter/news_room/news_releases/2008/02-28-08-heparin.html.
[14] David Barboza and Walt Bogdanich, Twists in Chain of Supplies for Blood Drug, The New York Times, Feb. 28, 2008.
[15] FDA Public Health Update: Recall of Heparin Sodium Injection and Heparin Flush Lock Solution (Baxter), Feb. 28, 2008, available at http://www.fda.gov/cder/drug/infopage/heparin/public_health_update.htm.

 

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