Print

Update: Increased Concern over Mounting Numbers of Reported Deaths and Serious Injuries Prompt the FDA to Order Testing of Medical Devices Containing Heparin

© Copyright 2008.  All rights reserved.

Last March, the FDA announced that it had 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]  When manufactured properly, heparin is derived from the mucous membranes of slaughtered pigs.  It appears that Baxter's manufacturing facilities (involving 12 different companies in China) had substituted oversulfated chondroitin sulfate (OSCS) made from animal cartilage and, in so doing, had created this public health disaster.  According to the FDA, tests on heparin batches from China have shown that the contaminant accounted for as much as 50% of the active ingredient!

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]  By April, 2008 the FDA had reported 131 deaths associated with this blood thinner since January 1, 2007.[1]heparin[9]  In fact, the FDA has also received reports of an additional 8 deaths and 97 reports of adverse events associated with heparin-containing devices that occurred between January 1, 2008 and May 14, 2008.

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]

Many medical devices utilize heparin coatings and, as a result, inadvertently create additional and otherwise avoidable risks to patients using those devices.  For that reason, on April 8, 2008 the FDA, Center for Devices and Radiological Health sent device manufacturers a letter notifying them of serious adverse events potentially related to contaminated heparin.  The FDA asked that all device manufacturers and initial distributors of heparin coating or coated products test their devices and products using FDA recommended test methods to assure that they are contaminant free.[2]  In fact, the FDA has received reports of an additional 8 deaths and 97 reports of adverse events associated with heparin-containing devices that occurred between January 1, 2008 and May 14, 2008.

In response to the FDA Notice, Medtronic Corporation has initiated a "voluntary and precautionary" recall of selected products featuring Carmeda BioActive surface (containing heparin).  This included the recall of disposable products used during cardiopulmonary bypass surgery for heart surgeries, including blood oxygenators, reservoirs, pumps, cannulae and tubing packs.  Following on this announcement, Atrium Medical Corp. has recently recalled its heparin-coated Hydraglide catheters stating that "while [they] do not contain high levels of heparin, there still exists a potential exposure of oversulfated chondroitin sulfate to the patient."

Heparin 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 us 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, available at http://www.fda.gov/oc/qanda/heparin.html
[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.


[1] FDA Information on Adverse Event Reports and Heparin updated as of April 28, 2008.  http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm

[2]   FDA Follow Up Notice to Heparin Device Manufacturers dated May 9, 2008.  http://www.fda.gov/cder/drug/infopage/heparin/

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.