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Who should be concerned with Heparin?

By Steve Lombardi

It's being reported that US deaths from Heparin continue to climb. It's worth revisiting this subject to warn who should be concerned about this issue. If you don't know what Heparin is used for or want general information concerning the drug go to the InjuryBoard link or the Jane Akre's discussion. She's done a very good job of boiling the controversy down to its essence.

But that won't answer how to protect you. You'll need to visit the FDA site to get further detailed information. The FDA reports that most of the reported adverse reactions have occurred for kidney dialysis patients. If you are a kidney dialysis patient you'll need to discuss the use of Heparin and other alternative drugs with your doctor.

Most of the cases took place at kidney dialysis centers. Other cases have included patients undergoing heart surgery or a specialized blood cell treatment called photopheresis. WebMd

Here is a synopsis of what you need to know and where to read further.

InjuryBoard - General Description

Heparin sodium is an injectable anticoagulant used to prevent blood from clotting in people who are undergoing certain medical procedures. Heparin is derived from cells in raw pig intestine, and is manufactured by Baxter Healthcare and APP Pharmaceuticals in the United States. Heparin is also used to prevent blood clots from forming in catheters that are left in veins over time. The pharmaceutical ingredient works by decreasing the clotting ability of the blood, and is a vital element for patients undergoing kidney dialysis.

Jane Akre for InjuryBoard

FDA officials say they've identified the contaminant found on recalled batches of heparin - over-sulfated chondroitin sulfate.

It mimics the blood-thinning abilities of heparin and can be obtained from animal sources other than pig intestines where heparin is sourced.

It is commonly sold over-the-counter as a joint pain dietary supplement, more often known as chondroitin.

Over-sulfated indicates it was man-man as this doesn't occur naturally, the FDA's Dr. Janet Woodcock told reporters in a conference call. 

Was it intentionally or inadvertently added during manufacturing at the Chinese plant?  In some cases it was found in two to up to 50 percent of the recalled heparin samples.

WebMD

 Serious reactions to Baxter's heparin bolus doses have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock.

It's not clear if the drug caused any of the four deaths, notes John Jenkins, MD, director of the FDA's Office of New Drugs.

Since late December, the FDA and Baxter have received "approximately 350 adverse event reports, and approximately 40% of those reports have been characterized as serious," Jenkins said at a news conference.

Most of the cases took place at kidney dialysis centers. Other cases have included patients undergoing heart surgery or a specialized blood cell treatment called photopheresis.

 FDA Notices

Updated Questions and Answers on Heparin Sodium Injection (Baxter) - 3/7/2008

Information on Heparin Sodium Injection

Questions and Answers on Heparin Sodium Injection (Baxter) - 2/11/2008

 

 

Originally posted at InjuryBoard by Steve Lombardi

Full post as published by Des Moines Personal Injury Lawyer on May 22, 2008 (boomark / email).