FDA Issues Public Health Advisory for Popular Drug: Heparin

Baxter Healthcare Corporation has temporarily stopped producing multiple-dose vials of the injectable blood-thinning drug heparin. The U.S. Food and Drug Administration (FDA) issued a Public Health Advisory warning that patients receiving a high bolus dose injection of the drug have experienced serious allergic reactions and low blood pressure that is yet, unexplained. Most recent allergic reactions to heparin have occurred within minutes of the injection, but longer reaction times could occur.

Over 350 reports have been made regarding the Baxter heparin product since the end of last year. This compares to only 100 reports in all of year 2007. Four people have died since reports of the adverse affects were reported, but the relationship to heparin has not been established. Serious allergic reactions that have been reported include rapidly falling blood pressure that can lead to life-threatening shock, difficulty breathing, nausea and vomiting, oral swelling, and excessive sweating.

Heparin is made from pig intestines and has been marketed in the U.S. since the 1930's. Now, over one million multiple-dose vials are sold each month in the U.S. Baxter Healthcare Corporation manufactures half of those vials. It has not yet been determined if the serious allergic reactions are also being caused by other makers of heparin. Many patients use heparin to avoid complications from blood clots forming in veins, arteries, and the lungs. Others use heparin for treatment before or after coronary artery bypass graft surgery and kidney dialysis. More recent cases of allergic reactions occurred in patients who used heparin during cardiac surgery or photopheresis, which is a blood cell treatment.

The serious adverse affects of heparin were reported in patients who received large doses injected directly into the bloodstream during a short period of time, usually within an hour. In November of 2007, several cases of serious reactions were reported by a single pediatric hospital in Missouri, which reported the cases to the Centers for Disease Control and Prevention (CDC). Most cases have been reported from hemodialysis centers around the country. Some of the cases were reported in patients who received bolus doses after the health care staff administered combined single vials of heparin.

The FDA recommends that health care providers look for other manufacturers of heparin to meet patients' needs. More suggestions for administering heparin are available at the FDA website if an alternative to the Baxter heparin product is not available. Health care providers and patients should report any allergic-type reaction to heparin infusion to FDA's MedWatch on line at http://www.fda.gov/medwatch/report/hcp.htm, by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.

Sources:

http://www.fda.gov/cder/drug/advisory/heparin.htm

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01797.html