Baxter Heparin problems have resulted in four deaths and hundreds serious reactions

By Harvey Kirk
Posted February 14, 2008

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Less than one month after Baxter issued a heparin recall for nine lots of their multi-dose heparin vials, the company has halted all production of the blood thinner. The FDA is investigating reports of widespread allergic-type reactions which have been associated with at least four deaths and hundreds of other serious heparin problems.

>>PRIOR POST (2/6/08):Heparin problems

Heparin is a blood thinner which is often used during kidney dialysis or during certain types of heart surgery to prevent blood clots. It is manufactured by extracting microbes and certain proteins from pig intestines through a purification process. The FDA is reviewing whether a manufacturing issue during the purification process has resulted in contamination of the heparin.

Although Baxter initially indicated that the heparin problems were limited to nine lots of the drug, the recall was expanded this week to result in the suspension of all production after the FDA received reports of about 350 heparin reactions over the past 45 days. This represented a drastic increase over prior reports, as there were less than 100 reported heparin adverse reactions during the entire year of 2007.

The FDA classified about 40% of the reported heparin problems as serious health concerns, and at least four people have died after receiving the injectable medication. Most of the reactions occurred within minutes after administration of the heparin, and early signs of problems could include:

• Nausea and vomiting
• Difficulty breathing
• Excessive sweating
• Decreased blood pressure
• Shock

The recall applies to Baxter Heparin Sodium Injection multidose vials (1,000 units/mL concentration, 10mL and 30mL vials; 5,000 units/mL concentration, 10mL vials; and 10,000 units/m, 4mL vials). The heparin problems only appear to be associated with the multidose vials, and Baxter is continuing to produce the single-dose vials.

Heparin is a critical medication, and many are concerned that the Baxter heparin problems could lead to a shortage of the drug. About half of all multi-dose vials of heparin sold in the United States are manufactured by Baxter, with about 100,000 vials sold each day. The remainder of the heparin supply in the United States mostly comes from APP Pharmaceuticals, who will be increasing their production of the drug to help avoid any severe shortage of the important drug.

BAXTER HEPARIN LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits on behalf of individuals who have experienced Baxter heparin problems. If you, a friend or family member have suffered a severe allergic-type reaction after receiving a heparin injection, request a free claim evaluation.