FDA Adds Warning of Celgene’s Risks for Elderly

Beth Janicek

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Celgene Corp. added an additional warning to its blood-clot drug Innohep stating that it could increase the risk of death in elderly patients with kidney problems. Innohep (tinzaparin) is a low-molecular weight heparin used as a blood thinner or anti-coagulant approved in 2000 by the FDA to treat blood clots in patients with pulmonary embolism (PE) and deep vein thrombosis (DVT).

As of October 15, 2008, the FDA had received 383 reports of side effects and complications worldwide, including 96 deaths. The company stated that the risk only appeared for elderly patients age 90 and older, but the FDA asked Celgene to further revise the warning to include elderly patients 70 and older. Celgene posted a letter that says,

“We now regard the risks for Innohep as applying to all elderly patients with renal insufficiency and have further revised the label to include this information as a warning.”

Preliminary data does not appear to indicate a manufacturing problem with Innohep, but the FDA cannot categorically rule out this possibility until a thorough analysis of the manufacturing data is completed. Information surrounding the side effects will be evaluated to determine whether Celgene will be held liable for failing to provide adequate warnings about the risk of death.

If you or a loved one have had complications or have experienced any negative side effects due to the mistaken subscription of medicine such as Innohep contact a personal injury attorney.