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Complete Warnings Are a Pharmaceutical Necessity


Complete Warnings Are a Pharmaceutical Necessity

May 31, 2012

In 2010 the anticoagulant drug Pradaxa, otherwise known as dabigatran etexilate mesylate, was approved by the FDA and introduced to the US market, offering consumers a replacement to existing versions of blood thinning drugs such as Coumadin. Since Pradaxa’s release several dozen consumers from Tennessee, Louisiana, Kentucky, and Connecticut have filed lawsuits alleging injury from the use of the drug, claiming the manufacturer failed to adequately warn consumers of the possibility of the irreversibility of the drugs anticoagulation effects.

As of December 2011, the FDA reportedly received over 500 reports of death in the US claimed to be linked to Pradaxa. Despite the product being on the market since late 2010, the manufacturer did not modify its labeling to include warnings of risk of bleeding until January 2012. According to the Court filings, in 14 months on the US market the drug was linked to approximately 1400 instances of gastrointestinal hemorrhages, rectal hemorrhages and cerebrovascular incidents.

It is imperative for a pharmaceutical manufacturer to list complete and adequate warnings regarding all potential side effects and reactions a consumer may experience with use of its product, to minimize risk and avoid unnecessary legal expense. Manufacturers should consult counsel in advance of a pharmaceutical release to ensure a product’s warnings are adequate and in compliance with FDA regulations.

For more information, please contact any member of the Global Insurance Services Practice Group.