Product Liabilty: FDA Requires New Warning For Avandia

Scott Barber

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The FDA has required GlaxoSmithKline to place a "black box" warning on its Diabetes drug, Avandia. The warning requirement is based upon 42 studies which show an increased risk of heart attack or chest pain associated with the use of Avandia. A May 21 report in the New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attacks. Avandia was the world's best-selling diabetes drug last year.

Glaxo has agreed to the FDA's request to conduct a new trial of Avandia. This time Avandia will be compared directly with Actos and perhaps other diabetes drugs. The drug trial will start next November and last four to five years with the results available in 2014. Iinterim analyses of the data should provide the agency and doctors with some earlier guidance on the drug's safety.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.