Schedule a Consultation | Toll Free: 1-800-678-1307
Trial lawyers specializing in personal injury and civil litigation

Food and Drug Administration votes to restrict sales of Avandia

On July 14, the 33 members of the FDA Advisory panel voted to restrict the sale of what was once the biggest selling diabetes drug in the world.  Avandia is used to lower circulating blood sugar.  12 members of the panel--composed of doctors and representatives of drug manufacturers--would have removed the drug from the market.  The FDA will now have to decide how to respond to the vote.  This vote and the FDA's actions will likely be heavily influenced by recent disclosure of internal GlaxoSmithKline documents showing that the company hid from regulators internal data that called into question the safety of the drug.  Dr. Steven Nissen of the Cleveland Clinic published a study in 2007 which documented the increased risk of heart attacks associated with the drug.  He hoped that the recent vote means "effectively this drug is gone."  Others suggest that at a minimum, it should become a second-line treatment, rather than the first option for diabetics.  The manufacturer pleaded for time to conduct a new safety study, however, the majority of the advisory panel apparently concluded that GSK could not be trusted and had mis-used the time allowed under a 2007 vote to allow continued sales.  Panel members suggested that the 2007 vote had been conditioned on further study by the manufacturer.
Thompson O’Neil, P.C.
309 East Front Street
Traverse City, Michigan 49684
Toll Free: 1-800-678-1307
Fax: 231-929-7262