Avandia Safety Hearing Set for Next Week

The Food and Drug Administration will hold hearings in Washington beginning next Wednesday concerning the safety and effectiveness of GlaxoSmithKline’s diabetes drug Avandia. It is not clear if the federal agency is inclined to remove the drug from the market after some research has shown the drug to significantly increase the risk of heart attacks. Other research has called into question the drug’s effectiveness in comparison with similar drugs on the market.
“There is not complete unanimity within the FDA about the interpretation of these data,” Dr. Janet Woodcock, head of the FDA’s drugs center, told reporters on Thursday.
Issues with the drug’s safety began when a 2007 Cleveland Clinic study found that the diabetes drug was associated with a higher heart attack risk in Avandia users.
After hearing expert testimony, the FDA has several options which it will consider: a)removing Avandia from the market, b)restricting its use, c)adding stronger warnings, or d)removing the heart attack warnings altogether. The last option seems the least likely given the controversy over the drug and the influence of those researchers clamoring for the drug’s removal.
Avandia Class Action Lawsuit