Avandia Should Remain Available: FDA Official
On December 4, 2008, a top level FDA official said GlaxoSmithKline PLC’s diabetes drug Avandia should remain available to patients despite some medical associations’ calls for doctors not to use it.
Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, said in an interview that people have “convicted” Avandia “without a trial.” The drug, which helps lower glucose levels in diabetics, has been associated to a higher rate of cardiovascular events including heart disease.
Dr. Woodcock noted that the drug now carries a black-box warning. “Nobody wants to be harmed,” she said, but “patients need to have treatment, so we have to look at the values of the patients.” She said patients and their doctors are best at determining the level of risk they are willing to take.
The American Diabetes Association and its European counterpart have told doctors not to use Avandia.
GlaxoSmithKline has said the drug is safe and effective when used according to its label.
