Back in February, evidence surfaced that GlaxoSmithKline may have known all along that Avandia could cause heart problems. Now the FDA appears to be giving very serious consideration to forcing GSK to yank it from the market.
U.S. regulators are considering ending a safety study on GlaxoSmithKline's diabetes drug Avandia, the Wall Street Journal reported on Sunday, saying the move could also jeopardize the drug's presence in the U.S. market.
The WSJ story is behind a subscription wall, but the WSJ's Katherine Hobson blogged that given the clear link between Avandia and increased heart attacks, scientists think it's unethical to put study participants at risk. If the trial is killed off, Hobson writes, the FDA will consider forcing Avandia to stop selling the drug.
The FDA might have been prodded by a move from Saudi Arabia. Back in March, it barred sales of Avandia for at least six months. Shortly after that, FDA commissioner Margaret Hamburg wrote Chuck Grassley saying that the FDA is reassessing whether to let the trial go forward. Grassley coauthored a Senate Finance Committee report that found GSK may have hidden details of Avandia's heart risks.
Avandia has already gotten a de facto kiss of death from doctors. As we learned back in February, most doctors aren't even prescribing it anymore.