Is Avandia the new Vioxx?

New analyses are showing that Avandia, the diabetes drug, has been implicated in a large number of heart attacks, strokes and deaths. It is still on the market years after serious questions were raised. In mid-July the FDA will have a meeting to decide whether to let it remain available.

If Avandia were spinach, peanut butter or meat, the FDA would have been recalled it years ago. But being a drug it is subject to a much more lax recall standard.

here are some story excerpts from NPR

..The study looks at what happened when nearly 230,000 Medicare recipients took either Avandia or a related drug, Actos. Dr. David Graham of the FDA, the study’s lead author, says the results were alarming.

“If you treated 60 people for a year with Avandia, you would cause one extra case of heart attack, stroke, heart failure or death,” Graham says, “compared to if you had treated 60 patients with Actos.”

That’s a substantial difference. Graham says it means nearly 50,000 elderly Americans have died or had heart attacks, strokes or heart failure due to Avandia since the drug came on the market in 1999. Add in those under the age of 65, the number is probably 100,000, Graham says…

..Avandia still brings in more than $1 billion a year for Glaxo in worldwide sales, about a half in the United States…

..Graham, the FDA’s most vocal inside critic, says the way the agency has handled Avandia shows it has failed to learn the lessons of the painkiller Vioxx, whose maker pulled it from the market in 2004 after studies indicated it raised the risk of heart attacks.

What Vioxx and Avandia represent, Graham says, “is a failure of FDA decision-making -– a failure to place patient safety first, ahead of corporate profits.”…

much more at Diabetes Drug Poses Safety Test for FDA

here is a link to the New York Times Story

for those of you who like the technical details here is a link to the Graham Avandia study in JAMA

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