Piling On to Avandia

The FDA now thinks that Avandia should be pulled from the market based on increased risks and no signifcant benefits not offered by other products...

At risk of piling on, how come this drug was on the market in the first place...

Note to manufacturer's: if you're the first, I guess the FDA will accept the risks because no other treatment is available...the bar seems to be raised, even if retroactively in this particular case, for those who follow on...

Expert: Diabetes drug should be pulled

WASHINGTON - The widely used diabetes drug Avandia should be pulled from the market because of heart risks, a federal scientist said Monday.

Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.

The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

Glaxo officials, meanwhile, disputed that claim, citing their own analyses of studies of Avandia, also called rosiglitazone.

"The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents," said Dr. Ronald Krall, the company's senior vice president and chief medical officer.

The FDA isn't required to follow the advice of its advisory committees but usually does.

The FDA moved up the date of Monday's meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia's safety. The pooled analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

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