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FDA Restricts Glaxo Diabetes Drug Avandia

The FDA restricts access to GlaxoSmithKline's diabetes drug Avandia as questions arise about the drug's safety.

(Avandia, GlaxoSmithKline story updated for European market banning of diabetes drug)



) -- The U.S. Food and Drug Administration announced on Thursday that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone), manufactured by


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, to patients with Type 2 diabetes who cannot control their diabetes on other medications.

The FDA mandated the Avandia restrictions in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

GlaxoSmithKline shares were down by less than 1% at midday, on heavy volume -- about three times its average daily trade volume.

It's not the first problem for Avandia. The drug came on the market in 1999 and achieved annual revenue of $3 billion by 2006, but last year sales of Avandia fell to $1.2 billion, two years after the

New England Journal of Medicine

published a study that linked Avandia to a 43% increased risk of heart attack. The FDA had previously asked GlaxoSmithKline to remove the drug from the market, and some expected that the FDA might pull the drug at this point, as opposed to issuing a set of restrictions on its use.

"The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks," said FDA Commissioner Margaret A. Hamburg, M.D. in a statement. "We are seeking to strike the right balance to support clinical care."

European regulators, in fact, made the harsher call on Avandia that some in the U.S. had been expecting, announcing almost simultaneously with the FDA that Avandia was being pulled from the European market. "Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone," the European Medicines Agency said in an e-mailed statement.

Trading in GlaxoSmithKline shares had bounced back from heavy losses in the morning at midday, but after the EU news broke, the shares slumped again and heavy trading continued.

Rosiglitazone also is available in combination with other diabetes medications under the brand name Avandamet and Avandaryl. Avandia is in a class of drugs known as thiazolidinediones, or TZDs, intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.

GlaxoSmithKline is required as a result of the FDA action to develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, meaning Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class, and made by Japan's Takeda Pharmaceuticals.

"Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research in a statement.

The FDA also ordered GSK to put together a group of independent scientists to review key aspects of the company's clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs.

"During the course of the FDA's review of the RECORD study, important questions arose about potential bias in the identification of cardiovascular events," the FDA said in its statement.

In addition, GSK's clinical trial known as TIDE, comparing Avandia to Actos and to standard diabetes drugs, has been halted.

--Written by Eric Rosenbaum in New York.

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