Avandia faces ban in Europe, severe limits in U.S.

By Reuters
Posted Sep. 23, 2010 at 12:51 p.m.

European regulators said Thursday GlaxoSmithKline’s diabetes drug Avandia should be taken off the market but U.S. officials allowed it to stay, with major restrictions due to concerns about heart risks.

The differing rulings were an attempt to end a row over drug safety that has dogged the reputation of the medicine and its maker in recent years.

In separate but coordinated statements, the Food and Drug Administration in Washington and the European Medicines Agency in London said they agreed on the risks associated with the drug but had reached different conclusions.

Avandia was once Glaxo’s second-biggest seller but sales have tumbled in recent years and Glaxo said it expected minimal sales in future.

“The decisions are not surprising and are a significant negative both for Glaxo and Avandia. It’s no longer a very important product for Glaxo, and will become even less so,” said Viren Mehta, principal at Mehta Partners.

But Mehta and other analysts said Glaxo would have some protection from further potential U.S. product liability lawsuits now that Avandia will remain on the market in the U.S., however limited its sales potential might be.

European officials said the drug’s suspension was expected to be formally endorsed by the European Commission within two weeks.

Both Avandia, known generically as rosiglitazone, and its main rival Actos, or pioglitazone, made by Takeda Pharmaceutical, are known to raise the risk of heart failure, where the heart fails to pump blood efficiently.

But Avandia has also been linked to an increased risk of heart attacks, after publication of a study in 2007 by Dr. Steve Nissen of the Cleveland Clinic, whose findings prompted the latest safety reviews.

Nissen’s results, however, have been contested by Glaxo and some other researchers. Dr. Janet Woodock, director of the FDA’s Center for Drug Evaluation and Research, said the true risk of heart attack associated with Avandia was unclear.

“As a matter of prudence, we are restricting access. We are not withdrawing the drug at this time because there is considerable uncertainty about this signal and whether or not it’s valid,” she told reporters in a conference call.

Requiring patients and doctors to meet certain criteria in order to get the drug “means people will think twice” before using Avandia, she added.

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