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Diabetes drug faces bans as heart attack risk reviewed

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Postby rath » Wed Jul 14, 2010 11:12 pm

LONDON: The popular diabetes drug Avandia is facing withdrawal from sale in Europe and the US after research linked it to a higher risk of heart problems, strokes and deaths in older adults.

The European Medicines Agency said that its review would be conducted by its Committee for Medicinal Products for Human Use when it meets from July 19 to July 22. The committee could change or revoke the drug's marketing authorisation for the drug in Europe.

The US Food and Drug Administration will hold hearings on Tuesday and Wednesday.


GlaxoSmithKline, the drug's maker, said it was confident the drug ''is an important treatment option for appropriate type 2 diabetes patients''.

Last year worldwide sales of Avandia, which has been on the market since 1999, were about $US800 million ($900 million) worldwide, making it one of the top-selling diabetes treatments and overall drugs. It is used by 15,000 Australians and 52,000 people worldwide.

A document made public by the Food and Drug Administration cited Thomas Marciniak, one of its experts on cardiovascular treatments, who said trials of the drug, whose generic name is rosiglitazone, were ''inadequately designed'' and the record ''suggests the rosiglitazone increases the risk'' of heart attacks.

''Half of the errors were substantial,'' he said.

''If consulted in advance I would have rejected this study design as inappropriate and biased.''

Allegations from a former Food and Drug Administration official have arisen that Glaxo withheld from regulators a study showing Avandia might cause heart attacks.

A former drug safety unit manager, Rosemary Johann-Liang, told lawyers suing Glaxo that the study found in 2001 that Avandia posed a greater heart attack risk than rival medicines. Glaxo also did not hand in an email from researchers who concluded Avandia ''strengthens the signals'' of heart ailments, Dr Johann-Liang said in a pre-trial deposition last month.

She left the Food and Drug Administration in 2007 after recommending that Glaxo add more information about health risks to Avandia's label.

While Glaxo officials said no studies had proven Avandia was dangerous, some safety advocates wanted the medicine to be withdrawn from sale immediately.

Glaxo spokeswoman Mary Anne Rhyne declined to comment immediately on the deposition.

Avandia was once the world's best-selling diabetes pill, generating annual revenue of $US3 billion by 2006, including sales of a combination pill called Avandamet. Sales plunged after a report in The New England Journal of Medicine in May 2007 linked the drug to a 43 per cent increase in the risk of heart attacks. That prompted US and European regulators to order Glaxo to strengthen its warnings.

Glaxo, Britain's biggest pharmaceutical company, faces about 13,000 lawsuits over Avandia
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Postby rath » Wed Jul 14, 2010 11:16 pm

GSK wins crucial FDA vote on diabetes drug Avandia

GlaxoSmithKline's diabetes drug, Avandia, should be allowed to stay on the market but with additional warnings, advisers to the US's medicines watchdog voted yesterday.

Having spent two days hearing conflicting evidence over whether or not Avandia can pose a risk to the heart, 20 members of a 33-strong advisory committee to the Food and Drug Administration (FDA) voted to keep Avandia on the market while 12 voted to pull it and one member abstained.

However, 17 members of the panel advised that the drug should be sold with new restrictions or warnings, while three panel members said no changes were needed to the drug's prescribing information.


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The FDA is not obliged to follow the recommendations of advisory panels, but often does.

Earlier in the day, the panel had voted that there was an increased concern about heart attacks with Avandia versus other diabetes drugs, but they voted against finding a greater risk of death with Avandia.

Controversy has dogged Avandia since 2007 when a study first claimed it could be linked to cardiac risks. But, GSK has vigorously defended the drug, saying that since then, six clinical trials have shown it to be safe.

Responding to the vote, GSK's chief medical officer, Dr Ellen Strahlman, said: "We would like to acknowledge the efforts made by the FDA to apply scientific rigour to the debate and understanding of the benefit-risk profile of Avandia,"

She added: "Following [the] recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease."

Mike Ward, an analyst at Ambrian, said last night: "I think [the vote] is stronger in favour than many people would have thought."
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