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FDA To Ask If Avandia Should Stay In The Market

Posted: Friday, August 03, 2007

The FDA will ask outside advisers if GlaxoSmithKline Plc's diabetes drug Avandia should stay on the market or be subject to new warnings or limits. 

The agency has "considerable concern" about data that show a signal of possible heart attack risks with Avandia, a summary from FDA staff said. Various data present "somewhat inconsistent findings," it added.

The FDA released the summary among more than 400 pages of documents prepared for Monday's advisory panel review of the drug's heart risks.

Avandia's safety came into question in May when a Cleveland Clinic analysis linked the drug to a 43 percent higher chance of having a heart attack.

That study, by cardiologist Steven Nissen, will not be a focus of the panel meeting, FDA staff said. Agency reviewers believe their own analysis used more robust data, they said. Nissen is listed as a non-voting consultant for the meeting.

The panel will be asked if Avandia increases heart attack risk, and if so, whether the dangers are greater than with other diabetes drugs. They also will be asked if Avandia should stay on the market, the FDA documents said.

If the advisers decide Avandia should still be sold, the FDA will ask about other steps, such as adding a strong "black box" warning or limiting use to certain patients.

The FDA usually follows panel recommendations.

Agency staff said "various data sets present an array of somewhat inconsistent findings that complicate the interpretation of the available data."

In one analysis, FDA statisticians found a "consistent increase" in risks of heart attacks and related problems in studies that added Avandia to insulin.

"Use with insulin should be carefully re-assessed," the analysis said.

Combined results from 42 studies showed an increased heart attack risk overall, FDA reviewers said, but added that the studies were short with no rigorous follow-up of patients. Longer studies by Glaxo have found no statistical difference between Avandia and some other medicines when researchers looked at combined rates of cardiovascular-related deaths, heart attacks and strokes, FDA staff said.

Glaxo said a new company-funded study of health insurance records of more than 400,000 diabetics found Avandia was not linked with a higher heart attack risk compared with other oral diabetes drugs. The company said the finding supported previous data.

"We feel the cardiovascular profile is very reassuring for Avandia," Dr. Anne Phillips, GlaxoSmithKline vice president of clinical development, said in an interview.

Avandia, known generically as rosiglitazone, is also a component of Glaxo's Avandamet and Avandaryl diabetes pills.

Summaries from FDA staff and Glaxo were posted on the agency Web site at

Source: Diabetes In Control

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