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Recall Avandia? "Keep an open mind," says one FDA commissioner

A Food and Drug Administration commissioner said today that regulators considering a recall of GlaxoSmithKline's diabetes pill Avandia should "keep an open mind," Bloomberg News reports.

Margaret Hamburg made her comments during the first day of a two-day FDA advisory panel meeting on Avandia being held in suburban Washington.

"Follow the science, wherever it leads, and the rest will fall into place," Hamburg said.

Bloomberg also reported today that GSK has agreed to pay $450 million to settle a majority of the lawsuits, about 10,000, alleging Avandia can cause heart attacks and strokes.

At the conclusion of the two-day hearing, the panel is expected to recommend to the FDA whether the drug should be pulled or whether new warnings or restrictions are warranted because of safety concerns.

Patients avoiding Avandia drug trials

GlaxoSmithKline is having trouble recruiting patients for a large clinical trial of its controversial diabetes drug Avandia, the Wall Street Journal reports this morning.

The drug has been linked to an increased risk of heart attack, but GSK officials have said it's a safe and effective product. Federal regulators are considering whether to halt the so-called TIDE clinical trial early because of Avandia's health risks.

Two sites, including Wake Forest University Baptist Medical Center in Winston-Salem, have pulled out of the safety study, GSK reports. The British company, which has its North American headquarters in Research Triangle Park, didn't name the second site.

GlaxoSmithKline reportedly settles Avandia suits

GlaxoSmithKline has reportedly agreed to pay about $60 million to settle 700 lawsuits alleging that its Avandia diabetes drug causes heart attacks and other health problems.

Bloomberg News reported the settlements today, citing unnamed sources.

Officials with the British drugmaker, which has its North American headquarters in Research Triangle Park, declined to comment on possible settlements.

“GlaxoSmithKline stands by Avandia and is fully prepared to defend any litigation,” spokeswoman Bernadette King said in an e-mailed statement.

GSK faces about 4,000 lawsuits so far over the drug, and is preparing for the first trial, in state court in Philadelphia, in July.

FDA reviewing study of GSK's Avandia

Federal regulators are reviewing whether to stop a safety study of GlaxoSmithKline's controversial diabetes drug Avandia, which some critics say should be pulled off the market.

Studies have tied the medicine to an increased risk of heart attacks, but GSK says that the drug is safe and effective.

Now the Food and Drug Administration is reassessing an ongoing study comparing Avandia with a rival medicine, and whether it's ethical to continue the research amid mounting health concerns, FDA commissioner Margaret Hamburg wrote in a letter dated March 30.

The Wall Street Journal first reported on Hamburg's letter, saying that a decision to halt the trial also may determine whether the FDA asks GSK to pull the drug off the market.

Sales of GSK's Avandia suspended in Saudi Arabia

Avandia, the GlaxoSmithKline drug that is being scrutinized by U.S. regulators for possible links to heart attacks, is now under attack in Saudi Arabia.

The Saudi Food and Drug Authority has suspended sales of Avandia for six months, Bloomberg News is reporting. The agency is giving the drug maker that much time to show why the drug shouldn't be banned in the country.

Avandia's safety has been questioned in recent years as it has been linked to heart attacks and other cardiovascular problems. Some U.S. lawmakers and physicians have asked the U.S. Food and Drug Administration to review the drug's safety and pull it from the market.

GSK, which employs about 5,000 people in the Triangle, has replied to critics by saying that clinical data proves Avandia is safe and effective.

The drug's sales have been declining since 2007, when its link to heart problems surfaced.  Still, GSK realized $1.2 billion in worldwide sales of Avandia last year.

The FDA announced earlier this year that its advisory committee would meet in July to consider Avandia's safety.

GSK defends Avandia as criticism increases

A scathing Senate committee report on the safety of the diabetes drug Avandia contains errors, misleading conclusions and incomplete information, GlaxoSmithKline wrote in its official response, which the company posted online this morning.

"GSK stands behind the safety of Avandia," the drug maker wrote in the response. "The company rejects any allegations of concealing safety information or acting inappropriately on behalf of patients."

The Senate report is just the latest salvo from critics who say the drug, which was approved in 1999, can cause heart attacks or other health problems. Some lawmakers and physicians are calling for the Food and Drug Administration to review its safety and pull it off the market.

GSK said it welcomes a "fair examination of the company's record" and the clinical data that proves Avandia is safe and effective.

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