The Associated Press

The European agency that evaluates medicine said Friday it will review the safety of the diabetes drug following research suggesting it is linked to a higher risk of heart problems, strokes and deaths in older adults.

Friday’s announcement came a day after the U.S. Food and Drug Administration published documents setting the stage for its own Avandia hearings next week. (For meeting information and background, )

The review by federal health scientists reinforces potential ties between Avandia and heart attack and death, opening the door for government action, including a possible withdrawal of the once blockbuster drug.

The FDA posted an exhaustive 700-page review of the drug online ahead of a meeting next week to review the safety of Avandia, which is used by hundreds of thousands of diabetics in the U.S.

A panel of outside expert physicians will vote on a range of recommendations including:

  • adding additional warning labels to the drug
  • allowing only certain doctors to prescribe the drug
  • pulling the drug from the market

The FDA is not required to follow the advice of its outside panels, though it usually does.

Part of the reason the FDA is seeking outside advice is because of disagreements among its own scientists.

"There’s not complete unanimity within the FDA about interpretation of these data and that’s one of the reasons we’re going to the advisory committee," said Dr. Janet Woodcock, head of the FDA’s drug center.

Avandia was Glaxo’s third best-selling drug in 2006 with U.S. revenue of $2.2 billion, according to health care statistics firm IMS Health. But safety concerns swirling around the drug have pummeled sales since 2007, with sales falling 75 percent to $520 million last year.

In 2007 an analysis of dozens of studies first linked the drug to heart attacks. The FDA responded by adding a warning label to the drug later that year.

But new data on Avandia’s risks and pressure from Capitol Hill have prompted the agency to re-examine the drug’s safety.

Despite the drop off, Avandia is still used by hundreds of thousands of Americans with type 2 diabetes to control blood sugar levels. The drug works by increasing the body’s sensitivity to insulin, a key protein needed for digestion that diabetics lack.

That sort of treatment has long been presumed to lessen the heart risks already associated with the disease.

But critics of Avandia, including a high-profile FDA scientist, argue there are safer alternatives to GlaxoSmithKline’s drug.

Last month a leading medical journal published an analysis suggesting Avandia is more likely to cause strokes and heart-related death than a rival drug, Actos.

The paper’s author Dr. David Graham, the FDA scientist who wants the pill banned, estimated as many as 100,000 heart-related adverse events may have been caused by Avandia during its time on the market.

Graham and several colleagues analyzed medical records of more than 225,000 elderly Medicare patients taking Actos or Avandia.

Actos is made by Japan-based Takeda Pharmaceuticals and has gobbled up 70 percent of the market for diabetes drugs in Avandia’s class. Avandia currently holds just 11 percent of the U.S. market.

Prescriptions for the drug have plummeted since 2007, when a medical journal article first linked the drug to heart attacks. The FDA responded by adding a warning label to the drug.

But new data on Avandia’s risks and pressure from Capitol Hill have prompted the agency to re-examine the drug’s safety.

The European Medicines Agency said the review will be conducted by its Committee for Medicinal Products for Human Use when it meets from July 19 to July 22. Depending on the outcome, marketing authorization for the drug in Europe could be revoked or changed.

The FDA will hold hearings on Avandia, also known as rosiglitazone and made by GlaxoSmithKline PLC (NYSE: GSK), on Tuesday and Wednesday.

In a statement, GSK continued to defend the drug.

"GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate Type 2 diabetes patients," said Dr. Tony Hoos, European medical director for GlaxoSmithKline.

"It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients," he said. He said patients should not stop taking the drug without consulting their doctors.

GSK maintains its U.S. headquarters in Research Triangle Park, N.C. and its global headquarters in London.

The European Medicines Agency said the drug was authorized for use but with warnings about prescribing for patients with heart failure or a history of heart failure, or to patients with heart problems.

Two years ago, the European committee, known as CHMP, concluded that the drug "retained a small, if diminishing, place in diabetes Type 2 therapy."

A in the United States last month linked Avandia to a higher risk of heart problems, strokes and deaths in older adults, and called it more dangerous than a rival drug, Actos.

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