The widely used diabetes drug Avandia should remain on the market, U.S. government health advisers recommended Monday. They say evidence of an increased risk of heart attack from taking GlaxoSmithKline's Canadian-manufactured drug doesn't merit removal.
"Although we didn't vote to take it off the market, I think we certainly sent a clear message that there are going to be changes in the way that this is promoted," said Dr. Clifford Rosen of St. Joseph Hospital in Maine.
The non-binding recommendation to the Food and Drug Administration came on a majority vote by the panel.
"We're being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision," said Rebecca Killion, a Bowie, Md., diabetic and the panel's patient representative.
Earlier, U.S. Food and Drug Administration scientist David Graham told a U.S. government panel Monday the drug should be pulled off shelves.
He said the drug's heart risks -- combined with its lack of unique short-term benefits in helping diabetics control blood sugar -- meant continued sales were not justified.
Graham made his remarks to an advisory panel convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings, or removed altogether from sale.
Canadians filled more than one million prescriptions of Avandia, seen as one of the main weapons in the fight against diabetes, last year to control type 2 diabetes.
But Avandia increases the risk of cardiovascular problems such as heart attacks, Graham said. The drug is particularly dangerous to patients who take insulin, Graham's report will say -- a risk not found with rival drug Actos, made by Takeda Pharmaceutical Co. Ltd.
"The compass needles for (Avandia) ... all point to an increase in coronary heart disease risk," Graham told the panel of experts from outside his agency.
Graham, a scientist in the FDA office that monitors the safety of medicines after approval, has been outspoken about the risks of Avandia. He has publicly criticized top FDA officials for failing to respond to warning signs about this drug and other.
Other FDA officials testified that they remain unsure if the drug truly contributes to heart attacks, pointing to other research that conflicts with that finding.
"It's important that the committee understand there is a fundamental disagreement within the (Center for Drug Evaluation and Research) on the scientific conclusions that should be drawn," said Dr. Robert Meyer, director of the FDA office that reviews diabetes drugs.
GlaxoSmithKline, meanwhile, says that Avandia, which has been on the market since 1999 to help Type 2 diabetics control blood sugar, is no more dangerous than other diabetes pills. Representatives of the drug company will make their case later today before the panel of outside experts.
"There is no overall evidence that (Avandia) is different from other oral anti-diabetic agents" with regard to heart attack risk, Murray Stewart, Glaxo vice president for clinical development, told the panel.
The company saw global sales of more than US $3 billion last year from the drug.
Avandia has been the subject of hot debate since a study was published in the New England Journal of Medicine in May that generated new concerns about the drug's safety. The analysis of 42 studies revealed a 43 per cent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.
Since patients with Type 2 diabetes are already at higher risk for heart attacks, the news that the drug might raise this risk by 43 per cent was especially disturbing.
The FDA issued a "safety alert" about the drug after the May NEJM study.
FDA officials asked the advisory panel to decide if the drug should come off the market or remain on sale but with stronger warnings or limits.
FDA has updated the product's labeling on several occasions. Currently, Avandia's label warns about possible heart failure and other heart problems when taken with insulin. The drug also raises LDL, or bad cholesterol, and can cause fluid retention and weight gain.
Panel recommendations are expected on Monday afternoon. The FDA isn't required to follow the advice of its advisory committees but usually does.
Health Canada, meanwhile, says Avandia may be used alone or in combination with other medications. The agency says patients prescribed Avandia should not stop taking it without first consulting their health care provider.
Avandia's generic name is rosiglitazone, while Actos' is pioglitazone. Both drugs are part of drug class called thiazolidinediones and are designed to make the body more sensitive to insulin, a hormone the body needs to convert sugar into energy.
Diabetes facts:
- Diabetes is one of the fastest growing diseases in Canada and around the world.
- One in 10 Canadian adults has type two diabetes.
- About 60,000 new cases are diagnosed every year.
- Diabetes is the seventh leading cause of death in Canada.
- It costs the Canadian health care system about $9-billion a year.
With reports from CTV's Scott Laurie and The Associated Press
