Avandia too risky says expert

Jul 30 2007

One of the members of the advisory panel set up to discuss the future of the diabetes pill Avandia says it should be removed from the market because it is too risky and offers no advantage over other alternatives.

Panel member Dr. David Graham says his analysis showed the drug Avandia increased heart attacks and other cardiac problems while rival drugs did not.

The advisory panel to the Food and Drug Administration (FDA) is considering whether the widely used drug should be withdrawn or remain on the market with new warnings about possible heart risks.

The manufacturer GlaxoSmtihKline argues that Avandia is no more dangerous to the heart than other diabetes pills.

Avandia is the company's second-best-selling drug.

Around the world millions of diabetics now take Avandia but the drug's safety was questioned following research in May by the Cleveland Clinic which linked the drug to a 43 percent higher chance of having a heart attack.

Dr. Gerald Dal Pan, head of the FDA office that reviews the safety of drugs after approval, agrees that Avandia's benefits did not outweigh the risks.

However other FDA officials remain unsure if the drug does contributes to heart attacks, pointing to other research that conflicts with that finding.

Dr. Robert Meyer, director of the FDA office that reviews diabetes drugs says it is 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.

As a rule the FDA usually follows the panel's advice.

It is estimated that as many as 21 million Americans have type 2 diabetes, a disease in which the body does not adequately control blood sugar. Patients are at risk for heart disease, kidney failure, limb amputations and other serious complications.

Glaxo said Avandia should remain an option because many patients need multiple drugs to keep blood sugar under control, and a portion of them cannot take some of the other therapies.

Dr. Graham, however disagrees and says his analysis showed the drug did increase heart attacks and other cardiac problems while rival drug Actos, made by Takeda did not.

Avandia is known generically as rosiglitazone, while Actos is known as pioglitazone; both drugs are so-called thiazolidinediones that were designed to make the body more sensitive to insulin, a hormone the body needs to convert sugar into energy.

The controversy is also affecting the debate over how effective the FDA is at making sure medicines are safe and Congress is now debating changes in the way the agency operates.

Glaxo still asserts that its studies show Avandia is safe and effective but FDA panel member John Teerlink, who is a heart failure expert at the University of California says relying on those committees who oversee clinical trials is "irresponsible".

Also a study from a rival drug company contradicts one analysis Glaxo is using to defend Avandia which showed no increase in risk for Avandia, compared with other diabetes drugs, but Actos, a similar drug, was missing from this study.

A new analysis that compares Actos and Avandia found that patients who were given Actos were at lower risk of having a heart attack than those who received Avandia.