Keep Avandia on market, say FDA advisers

FDA panelists suggest that Glaxo's diabetes drug Avandia remain on the market, while acknowledging studies showing links to increased heart attack risks.

By Aaron Smith, staff writer

NEW YORK ( -- Food and Drug Administration panelists voted Monday that GlaxoSmithKline's diabetes drug Avandia should remain on the market, despite an analysis showing links to increased risk of heart attack.

Advisers voted 22-1 in favor of keeping Avandia on the U.S. market, while acknowledging the risks of the drug. This is not a binding vote, but is taken as a suggestion to FDA regulators.

Nonetheless, the panel - meeting in Gaithersburg, Md. - also voted 20-3 that data shows that Avandia increases the risk of cardiac ischemia, a condition that blocks blood flow and oxygen to certain parts of the body, in patients with the most common type of diabetes.

Earlier Monday, an adviser suggested that Avandia be taken off the market because it increases cardiovascular risk, but GlaxoSmithKline (down $0.20 to $49.43, Charts), the maker of the drug, disputed the comments.

The FDA panel was convened to discuss the potential risks of Avandia, one of Glaxo's top sellers with $3 billion in 2006 sales.

"Rosiglitazone should be removed from the market," said FDA adviser Dr. David Graham at the meeting, using the scientific name from Avandia.

Graham said studies suggested that Avandia increased cardiovascular risk, a relatively broad medical condition that is the leading cause of death in diabetics - the patients who are prescribed to take the drug.

"Any drug that increases the risk of coronary heart disease is diabetics is unacceptable," said Graham.

Graham also said that Avandia's risk profile made it "inferior" to the competing drug Actos, which he said decreases cardiovascular risk. Actos is made by Takeda Pharmaceuticals.

Glaxo's blockbuster drug has come under fire in recent months after the Cleveland Clinic's lead cardiologist Dr. Steven Nissen published a report in the New England Journal of Medicine linking the drug to increased risk of heart attacks.

Dr. Nissen's report has been hotly disputed, and British-based Glaxo has criticized the doctor's report for being a "meta-analysis" of 42 previous studies - including those conducted by Glaxo - rather than a clinical trial in its own right.

Glaxo reiterated that Graham is merely one adviser on a 23-member panel.

"We disagree that Avandia should be taken off the market," said Glaxo spokeswoman Nancy Pekarek, in an e-mail to "Dr. Graham is just one person on the panel - there are many other presentations to be heard today, including [Glaxo's,] which reinforce our position that Avandia is safe when used appropriately."

The FDA has grown increasingly cautious about drug safety, after Merck & Co. (up $0.00 to $50.12, Charts, Fortune 500) pulled its FDA-approved anti-arthritis painkiller Vioxx off the market in 2004 because of links to heart attacks and strokes. Dr. Nissen was also an outspoken critic of Vioxx, and since the withdrawal of the drug, about 27,000 lawsuits have been filed against Merck.

Avandia is a member of the same drug class as Takeda's Actos, though Actos has not been accused of increasing heart attack risks. But both drugs carry FDA warning labels for increasing the risk of heart failure.

A heart attack occurs when low blood flow causes oxygen starvation in the heart, resulting in death or permanent heart damage, according to the National Institutes of Health. Heart failure - in which the heart has difficulty pumping blood throughout the body, resulting in shortness of breath - is a common symptom in heart attack survivors.

The bad news surrounding Avandia has taken a bite out of drug sales for Glaxo. Barbara Ryan, analyst for Deutsche Bank North America, said in a published note that prescription volumes for Actos were up 19 percent for the week ended July 20, compared to the week before the May 18 publication of Nissen's article.

Likewise, prescription volumes for another competing diabetes drug, Januvia from Merck, were up 25 percent over the same time period, while volumes for Avandia were down 50 percent, Ryan said. Top of page