Glaxo diabetes drug should stay on market: U.S. panel

By Lisa Richwine

GAITHERSBURG, Maryland (Reuters) - GlaxoSmithKline Plc's diabetes pill Avandia should stay on the market even though data suggest it may raise the risk of a heart attack for some patients, U.S. advisers said on Monday.

Most of the advisory panel said the Food and Drug Administration should ask for strong new warnings on the widely used drug, but evidence was too thin to justify halting sales.

Data "does suggest there is an increased risk," said Dr. Clifford Rosen, the panel's chairman.

After hearing various analyses of a mass of data, the panel voted 20-3 that Avandia may increase the chances of having a heart attack for some patients.

Members voted 22-1 that Avandia should stay on the market.

Glaxo shares rose 5.2 percent in extended U.S. trading to $52 from their close of $49.43 on the New York Stock Exchange.

Millions of diabetics around the world take Avandia, Glaxo's second-best-selling drug. Its safety came into question in May, when a Cleveland Clinic analysis linked Avandia to a 43 percent higher chance of having a heart attack.

Glaxo and senior FDA officials said other evidence conflicted with that finding.

The advisory panel felt certain diabetics face greater heart risks than others, Rosen said. They include patients with heart failure or significant cardiovascular disease, or diabetics taking nitrates or insulin.

Some urged a "black box" warning on Avandia, the strongest type of warning for prescription drugs.

The FDA usually adopts the recommendations of advisory panels, which are groups of experts from outside the agency.

Inside the FDA, officials have been split about how to deal with Avandia. Outspoken FDA scientist David Graham said he saw a higher heart attack risk and no advantage over alternatives.

Takeda Pharmaceutical Co. Ltd.'s rival drug, Actos, did not appear to carry the same risk, Graham said.

His boss, Dr. Gerald Dal Pan, agreed, and both said they felt the drug should come off the market. Dal Pan runs the FDA office that monitors side effects after a drug's approval.

Other officials in the division that approves drugs for sale told the panel they were unsure how risky Avandia was and were seeking the panel's advice.