US FDA seeks more study of diabetes drug heart risk

By Lisa Richwine

WASHINGTON (Reuters) - Drug companies need to more thoroughly study potential heart-related risks of new diabetes medicines before they reach the market, U.S. health officials said on Wednesday.

The decision will mean longer, larger and more expensive studies for many drugmakers seeking to sell new therapies in a $6 billion U.S. market that was hit by safety concerns with GlaxoSmithKline Plc's (GSK.L) diabetes pill, Avandia.

Companies must "ensure that a new therapy does not increase cardiovascular risk to an unacceptable extent," the Food and Drug Administration said in new guidelines.

Glaxo, Bristol-Myers Squibb Co (BMY.N), AstraZeneca Plc (AZN.L), Eli Lilly and Co (LLY.N), Amylin Pharmaceutical Inc (AMLN.O) and Novo Nordisk (NOVOb.CO) are among the companies trying to bring new diabetes drugs to the market.

The new standards apply immediately to all diabetes drugs in development, and drugmakers have been notified, the FDA said.

Until now, companies generally needed to show only that their diabetes medicines lowered blood sugar.

The FDA, however, has grown concerned about heart attacks and other cardiovascular risks from medicines taken long-term to treat chronic conditions.

Nearly 24 million Americans have diabetes, the U.S. government estimates. Most cases are type 2 diabetes, which is linked with obesity, poor diet and lack of exercise.