Advisers urge more tests of diabetes drugs
SILVER SPRING, Maryland (Reuters) - U.S. regulators should require more testing of the potential heart risks of new diabetes medicines, an advisory panel said on Wednesday.
By a 14-2 vote, the advisers to the Food and Drug Administration recommended companies conduct a long-term study or provide equivalent evidence to rule out an unacceptable risk of heart problems for proposed new diabetes medicines.
Some data could be collected before approval with additional results provided after the drug reaches the market, several panel members said.
If the FDA adopts the advice, drugmakers could be forced to run longer and more expensive studies in a larger group of patients. The agency usually follows the advice of its advisory panels.
Concern about heart risks arose last year when a study by Cleveland Clinic researchers found GlaxoSmithKline Plc's diabetes pill Avandia increased the chances of a heart attack.
Diabetes medicines are among the biggest selling drugs. U.S. sales of the leading diabetes drugs exceeded $6 billion in 2007, according to healthcare information company IMS Health.
Several drugmakers, including Glaxo, Bristol-Myers Squibb Co, AstraZeneca Plc, Eli Lilly and Co and Amylin Pharmaceutical Co, are working to bring new diabetes drugs to the market.
(Reporting by Lisa Richwine; editing by Tim Dobbyn)
