Archive for the 'Medicines' Category

FDA panel calls for more testing of diabetes drugs

Thursday, July 17th, 2008

The U.S Food and Drug Administration adviser on Wednesday said that Drugs designed to control type 2 diabetes should be subjected to more through safety reviews to ensure they don’t raise the risk of heart problems.The panel of outside experts voted 14-to-2, at the end of a two-day meeting, to recommend that all makers of these drugs conduct long-term cardiovascular trials, even if the drugs show no signs of heart problems in initial trials.

Majority of the panel members also recommended that trials assessing cardiovascular risk should be carry out before a drug is approved for the market; these could be a part of a phase III trial to rule out any significant heart risk. Long-term trials could follow once the drugs was on the market, the adviser said.

Currently, the FDA only requires that drugs for type 2 diabetes lower blood sugar, which is thought to protect diabetics from the debilitating side effects of the disease. (more…)