 | | | | Related Healthscout Videos | |
|
WEDNESDAY, July 2 (HealthDay News) -- Drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems, U.S. Food and Drug Administration advisers said Wednesday.
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.
Text Continues Below
Most of the panel members also said that trials assessing cardiovascular risk should be done before a drug is approved; these could be a part of a phase III trial to rule out any significant heart risk. Long-term trials could follow once the drug was on the market, the advisers 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.
Although the FDA is not required to follow its advisory panels' recommendations, it usually does.
The panel's vote comes less than a year after the FDA was harshly criticized for its handling of the type 2 diabetes drug Avandia (rosiglitazone), made by GlaxoSmithKline. The drug was approved in 1999, but the FDA added a "black box" warning about an increased risk of heart attack last November. And the agency decided to keep Avandia on the market because it concluded that the risk of heart attack wasn't any higher than that associated with similar medications.
Dr. Steven Nissen, chairman of the Cleveland Clinic's department of cardiovascular medicine, first raised concerns about Avandia and heart attack risk in a study published last year. He said in November that he welcomed "the addition of a black box warning for the risk of heart attack from Avandia," but would have preferred a warning "written with greater clarity," like the one used by Health Canada, the FDA's counterpart in Canada.
Page: 1 | 2 | Next >>
|
.gif)
