FDA To Go For More Test For Diabetes Drug To Avoid Heart Problems
At the two day meeting on the standard of diabetes drug, the FDA officials have decided that the testing standard on the type 2 diabetes drug should more thorough to avoid 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.
Cardiovascular risk assessment should be done before the agency gives approval to any diabetes drug. The panel of the experts said that long-term trials could follow once the drug was on the market. 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.
It can be added that the FDA meeting was organized in response to the harsh criticism it has received for its handling of the type 2 diabetes drug some two year back. The agency has received criticism mainly over the drug named 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.
The concern about the effects of the drug Avandia was raised by Dr. Steven Nissen, chairman of the Cleveland Clinic’s department of cardiovascular medicine.
The Canadian label says Avandia is not to be used as the sole medication for type 2 diabetes except for patients who can’t take metformin, another drug that also lowers blood sugar. The label also states that Avandia is not to be used by any patient with heart failure.
It can be recalled that the controversy over Avandia started in May 2007 with the publication of a study in the New England Journal of Medicine. The study was done by Nissen and colleague Kathy Wolski. The team of the experts found a 43 percent increased risk of heart attack among patients taking the drug. On Tuesday, Nissen told the FDA advisers that the agency should make companies demonstrate that their type 2 drugs do not increase risks of cardiovascular disease before being approved.
Source: Forbes.com
Filed under Blood Sugar Testing, Diabetes, Diabetes Drug, NIDDM
