Test Diabetes Drugs for Possible Heart Risks
Submitted by Carina Rose on Thu, 07/03/2008 - 10:47
The U.S. Food and Drug Administration panel has recommended that diabetes drugs should undergo more stringent tests to ensure patients’ safety. Currently the drugs given for type 2 diabetes are required by the FDA to lower the blood sugar only but experts feel that the drugs should undergo longer screening to ensure that they don’t increase chances of heart problems. The advisors voted 14-2 in favour of more stringent testing.
According to a report in the Wall Street Journal, Dr. Steven Nissen, chairman of the Cleveland Clinic's department of cardiovascular medicine, told the FDA advisers that the agency should make companies demonstrate that their type 2 medicine does not increase risks of cardiovascular disease before being approved.
"Merely lowering blood-glucose levels in diabetes is too simplistic," Nissen told the panel. "We must reduce the complications of diabetes, including cardiovascular disease," he added.
A majority of the panel felt that drug companies should begin safety testing before they submit the drugs to the FDA, and should finish the studies once the drugs are on the market. The downside to this being that the testing could likely cost tens of millions of dollars, and take an estimated five to seven years to complete.
"The fallacy here is that we will never know everything we'd like to about a drug before it goes on the market," Dr. Ray Woosley, president of the Critical Path Institute in Tucson, Arizona, said. "If we held up drugs until we did know everything a lot of people would die."
Drugs approval can be faster when they are based on biological measurements like blood sugar level in diabetics, but some medical experts believe that the FDA should not approve drugs without evidence of their improving more than just a patients’ life span.
