In the wake of safety questions over GlaxoSmithKline's Avandia, FDA is recommending more rigorous testing of diabetes drugs for heart attack and stroke risk. The new recommendations are effective immediately, reports the Wall Street Journal, and they suggest that clinical trials should be redesigned with heart attack and stroke risk assessment in mind, and that any cardiovascular events that occur during the trial should be reviewed by independent, blinded cardiologists. Another recommendation is that the trials include older and sicker patients who should then be followed for a longer period of time.
New Recommendations for Testing Diabetes Drugs
Dec 18, 2008