Restrictions On Avandia (Rosiglitazone) Should Be Loosened, Says FDA Panel

Most of the 26-member advisory FDA panel voted to loosen the restrictions which were placed on GSK's diabetes drug Avandia (rosiglitazone) in 2010 because of concerns it might raise the risk of heart attacks and death from cardiovascular causes. Seven panel members voted to remove all the restrictions, stating that the evidence for heart attack risk was not compelling, while five voted to leave the restrictions as they are. Thirteen voted to loosen the restrictions, e.g. not requiring patients to sign an informed consent form or to register...
Source: Health News from Medical News Today - Category: Consumer Health News Tags: Regulatory Affairs / Drug Approvals Source Type: news