FDA Issues "Clinical Hold" on Controversial Avandia Study
As uncertainty surrounds the safety of the popular diabetes drug Avandia, federal health officials are prohibiting new patients from enrolling in a safety study of the prescription medication because of the associated risks. The TIDE study is designed to give a definite answer to whether or not Avandia holds more risk for heart problems than similar drugs. The Federal Food and Drug Administration (FDA) issued a “partial clinical hold” on the TIDE trial, which Avandia’s manufacturer GlaxoSmithKline agreed to conduct when the drug’s safety was first questioned in 2007. However, patients who are already participating are permitted to continue.
A panel of experts recently voted that although Avandia seems to increase the risk of heart problems, the majority voted to leave it on the market. Some health professionals are arguing that the TIDE trial is unethical since there is enough evidence to prove that the drug is more dangerous. Other health professionals have speculated that Avandia will be pulled off the market soon.