On Wednesday, November 13, 2007, the U.S. Food and Drug Administration made public that they will require the diabetes drug Avandia to carry a “black box” warning saying that the drug could cause chest pain or heart attacks. The company will begin trial comparing Avandia to other rival drugs and placebo to see if the risk is unique to Avandia.
FDA’s Dr. Janet Woodcock told reporters that they are keeping the drug on the market because there is not enough evidence that the risk of heart attack is higher than that of other diabetes drugs. However, the following was also reported:
The top-selling diabetes drug has been under scrutiny since a U.S. analysis last May linked Avandia to a 43 percent higher risk of heart attack in patients.
It seems clear that further testing must be done quickly to determine whether or not Avandia is a safe drug. The FDA is advising doctors to closely monitor their patients in the meantime.
For more information on this subject, please refer to the section on Drugs, medical Devices, and Implants.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.