The FDA is working on a new warning label for Byetta a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co.
This comes as The Food and Drug Administration said Monday it has received six additional reports of patients developing a dangerous form of pancreatitis while taking Byetta. Two of the patients died and four were recovering.
Last October the FDA issued an alert about 30 reports of Byetta patients developing pancreas problems. At that time Byetta’s makers agreed to add information about the reports to the drug’s label.
This is an example of how dangerous side effects of certain medications are not evident until after the FDA has approved the drug. If Wythe vs. Levine were to be successful, there will be no legal remedy for the damages incurred.