Virginia resident files lawsuit against San Diego-based diabetes drug maker

In the first lawsuit of its kind, a Virginia resident has filed a lawsuit against the maker of the diabetes drug called Byetta. The lawsuit charges that the drug maker has failed to adequately test and monitor the side effects of Byetta.

The lawsuit was filed by Victor Deleon in the San Diego Superior Court. The lawsuit charges the San Diego-based Amylin Pharmaceuticals, Inc., and the drug’s co-marketer, Eli Lilly and Company. Deleon was hospitalized in December of 2007 after developing the condition, which causes inflammation of the pancreas and can lead to bleeding and death.

The lawsuit seems to be another major disaster to the drug maker. Prior to that the company was accused by the FDA of having received six reports of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since October of 2007.
Two of the six patients died. In a press release, the FDA said it is “working with the maker of Byettato add “stronger and more prominent warnings” to the product’s label.

In language of the lawsuit, the patient alleges that the drug maker has, “failed to adequately warn prescribing physicians of the risk of pancreatitis, of measures needed to properly assess the appropriateness of prescribing the drug to certain categories of patients, and of measures doctors and patients could and should take to minimize the risk.”

In the fall of 2007, Amylin agreed to add information about pancreatitis to the precautions section of the Byetta label after the FDA reported 30 post-marketing reports of acute pancreatitis associated with the drug.



Leave a Reply

Protected by Comment Guard Pro