Concerns are growing that Byetta, Amylin and Eli Lilly’s injectable treatment for Type 2 Diabetes, may be associated with cancer, especially thyroid and pancreatic cancer. At least one Byetta cancer lawsuit has already been filed, claiming the drug caused a Florida man to develop fatal liver and pancreatic cancer.
Byetta was approved in 2005 to help Type 2 Diabetics on other medications better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels. Byetta was later approved as a stand-alone therapy for type 2 diabetes.
Byetta has been linked to a number of serious side effects, including pancreatitis (which when chronic, can lead to pancreatic cancer). In August 2008, the U.S. Food & Drug Administration (FDA) and the drug’s makers announced six patients taking Byetta had died from pancreatitis. When the FDA approved the expanded use of Byetta, it also announced that the drugâ€™s prescribing information would warn about the risk of pancreatitis in patients with severe kidney disease. In November 2009, the agency approved a new label for Byetta amid reports the medicine may cause kidney problems.
In December 2009, it was learned that the drugâ€™s makers had been directed by the FDA to conduct a number of Byetta post-marketing studies. These included one that would explore a possible association with pancreatic cancer and thyroid neoplasm (this often refers to thyroid cancer).
The Byetta cancer lawsuit filed in Florida involves a Byetta user who succumbed to liver and pancreatic cancer in January 2008, just five months after beginning treatment with the drug. The man’s widow sued Amylin Pharmaceuticals and Eli Lilly for negligence, failure to warn, and loss of consortium. The lawsuit alleges the drug companies negligently marketed and promoted Byetta, and breached warranty by failing to adequately test it or warn consumers of its dangers. It further alleges that the defendants overstated Byetta’s benefits and downplayed its risk, especially regarding pancreatitis.
There are also concerns about a potential link between Byetta and thyroid cancer. The FDA first raised this possibility in a report it issued in 2010 which said another drug in this class – Victoza – had been associated with thyroid tumors. The agency said that strict label warnings may be necessary to alert users of Byetta and other drugs in its class about this potential side effect.