A South Carolina woman has filed a product liability lawsuit against Amylin Pharmaceuticals and Eli Lilly & Co., alleging that she developed pancreatic cancer from Byetta.
The complaint (PDF) was filed last month by Vickie Lankford in the U.S. District Court for the Southern District of California, alleging that the drug makers failed to adequately warn users or the medical community about the risk of damage to the pancreas caused by the type 2 diabetes drug.
According to allegations raised in the Byetta lawsuit, Lankford was diagnosed with pancreatic cancer in February 2010, after using the injectable diabetes medication for about four years.
Lankford indicates that she just learned of the link between Byetta and pancreatic cancer shortly before the complaint was filed, but alleges that the manufacturers knew or should have known about the potential side effects of Byetta since the medication was introduced in 2005.
Studies, Reports, Link Byetta to Pancreatic Cancer, Pancreatitis
Byetta (exenatide) is an injectable medication that is part of a new class of diabetes drugs used to control blood sugar levels. Known as an incretin mimetic, the Byetta pen imitates natural hormones that lower blood glucose levels.
In recent years, FDA adverse event reports have raised concerns about a link between Byetta and pancreatitis, including severe cases of necrotizing pancreatitis and hemorrhagic pancreatitis, which have resulted in several deaths.
Pancreatitis is a substantial risk factor for the subsequent development of pancreatic cancer, due to the chronic inflammation and increased cell turn over, and Lankford alleges that Amylin and Eli Lilly concealed their knowledge that Byetta increases the risk of cancer, with the manufacturers not even mentioning “pancreatic cancer” in the Byetta warning label.
“As a result of the defective nature of Byetta, persons who were prescribed and ingested Byetta for even a brief period of time…were at increased risk for developing life-threatening pancreatic cancer,” according to the complaint. “Once that cancer spreads, a patient stands just a 1.8% chance of surviving longer than five years.”
The lawsuit accuses the manufacturers of failure to warn, desiging a defective product, negligence, breach of warranty, negligent misrepresentation, and fraudulent concealment. The lawsuit seeks both compensatory and punitive damages.
FDA Investigating Byetta Pancreas Cancer Risk
Earlier this month, the FDA launched an investigation into the risk of pancreatitis and pancreatic cancer from Byetta, as well as other incretin mimetics, such as Januvia and Victoza.
The FDA is evaluating the findings of an unpublished study that examined pancreatic tissue taken from users after they died, which suggested that patients treated with incretin mimetics face an increased risk of pancreatitis and pre-cancerous cellular changes, known as pancreatic duct metaplasia. The FDA has asked the researchers for information on the methodology to collect and study these specimens, as well as for tissue samples so the agency may further investigate the potential pancreatic toxicity with Byetta, Januvia and Victoza.
Concerns about the risk of pancreatic cancer and pancreatitis from Byetta and Januvia was further heightened by a study published last month in JAMA Internal Medicine. The study suggested that taking the medications may double the risk of hospitalization due to pancreatitis and researchers expressed concern that this may ultimately caused some users to develop pancreatic cancer.