Our firm recently filed suit against the manufacturers of two popular medications used to treat Type 2 Diabetes Mellitus, Januvia and Byetta. Januvia (sitagliptin phosphate) is an oral medication first brought to market by Merck and Company in 2006. Byetta (exenatide synthetic) is an injected medication first released by Amylin Pharmaceuticals in 2005, and presently manufactured by Bristol-Myers Squibb Company. Both drugs have been associated with an increased risk of pancreatic cancer and thyroid cancer, yet neither drug warns of these risks.
The human body breaks down ingested sugars and starches into glucose, which is the basic fuel that energizes cells in the body. Insulin then delivers the glucose from the bloodstream into the cells. Type 2 Diabetes is a disease whereby the body either fails to produce enough insulin to deliver the glucose, or the cells for some reason refuse to receive the insulin. This breakdown in the insulin delivery system causes the blood to accumulate unhealthy levels of glucose (hyperglycemia), which can lead to a myriad of serious and potentially life threatening diabetic complications.
Januvia and Byetta both attempt to regulate blood sugar levels by increasing insulin production by the pancreas when blood sugar is high, such as after a meal, while at the same time attempting to reduce the amount of sugar produced by the liver. But stimulating the pancreas to create additional insulin can lead to serious pancreatic inflammation, known as pancreatitis. According to a study published in 2010 in Gastroenterology, the official publication of the American Gastroenterological Association, patients taking Januvia or Byetta were six times more likely to develop pancreatitis compared to those taking other drugs. Pancreatitis is a serious condition that can be fatal. It has also been shown to be a precursor to pancreatic cancer. This study also noted a marked increase in other cancers, including thyroid cancer among sitagliptin and exenatide users. The conclusions were consistent with previous case reports and animal studies, raising caution about both short-term and long-term use of these drugs.
The Code of Federal Regulations requires a pharmaceutical manufacturer to warn of a drug’s potentially dangerous side effect “as soon as there is reasonable evidence of a causal association with the drug.” See: 21 CFR 201.57(c)(6). The manufacturers of Januvia and Byetta failed to adequately warn of the known and extremely dangerous cancer risks of these drugs and that put users at great risk. If you need more information on any of the above, contact David Dearing, a lawyer in our firm’s Mass Torts section, at 1-800-898-2034 or by email at David.Dearing@beasleyallen.com.
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