Januvia and Byetta: Diabetes Drug Lawsuits

By: Gina Cucuzella

Diabetes drugs are under scrutiny by the U.S. Food and Drug Administration (FDA) after they received numerous reports of pancreatitis associated with the medications. These drugs are currently pending review, the results of which could have a dramatic effect on the millions of Americans currently being treated for Type-2 Diabetes.

Three of the major drugs currently on the watch list are Merck Pharmaceutical’s Januvia and Bristol-Meyers Squibb’s Byetta and Bydureon.

What are Januvia and Byetta?

Both Januvia and Byetta affect levels of the glucose hormone that work in conjunction with the pancreas in order to increase insulin production when food is consumed.

  •     Byetta is part of the class of drugs known as GLP-1 receptor antagonists and generated earnings approximating $490 million last year in the United States.
  •     Januvia belongs to a classification of drugs called DPP-4 inhibitors and is one of the most popular drugs of its kind, bringing in $2.67 billion last year in the United States.

The most recent statements from the FDA conclude that these new medications “may cause or contribute to the development of pancreatic cancer” however further research was requested with respect to the effect of these drugs on the pancreas.

Despite the FDA investigation and scrutiny of the drugs, both pharmaceutical giants vehemently defend their products and stand by the drugs. Merck, in talking of Januvia said that it is “confident in the safety profile,” and Bristoll, although admitting that Byetta “has been associated with acute pancreatitis, including fatal and nonfatal hemorrhagic and necrotizing pancreatitis,” they too are “confident in the positive benefit-risk profile.”

What is most upsetting about these drugs is that this information is not novel and in fact reports linking them to inflammation of the pancreas and pancreatic cancer came about as early as 2007 and was even linked to the deaths of some patients.

Doctors Concerned About Januvia and Byetta

In February of this year, the Journal of the American Medical Association (JAMA) published a study regarding Byetta, Bydureon and Januvia; the outcome of which pointed to the increased rate of acute pancreatitis associated with the drugs, which has doctors concerned. A doctor from Southmead Hospital in England, Edwin A. M. Gale is extremely worried about this issue saying that the FDA has received numerous reports and scores of data to further suggest that there is a serious problem with these drugs and their impact on the pancreas.

Pancreatitis and Pancreatic Cancer Litigation

Due to the growing amount of research and concern regarding these diabetes drugs lawsuits against Merck and Bristol-Myers Squibb are appearing nationwide. For instance, after the death of his wife from pancreatic cancer last year Plaintiff Guy Riley filed a lawsuit in California. Riley’s lawsuit claims that taking Byetta and Januvia caused not only mental and physical pain and suffering but economic loss as well. Similar lawsuits allege that side effect of the medications are “unreasonably dangerous” and the manufacturers failure to warn constitutes concealing the associated risks.

The FDA has released a statement that it “intends to obtain and evaluate” new information regarding the Januvia and Byetta drugs as well as participate in a Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in order to understand the effects it may have on patients.