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Lawsuit Alleges Wife Died From Januvia Pancreatic Cancer

A man has filed a lawsuit against Merck & Co., manufacturers of type 2 diabetes drug Januvia, in which he alleges the medication caused his wife to develop fatal pancreatic cancer.  Filed on August 12th in the United States District Court for the Southern District of California, it is the latest case to accuse Merck of failing to adequately warn the public of a link between Januvia and pancreatic cancer.

The couple at the center of the lawsuit were living in Camano Island, Washington when the deceased woman was first prescribed Januvia. According to court documents, she began using the medication in June 2005, and continued until at least January 2009. On August 13th, 2012, she was diagnosed with pancreatic cancer, although both husband and wife were unaware that it may have been caused by Januvia. She died in October 2010. In the Januvia lawsuit filed by her husband, he states that she would not have used the product had they been aware of the link between the drug and pancreatic cancer.

Januvia and similar medications like Byetta are known as incretin mimetics. They were developed to tackle the growing problem of type 2 diabetes, which is at epidemic levels, especially in the western hemisphere. Januvia and Byetta work by replicating the body’s natural production of the hormones responsible for releasing insulin into the bloodstream. These drugs are a relatively recent phenomenon, having emerged during the middle of the last decade.

Januvia is an oral incretin mimetic, and was marketed by Merck as a more convenient way of managing type 2 diabetes. Since winning FDA approval in 2006, it has become one of the top selling drugs in the United States, achieving sales of $919 million in the first quarter of 2012.

But increasingly, patients who have taken Januvia and Byetta have developed pancreatic cancer, prompting researchers to look into a possible link between the two. A German report cited in the lawsuit states that Byetta has caused an ‘unusually high number’ of cases. Published by the Drug Commission of the German Medical Association, the report found that the average period between beginning treatment with Byetta and being diagnosed with cancer was 12.2 months.

Medical journal advises caution for incretin mimetics

Online diabetes journal Diabetes Care published an article in 2010 that looked at the connection between Byetta, Januvia and pancreatic cancer. The article urged physicians to exercise extreme caution when prescribing any new diabetes treatments:

“History has taught us that enthusiasm for new classes of drug, heavily promoted by the pharmaceutical companies that market them, can obscure the caution that should be exercised when the long-term consequences are unknown… We feel that enough preliminary evidence has accumulated to suggest that there is a plausible risk that long-term recipients of [Januvia et al.] may develop pancreatic cancer.”

Diabetes drug makers consent to MDL

Earlier this month, the drug makers responsible for Januvia, Byetta and other incretin mimetics agreed to consolidate more than fifty lawsuits into federal multidistrict ligitation. The decision to look at products from several manufacturers in one MDL was because of the large number of plaintiffs who have used medication from more than one firm.

They claim that the companies responsible for making incretin mimetics knew or should have known about the link between Januvia and pancreatic cancer, and that they failed to notify physicians or patients. Legal experts anticipate increasing litigation as more Januvia deaths and cancer diagnoses emerge.

Resources

  • FDA - Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes http://www.fda.gov/Drugs/DrugSafety/ucm343187.htm