Merck, Bristol Diabetes Drugs Linked to Pancreatitis Risk

Posted: Published on February 26th, 2013

This post was added by Dr P. Richardson

Diabetes drugs sold by Merck & Co. (MRK) and Bristol-Myers Squibb Co. (BMY) may double a users risk of developing an inflammation of the pancreas linked to cancer and kidney failure, an analysis of insurance records shows.

Patients hospitalized with pancreatitis were twice as likely to be taking Januvia, Mercks top-selling drug, or using Bristol-Myerss Byetta, than a control group of diabetics who didnt have pancreatitis, according to the analysis today in the journal JAMA Internal Medicine. Both drugs increase GLP-1, a hormone that stimulates insulin production from the pancreas.

Doctors have been concerned that this category of diabetes treatments may damage the pancreas since the U.S. Food and Drug Administration said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta. The agency issued a similar alert for Januvia in 2009. The study, which analyzed data from 2005 to 2008, showed a doubling in pancreatitis cases.

This is the first real study to give an estimate of what the risk is, until now we just had a few case reports, said Sonal Singh, the studys author and an assistant professor of medicine at Johns Hopkins University in Baltimore. These drugs are effective in lower glucose, but we should also consider the risk of pancreatitis and balance the risk versus the benefit.

Merck, the second-largest U.S. drugmaker, reported $4 billion in sales, or about 9 percent of total revenue, from Januvia last year. The daily pill blocks an enzyme that breaks down GLP-1. Janumet, which combines Januvia with the older diabetes drug metformin, generated $1.7 billion in sales last year for Whitehouse Station, New Jersey-based Merck.

Bristol-Myers, based in New York, acquired Byetta when it bought Amylin Pharmaceuticals last year for about $5 billion. Byetta, which mimics GLP-1, had sales of $148 million for Bristol-Myers last year, and $159 million for Indianapolis-based Eli Lilly & Co. (LLY), which ended its marketing partnership with Amylin in 2011.

Bristol-Myers Squibb and AstraZeneca are confident in the positive benefit-risk profile of Byetta and Bydureon as demonstrated by extensive clinical trial data and safety surveillance data, Ken Dominski, a Bristol-Myers spokesman, said in an e-mail. The companies will continue to carefully monitor any post-marketing reports of acute pancreatitis.

AstraZeneca Plc (AZN), based in London, has a partnership with Bristol-Myers on diabetes treatments. Bydureon is a longer acting version of Byetta.

Other drugs that increase the level of GLP-1 in the body include Bristol-Myerss Onglyza and Novo Nordisk A/S (NOVOB)s Victoza. The analysis only looked at Januvia and Byetta because the other treatments werent on the market during the study period. Januvia was approved in the U.S. in 2006, and Byetta in 2005.

Singh said long-term studies should be done to determine if GLP-1 therapies also increase the risk of pancreatic cancer.

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Merck, Bristol Diabetes Drugs Linked to Pancreatitis Risk

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