Merck's Diabetes Drug Januvia Linked to Increased Pancreatis Risk

September 28, 2009

Brought to you by The Best Years in Life

By Susan Heavey

WASHINGTON, Sept 25 (Reuters) - U.S. health officials said on Friday they suspect Merck & Co Inc's (MRK.N: Quote, Profile, Research) blockbuster diabetes drug Januvia may be linked to serious cases of inflamed pancreas, but company officials disputed the connection.

The Food and Drug Administration said that 88 cases of acute pancreatitis had been reported since the drug's approval in 2006 through February 2009.

Because a number of patients developed the condition soon after taking Januvia, or related drug Janumet, and more than half saw it disappear after they stopped using it, "FDA believes there may be an association" with the drug.

Of the reported cases, 19 patients saw problems within 3 days of the drugs' use, and 47 cases resolved after use of Januvia or Janumet was discontinued, the agency said.

But Dr. John Amatruda, a Merck senior vice president for diabetes products, said: "We don't believe that the data establishes a relationship" between the condition and the drugs, which both contain the active ingredient sitagliptin. Patients with diabetes are twice as likely to develop pancreatitis even without medication, Amatruda said.

Several other rival products, including Amylin Pharmaceuticals Byetta, have also been linked to an increased risk of pancreatitis, which can be deadly if not treated.

Tony's note: And we know we can trust Merck when they assure us of a drug's safety don't we. Vioxx, Fosamax, Avandia, Gardasil . . . .