FDA suspects pancreatitis link with Merck’s Januvia
FDA suspects pancreatitis link with Merck’s Januvia

U. S. health officials said that they see a possible link between the blockbuster diabetes drug Januvia and cases of inflamed pancreas, but the company officials negate this relation.

FDA said that 88 cases of cute pancreatitis had been reported since the drug's approvalin 2006 through February 2009.

A number of patients noticed the development of the condition just after they started consuming Januvia or the related drug Janumet and almost more than half observed that it disappeared soon after the intake was stopped.

However, Dr. John Amatruda, a Merck senior vice president for diabetes products, said: "We don't believe that the dataestablishes a relationship" between the condition and the drugs, which both contain the active ingredient sitagliptin.

An analyst at the Deutsche Bank said that the news is unlikely to affect the sales of Januvia. Merck has announced the combined sales to reach anywhere between $2.4 billion and $2.7 billion for the two drugs.

The company is waiting for FDA's response on whether its diabetes drugs can be used along with insulin in the United States. The labels of Januvia and Janumet say that they have not been examined together with insulin.

The FDA said that it was working in collaboration with Merck to add information about the cases to the drugs' labels suggested that doctors should closely monitor their patients.

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