The FDA said today that Merck’s diabetes drug Januvia may be associated with pancreatitis , a serious inflammation of the pancreas that can lead to hospitalization and, in rare cases, death. Merck said that the data suggest the drug doesn’t cause pancreatitis. This is the second time in just over a year that a popular, new-ish diabetes drug has been linked to pancreatitis — the previous case was Byetta, which is co-marketed by Amylin and Eli Lilly. In that instance, several deaths were reported. The FDA said today it had received 88 reports of pancreatitis in patients taking Januvia and Janumet, a related drug that combines Januiva with the diabetes medicine metformin. The agency didn’t report any deaths in cases of pancreatitis in patients taking the drugs, but 66% of the cases did require hospitalization. In 21% of cases, pancreatitis occurred within 30 days of starting Januvia or Janumet; 53% of the cases resolved once after the drug was discontinued. Merck said that data

from clinical trials that included more than 6,000 people, as well as reports that have emerged since the drug has been on the market, don’t show an increased risk of pancreatitis associated with Januvia. The statement notes that simply having diabetes increases the risk of the disorder. Amylin and Lilly have been named as defendants in Byetta cases brought by 110 plaintiffs in cases primarily related to pancreatitis, Amylin said in its most recent quarterly report. Byetta sales fell slightly in the first half of this year, to $332.8 million from $336 million in the year-earlier period. Byetta and Januvia are different classes of drugs. But they work in related ways. Januvia slows the breakdown of a hormone known as GLP-1 and a related hormone; Byetta mimics naturally occurring GLP-1. Merck’s sales of Januvia and Janumet totaled more than $1 billion in the first six months of this year.

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Another Diabetes Drug is Linked to Pancreas Inflammation