updated 9/25/2009 7:21:58 PM ET 2009-09-25T23:21:58

The Food and Drug Administration said on Friday that there may be a connection between Merck & Co.'s diabetes treatment Januvia and occurrences of acute pancreatitis, the same issue that sunk sales of Amylin Pharmaceuticals Inc.'s Byetta.

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Still, the agency reaffirms it is unclear whether the connection is between the treatment and pancreatitis or whether diabetes patients in general are at an increased risk.

The FDA said there were 88 cases of acute pancreatitis reported in Januvia patients between October of 2006 and February of 2009. The agency is working with Merck to include new warning information on the drug's label.

"It is recommended that health care professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases," the agency said, in a statement.

The agency said the medication should be used with caution and with appropriate monitoring in patients with a history of the condition.

Acute condition linked to severe illness, death
"Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, FDA is recommending revisions to the prescribing information to alert health care professionals to this potentially serious adverse drug event," the agency said.

Dr. John Amatruda, senior vice president and head of Merck's diabetes and obesity unit, said the company voluntarily updated the drug's label in March because of postmarketing reports. He also said it is not possible to establish a link based on the reports, citing a range of variables. Those include whether diabetes patients have other conditions.

"Patients with type 2 diabetes are more likely to develop pancreatitis than other people, and as the FDA noted in a publication earlier this year, 'diagnosis of drug-induced pancreatitis poses a challenge since it can be difficult to rule out other causes,'", Amatruda said.

He added that Merck encourages any patients with concerns to speak with their physician.

Sales of Amylin's injectable, twice-daily Byetta fell sharply in 2008 after the drug was linked to cases of acute pancreatitis. Prescriptions have since stabilized, and the San Diego company has said an epidemiology study showed there was no increased incidence of pancreatitis associated with Byetta compared with other diabetes treatments.

Worldwide sales of Januvia rose 38 percent in the second quarter to $462 million.

Shares of Whitehouse Station, N.J.-based Merck rose 42 cents to $31.43 in afternoon trading.

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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