Concerned by post-marketing cases of pancreatitis, FDA is adding the reports to labeling on Merck's (MRK) diabetes drug Januvia (sitagliptin) and a combo form of the drug, Janumet. The agency is recommending that doctors monitor their patients after starting them on either drug, and after increasing their doses. Plus, the new labeling will point out that Januvia hasn't been studied in patients with a history of pancreatitis, so doctors should be extra cautious about using the drug in those people.
FDA says it has reviewed 88 cases of acute pancreatitis in patients using Januvia or Janumet, reported between October 2005 and February of this year. Some 66 percent were hospitalized, with four admitted to ICU. Nineteen of the 88 cases occurred within 30 days of starting one of the drugs, and more than half of the 88 cases cleared up once the drug was stopped. "Based on the temporal relationship... FDA believes there may be an association," the agency said on its website.
Merck, however, said its data don't show an increased risk of pancreatitis from Januvia. "Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients," Senior VP DR. John Amatruda said in a statement. "Merck has also carefully reviewed post marketing adverse experience reports, and Merck believes these data do not demonstrate that a causal relationship exists between sitagliptin and pancreatitis."
This isn't the first time FDA has spotted a potential link between a new-line diabetes drug and pancreatitis. The Eli Lilly/Amylin Pharmaceuticals drug Byetta also found itself under agency scrutiny after reports of pancreatitis, including several deaths. Since then, Byetta sales have fallen slightly, and as the Wall Street Journal Health Blog points out, some 110 plaintiffs have sued the companies over Byetta, with most of those cases related to pancreatitis.
- see the FDA statement
- read the release from Merck
- check out the Health Blog post
- get more from Reuters
ALSO: Merck got a positive opinion from European drug regulators for Januvia as an add-on to insulin in treating type 2 diabetes. Release