September 29, 2009

The FDA this week announced that sitagliptin, an ingredient contained in the type 2 diabetes drugs Januvia and Janumet, may be linked to an increased risk of pancreatitis. According to the agency, 88 cases of acute pancreatitis with people taking Januvia and Janumet were reported to the FDA’s Adverse Event Reporting System between October 2006 and February 2009.

Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, the FDA is making revisions to the Januvia and Janumet prescribing information to alert patients and healthcare professionals to this potentially serious side effect.

Merck, the company that markets Januvia and Janumet, claims its data shows no increased risk of pancreatitis from Januvia and Janumet. “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.”

But this isn’t the first time the FDA has found a potential link between a new-line diabetes drug and pancreatitis. Not long ago, Byetta also found itself under FDA scrutiny after reports of pancreatitis, including several deaths, were made to the agency. Since then, around 110 plaintiffs have sued Byetta’s makers, Eli Lilly and Amylin Pharmaceuticals, for injuries allegedly caused by the drug.

Symptoms of Januvia & Janumet Pancreatitis

While the FDA says that patients should not stop taking Januvia or Janumet without first speaking to a doctor, the agency recommends that patients pay close attention for any signs or symptoms of pancreatitis. Januvia side effects and Janumet side effects that may be associated with the development of pancreatitis include nausea, vomiting, anorexia, and persistent severe abdominal pain, sometimes radiating to the back. Patients who experience any of these side effects while taking Januvia or Janumet should contact a medical professional immediately

Januvia & Janumet Lawsuit Information

If you or a loved one has experienced Januvia pancreatitis or Janumet pancreatitis, you may be entitled to compensation for your medical bills, lost wages and other injuries. For information about filing a Januvia lawsuit or Janumet lawsuit, contact one of Bernstein Liebhard’s skilled trial attorneys for a free and confidential case evaluation.

Published November 17, 2011 by