In September 2009, the Food and Drug Administration announced that the diabetes drug Januvia (sitagliptin) may be linked to an increased risk of pancreatitis. The agency ordered Merck, the manufacturer of the drug, to add new information about the risk of pancreatitis to the warning label for Januvia.
Pancreatitis is a serious condition caused by inflammation of the pancreas, which can lead to hospitalization and, in severe cases, death. Patients have also reported other Januvia side effects, including abdominal pain, nausea and vomiting.
Januvia was approved by the FDA in October 2006 for the treatment of type-2 diabetes symptoms. In April 2007, the agency approved a separate drug, Janumet, which combines the active ingredient in Januvia with another diabetes treatment, metformin.
According to a safety notice issued by the FDA, the agency had received at least 88 reports of pancreatitis among patients taking Januvia or Janumet. Two-thirds of these patients required hospitalization to treat the side effects they suffered after taking the drugs.
Januvia is the second diabetes drug to be linked to pancreatitis in the past two years. In August 2008, the FDA warned of a link between the drug Byetta and pancreatitis. At the time of the FDA’s warning, Byetta had been linked to at least 36 pancreatitis cases, including six cases involving a more severe form of the disease, as well as several deaths.
If you have suffered pancreatitis or other side effects of Januvia, contact the lawyers at Hissey Kientz to learn more about your legal rights. You can reach us by calling toll free at 866-275-4454, or by filling out a free case evaluation form on the right of this page.