Januvia Lawsuit

On September 25, 2009 the Federal Drug Administration issued a statement to doctors and consumers about a revision being made to the warning label of the drug Januvia or Janumet, a combination drug comprised of Januvia and Metformin. The warning label informs users of the possibility of developing two severe forms of acute pancreatitis, including necrotizing pancreatitis and hemorrhagic pancreatitis.

Januvia – also known as sitagliptin – is prescribed in the treatment of type-2 diabetes, however it has recently been linked with side effects of acute pancreatitis. The FDA’s Adverse Event Reporting System lists approximately 88 cases of acute pancreatitis occurring between October 2006 and February 2009. The FDA’s list could represent as little as 10 percent of the actual cases of acute pancreatitis among prescribed users of Januvia.

FDA Information on Januvia

  • 66 percent of the 88 cases reported required hospitalization for pancreatitis

  • Four patients were treated in intensive care units

  • Two of those hospitalizations featured acute pancreatitis conditions of necrotizing and hemorrhagic pancreatitis that can result in death

  • 21 percent of the patients developed pancreatitis within 30 days after taking Januvia or Janumet, resulting in hospitalization

  • 53 percent of the 88 cases of pancreatitis reversed when the use of the medication was stopped

  • 49 percent of the cases had no other health problems with risks to developing pancreatitis. 51 percent of the cases had a least one other risk factor such as obesity, diabetes, high cholesterol and/or high triglycerides.

  • The pancreatitis symptoms that were most common in the 88 cases were nausea, abdominal pain, and vomiting.

The FDA drew the conclusion that the relationship between Januvia or Janumet and the occurrences of acute pancreatitis required amendments to the medication marketing and warning labels. While it is not certain or matter of fact that Januvia causes acute pancreatitis, an association has been made between the two, with pancreatitis being a potentially fatal disease.

Manufacturer Liability and Response

Januvia’s manufacturer, Merck & Co. Inc., are being accused of failure to post information regarding the possibility of pancreatitis as a major side effect of the medication. Merck, however, has maintained that the drug is safe for use by diabetics and does not cause acute pancreatitis, having cited company-sponsored research that shows statistics and results that differ from the results of the FDA’s study.

The FDA did not recommend discontinuing the use of Januvia or Janumet, especially since diabetes medications should only be discontinued under the supervision of a doctor. Users of Januvia and related drugs should consult with their physicians about continued use.

Symptoms of Pancreatitis

  • Severe pain in the upper abdominal area that may also spread to the back

  • Nausea with vomiting

  • Blood pressure that is high or low

  • Rapid heartbeat or breathing

  • Anorexia

Doctors and patients are advised to look for any of these symptoms after the drug is administered. Doctors are to discontinue the medication if symptoms of pancreatitis are present and begin supportive medical care along with appropriate lab tests. Prescribed users of Januvia should alert their physicians immediately if they experience symptoms of pancreatitis.

As 21 percent of the 88 cases occurred within the first 30 days of starting Januvia, this time period should be a time of close monitoring for symptoms.

If you or a loved one are a prescribed user of Januvia or Janumet and have experienced serious side effects or symptoms of acute pancreatitis, contact us for a case evaluation today. Our team of attorneys has experience specific to complications associated with the side effects of prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.