LEGAL GUIDE
Written by Avvo Staff | Jul 21, 2010

Dangerous Drug: Januvia and Janumet Risks & Lawsuit Information

Januvia, also known as Sitagliptin, is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in patients with type 2 diabetes. Janumet is also used to treat type 2 diabetes and combines the active ingredient in Januvia, with another ingredient, Metflorim.

While taking Januvia or Janumet, it is important to have your blood tested regularly to monitor any adverse side effects that may occur while taking this drug. Additionally, your doctor may prescribe kidney tests as well.

Adverse Risks Associated with Januvia and Janumet

Some serious side effects associated with Januvia and Jaumet include:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); fever, chills, or persistent sore throat; red, blistered, swollen, or peeling skin; and acute pancreatitis which is the swelling and inflammation of the pancreas. Pancreatitis symptoms may include: severe abdominal or back pain with nausea or vomiting, stomach tenderness or swelling, and fever and chills.

It has also been reported in rare cases that Januvia has caused a serious and sometimes fatal condition called lactic acidosis, this is when lactic acid builds ups in the blood stream faster than it can be removed. Most of these cases have occurred in diabetic patients who also have certain kidney problems. The risk of lactic acidosis may be greater if you have liver or kidney problems or heart disease. The risk may also be greater in patients who are elderly or who drink alcohol.

Some of the less serious side effects people have developed while taking Januvia or Janumet include the following:

  • Nausea
  • Vomiting
  • Loss of appetite
  • Sore throat
  • Diarrhea
  • Headache
  • Abdominal pain
  • Runny or stuffy nose, sore throat
  • Upper respiratory infection
  • Upset stomach

Januvia and Janumet Lawsuits and Disputes

The FDA received 88 reports of acute pancreatitis with people taking Januvia and Janumet between October 16, 2006 and February 9, 2009. Some of the reports involved severe forms of pancreatitis, such as hemorrhagic pancreatitis (inflammation of the pancreas with bleeding) and necrotizing pancreatitis (in which the inflamed pancreas destroys itself).

After reviewing the reported cases of Januvia and Janumet pancreatitis, the FDA states that they found that 19 (21%) of the 88 cases occurred within 30 days of starting Januvia or Janumet. The FDA also found that 47 (53%) of the 88 cases resolved themselves after Januvia or Janumet were discontinued. Based on these findings, the FDA says it believes there may be an association between Januvia, Janumet, and the development of pancreatitis.

Because acute pancreatitis is associated with considerable illness and possible death, and early detection is important in reducing adverse affects, the FDA is making revisions to the Januvia and Janumet prescribing information to alert patients and healthcare professionals to this potentially serious side effect.

Getting Legal Help

Product liability lawyers are closely monitoring the FDA adverse event reports involving Januvia and Janumet and pancreatitis. The potential for Januvia and Janumet lawsuits are being considered for individuals who have been diagnosed with acute pancreatitis, hemorrhagic pancreatitis or necrotizing pancreatitis. Settlements from lawsuits may be sought against the drug manufacturer to compensate for harm caused by their products. If you feel you've been seriously harmed from either of these drugs, you should contact a product liability lawyer to evaluate your case.

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