• blog 2010 04 26 januvia side effects raise concern over possible link pancreatitis

In September 2009, the U.S. Food and Drug Administration added information regarding a possible link between the prescription medication Januvia and acute pancreatitis to the drug’s label. Manufactured by Merck, Januvia features the main ingredient sitagliptin, which aids glycemic control in favor of diet and exercise in adults with type-2 diabetes. The FDA decision was a recommendation for doctors to exercise additional care in patients that are newly prescribed with Januvia or the similar medication Janumet, as well as patients with a history of pancreatitis.

Leading up to the decision, the FDA examined the cases of 88 patients with acute pancreatitis that were also using Januvia or Janumet over a four-year period. Two-thirds of the patients had been hospitalized with the ailment, and four of those patients had to be treated in the ICU. According to the FDA, 19 of the cases of pancreatitis developed within 30 days of the patients beginning use of either drug. Additionally, more than 45 of the patients experienced remission of pancreatitis after they stopped taking either drug. This information led the FDA to make its decision to issue the label warning.

Merck disagreed with the assessment then and still maintains that the findings were contradictive with the pharmaceutical giant’s own findings. According to a Merck statement coinciding with the FDA’s report, the company had studied 6,000 patients over a two-year period and did not find that sitagliptin increased the risk of developing pancreatitis in users of Januvia.

The pancreas assists the body in digestion, and releases insulin and glucagon. When the pancreas becomes inflamed, acute pancreatitis has developed and can be a very serious – in some cases life-threatening – disease if not treated properly. In most cases, however, it can disappear after a week. The main symptom of acute pancreatitis is severe abdominal pain, with additional symptoms being jaundice, anxiety, fever, nausea, and vomiting.

More serious alleged side effects reported for Januvia include sweating, shaking, severe hunger, dizziness, cold sweats, blurred vision, changes in mood, loss of balance, difficulty speaking, confusion, and seizures. More common side effects include respiratory infections, sore throat, nausea, diarrhea, headaches, and stomach pains.

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 Newsome Law Firm and fill out a case evaluation form 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.