Revised information for Januvia and Janumet

The Food and Drug Administration (FDA) has asked the manufacturers of Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to revise the information that it provides the patients who take it to control their diabetes. The revision is to reflect the link between the medications and the rise in acute pancreatitis from its use.

Januvia and Janumet, both sitagliptins, are part of a new type of diabetic medication called dipeptidyl peptidase-4 (DPP-4) inhibitors. They are to be used in conjunction with a diabetic diet and exercise to control blood sugar levels in patients with type 2 diabetes. Between October 16, 2006 and February9, 2009, eighty-eight cases of patients with acute pancreatitis have been reported.

The problem with establishing the connection between the medications and the development of acute pancreatitis lies in the fact that diabetics are at risk for pancreatic diseases just by being diabetic. Type 1 diabetics use insulin injections as their body no longer can produce insulin to control blood sugar levels. Patients with Type 2 diabetes are often overweight and lack exercise to help burn off excess sugar so medications are taken to control them.

Of the eighty-eight cases of acute pancreatitis, two cases included hemorrhagic or necrotizin, more severe cases of pancreatits. The FDA has asked physicians and healthcare professionals to carefully monitor their patients and to remove them from either of these medications if there is any suspicion of pancreatitis.

Symptoms of pancreatitis include nausea, anorexia, vomiting and severe abdominal pain that may spread to the back area. It was found that almost a quarter of the cases of pancreatitis began within the first 30 days of taking either Januvia or Janumet. More than half of the cases were resolved as soon as the patients stopped taking the medications. And more than half of the cases that were reported involved patients who had additional risk factors in their medical histories, such as high cholesterol, high triglycerides and obesity that would increase their chance of getting pancreatitis.

Merck & Company is the manufacturer of Janumet and Januvia and the medications were approved by the FDA in April of 2007. Janumet was created as a more effective treatment for those with Type 2 diabetes with the combination of two powerful agents that were known to control blood sugar levels. The DP-4 inhibitors help to suppress the release of glucagons by the pancreas after a meal and the metformin works to keep the blood sugar levels on an even keel.

The medications are taken before meals usually twice a day. They are not to be used by patients with Type 1 diabetes. General side effects from taking this medication include headache, stomach pain and diarrhea but you should notify your physician if you experience any more serious reactions such as difficulty breathing and swelling of the face, throat, lips and tongue. This could reflect an allergic reaction.

At this time, physicians and patients have been forewarned of the correlation between Januvia, Janumet and acute pancreatitis and should take the necessary precautions.