The Business Of Law

We’ve been following reported side effects from Januvia (sitagliptin) and Janumet, which is combination of sitagliptin and metformin manufactured by pharma giant Merck for over two years now, and there’s been mounting evidence to cause concern.  Just last week, the FDA finally weighed in and issued a safety alert warning of possible health risks. Read the FDA announcement here.

Specifically, FDA made revisions to the prescribing information for Januvia and Janumet to include information on reported cases of acute pancreatitis in patients using these products.

But the latest alert is not the first of the problems for the once-daily prescription tablet used to treat Type II diabetes.  In fact, concerns have been expressed linking the drug to Stevens-Johnson Syndrome and other skin reactions.  In clinical studies, patients given Januvia experienced an increase in creatine levels in the blood which is an early indicator of kidney problems.  It has also been linked to serious allergic reactions.

The pancreatitis issue first surfaced in April, when researchers at UCLA linked Januvia to low-grade pancreatitis in some patients and a greater risk of pancreatic cancer in long-term users. All told from the drugs approval in 2006 to February of 2009 88 post-marketing cases of acute pancreatitis, including 2 cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to FDA between October 16, 2006 and February 9, 2009.

In the safety report, FDA said it is working with the mfg to revise the prescribing information to include:

1)    Information regarding post-marketing reports of acute pancreatitis, including the severe forms, hemorrhagic or necrotizing pancreatitis;

2)    Recommendations that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of Januvia or Janumet and to discontinue either drug if pancreatitis is suspected while using these products;

3)    Information noting that sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis while using Januvia or Janumet.

The number of cases that we have taken on continues to increase and as always we are exploring ways to reach out to patients who may have suffered side effects associated with these pharmaceuticals if you are interested in working with us, drop me a note.