Pancreatitis Risk From Merck’s Januvia®: 6 In 1,000. Yawn.

As I reported, back in January 2010, Merck revised the label copy for Januvia® (sitagliptin) — with FDA concurrence — to reflect an elevated, but unquantified, risk of pancreatitis associated with taking the drug (or with taking Bristol-Myers Squibb’s Byetta®). Both affect insulin production through the patient’s pancreas.

At the time, no study had reliably quantified that risk, to an acceptable level of scientific certainty. This evening, at least one study large enough has been completed, and published in JAMA Internal Medicine — in order to quantify the risk. It turns out that similar, “normalized” patients (on other drugs) have about a 3 in 1,000 chance of developing pancreatitis. Patients taking Januvia (or Byetta) have about a 6 in 1,000 chance of developing pancreatitis.

While that is a doubling of absolute risk, it is also only a little higher than a one-in-two-hundred chance.

It is important to note that — generally speaking — the adverse health risks of non-treatment of diabetes at that level of severity far outweigh the risk of pancreatitis. so — net, net — I’d put the news tonight just slightly in the “better than originally feared” column. And Merck is rising (as expected) in after-hours trading on the NASDAQ, by about a half a percent, after being off about one per cent for most of the day, on the NYSE.

Here is a link to the Bloomberg report — do go read it all:

. . . .“This is the first real study to give an estimate of what the risk is, until now we just had a few case reports,” said Sonal Singh, the study’s author and an assistant professor of medicine at Johns Hopkins University in Baltimore. “These drugs are effective in lower glucose, but we should also consider the risk of pancreatitis and balance the risk versus the benefit.”

Merck, the second-largest U.S. drugmaker, reported $4 billion in sales, or about 9 percent of total revenue, from Januvia last year. The daily pill blocks an enzyme that breaks down GLP-1. Janumet, which combines Januvia with the older diabetes drug metformin, generated $1.7 billion in sales last year for Whitehouse Station, New Jersey-based Merck. . . .

We will keep you posted, as additional studies/analyses are completed.

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