FDA sees pancreatitis link with Merck's Januvia

WASHINGTON, Sept 25 (Reuters) - U.S. health officials said on Friday they suspect Merck & Co Inc’s (MRK.N) blockbuster diabetes drug Januvia may be linked to serious cases of inflamed pancreas, but company officials disputed the connection.

The Food and Drug Administration said that 88 cases of acute pancreatitis had been reported since the drug’s approval in 2006 through February 2009.

More details:

There’s no data reporting the number of acute pancreatitis cases before the drug was approved.

I understand that there’s a relationship between the start of Byetta and pancreatitis too. I (with a history of pancreatitis 3X related to gallstones & ERCP) was prescribed Metformin after stopping a short trial of Januvia with no adverse side effects. I learned of the Januvia cancer & pancreatitis connection months ago from this website. (Noteably, Byetta’s origin is in the saliva of the Gila Monster and there’s documented pancreatitis associated with that animal’s bite. Plus, lactoc acidosis (and pancreatitis) is a rare serious side effect associated with Metformin, hypos are associated with insulin and sulfonylureas, and heart failure and edema with TZDs.) Ooooppss…I’m rambling.

Regarding Januvia you wrote “There’s no data reporting the number of acute pancreatitis cases before the drug was approved.” The FDA didn’t seem to find a relationship between Byetta and pancreatitis; I understand that Byetta got through the FDA w/o a panel review.

Thanks, Lucile. My post was incomplete for some reason. I meant to say that we need more information about the incidence of panreatitis over the years and see if there are any sudden increases after introduction of drugs like Januvia. I’m sure that data is out there but I don’t know how to get it.

I am a person who takes minimal risks and with this drug there are too many risks even outside of the pacreatitis issue. The way I see it, this drug came out too quickly and it should have been researched further. I was on this medication for six months and it turned my world upside down. Also I think doctors are too quick to give out new meds when the old ones work just fine or old methods. I am not saying we should just stick to old ways and not make progress but we should be very well educated before we put something in our bodies. We should be warned of all the possible side effects and how a medicine may impact our health based on previous medical history.

One more thing, I read the article and Merck is pushing their wonder junk to be used with insulin. What is the point of using a pill when insulin alone can do the job. If I have to take insulin for type 2, I am not going to pop a pill with side effects when insulin alone would do the job.

Hi wil v, John Smith, Manny and everyone:
So how many years should a new drug be around before considering taking it? I agree with wil v about taking minimal risks with medications; hence, I stopped taking Januvia several months ago. However, rare adverse side effects happen but seemingly don’t add up until after many patients are prescribed a new drug. That is, if a side effect is actually asociated with the start of a new drug, the rate of the side effect will increase over time as more patients start the drug. So I guess all us minimal risk takers shouldn’t consider taking a new drug until it’s been prescribed for XX years. (XX = how many years, ten?) Best regards, Lucy