A Byetta Pancreatitis Perspective

She reported that a Wall Street analyst found 24 unique cases of pancreatitis associated with Byetta from August 2005 through January 2006. Most telling to me was, “Only one of them was reported in 1Q06, which implies a decreasing incidence rate. Taken alone, the rate in 1Q06 is actually much lower than the rate of pancreatitis in the general population. This is contrary to what we would have expected since more people continue to start on Byetta over time.”

Now, of course, it’s six quarters later. In that time it looks like the FDA turned up just six more reports of such a connection.

Kelly also tellingly quoted another analyst, Thomas Wei of PiperJaffray, as saying that almost all diabetes drugs have reports of rare serious side effects. He specifically mentioned reports of pancreatitis with metformin.

In fact, just one day after the FDA’s alert on Byetta, Merck announced its own alert for another hot new diabetes drug, Januvia.
The company said it had received reports that some people taking Januvia had developed serious complications, including a potentially fatal skin condition called Stevens-Johnson Syndrome and other serious allergic reactions.

“It's not possible to establish a causal relationship,” John Amatruda, Merck’s vice president for clinical development, said in an interview. “We don’t know what other medications these patients were on.”

That’s precisely the problem. We need to keep the same perspective on pancreatitis.

More recent news about Byetta and pancreatitis is available. Read this article entitled, "FDA seeks stronger warnings for Amylin's Byetta."

For comprehensive information about Byetta, check out this site for drug facts.