Januvia, Byetta double pancreatitis risk, JAMA analysis finds
| By Tracy Staton |
The diabetes treatments Januvia and Byetta may double patients' risk of pancreatitis, a new study finds. The drugs, sold by Merck and a Bristol-Myers Squibb/AstraZeneca partnership, have been linked to pancreatitis
before, but the JAMA Internal Medicine study puts a number to that risk for the first time.
Researchers analyzed insurance records to find that patients
hospitalized with pancreatitis were twice as likely to be using Januvia
or Byetta, when compared with diabetics who didn't have pancreatitis, Bloomberg
reports. "This is the first real study to give an estimate of what the
risk is," said study author Sonal Singh, assistant professor at Johns
Hopkins University. "[U]ntil now we just had a few case reports."
It was on the basis of those case reports that the FDA issued safety
alerts for both drugs. In 2007, the agency flagged pancreatitis cases in
Byetta patients, and did the same for Januvia in 2009. In 2008, the FDA
amped up label warnings on Byetta after 6 deaths in patients who had
developed pancreatitis, though four of them couldn't be causally linked
to the condition. Besides the risks of acute pancreatitis itself, the
condition boosts the risk of pancreatic cancer.
Both companies defended their drugs' safety. Merck told Bloomberg
that it has reviewed the data and found "no compelling evidence of a
causal relationship" between Januvia and pancreatitis or pancreatic
cancer. Bristol-Myers said it and AstraZeneca are confident in the
"positive benefit-risk profile" of Byetta and its long-lasting
formulation Bydureon, and promised to "continue to carefully monitor" post-marketing reports.
Merck's Januvia franchise is a whopper. The drug itself brought in $4 billion for Merck last year. Its sister combo treatment, Janumet,
which combines Januvia with the common diabetes drug metformin, added
another $1.65 billion. Merck recently gave up developing a combination
of Januvia and the now-off-patent Lipitor.
Byetta is less lucrative for Bristol-Myers and AstraZeneca, with $148
million in 2012 sales (and another $159 million for Eli Lilly under its marketing partnership). But one reason Bristol-Myers bought Amylin Pharmaceuticals was Byetta. The drugmaker figured it and AZ could apply their Big Pharma marketing power to pump up the drug's sales.
- read the Bloomberg story
