Hey, Food and Drug Administration! We all know that drugs
can cause side effects in some patients. Can we just move
on?
No?
I was afraid of that.
The agency's latest victim:
Merck 's (NYSE: MRK) Januvia and Janumet, the
latter of which combines Januvia with another diabetes drug,
metformin. On Friday, the FDA said  it had
received 88 reports of pancreatitis in the nearly two and a
third years after Januvia was approved. So that's 88 out of
how many people taking the drug? And how many of them would
have gotten pancreatitis anyway? Those are the $2.4 billion
(annually) questions.
In controlled trials with more than 6,000 patients, Merck
says it hasn't seen any meaningful increases in pancreatitis
over placebo. Keep in mind that diabetics have an increased
risk of getting pancreatitis, so a controlled experiment is
definitely the way to go.
The same problem of reported cases of pancreatitis in
people taking
Amylin Pharmaceuticals (Nasdaq: AMLN) and
Eli Lilly 's (NYSE: LLY) Byetta
sank salesof their drug. Byetta and Januvia work in
different ways, but ultimately on the same pathway, so it's
possible there's a connection. If that's the case, then we'll
have to throw
AstraZeneca (NYSE: AZN) and
Bristol-Myers Squibb 's (NYSE: BMY) new
diabetes drug, Onglyza, into the mix, as it's in the same
class as Januvia.
From a clinical perspective, the problem with all these
early warnings from the FDA is that patients and doctors may
become desensitized to them.
For the companies, that might not be such a bad thing.
It's not hard to imagine that the Januvia warning could
actually increase sales of Byetta, as doctors who have had
good experiences with Januvia, without any cases of
pancreatitis, might also discount the potential pancreatitis
issues with Byetta.
That's one side effect of these warnings that Amylin and
Eli Lilly wouldn't mind seeing.
This article was originally published as
Here We Go Again With Possible Side Effectson
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