Point of Byetta Study? Warning is Still Needed

July 13th, 2010. By AbiK

Despite a recent study that puts into question the link between Byetta and pancreatitis, I was looking back over Byetta’s history as it relates to FDA labelling. For some background, Byetta came on the market in 2005—to treat patients with type-2 diabetes—and some reports indicate that over 10 million Byetta prescriptions have been written since 2005.

But since 2005, there have been some other interesting (or should I say “disturbing”) developments with Byetta as well. According to the FDA, between April 28, 2005 and December 31, 2006, there were 30 domestic reports of acute pancreatitis in patients who were taking exenatide (the generic name for Byetta). Clearly feeling that thirty such cases within the span of just under two years was perhaps worth raising an eyebrow, the FDA responded with some additional Byetta warnings. Here’s what happened:

October, 2007: the FDA mandated that Amylin and Eli Lilly include stricter, more prominent warning labels about possible Byetta side effects on Byetta’s packaging; the new Byetta warnings included acute pancreatitis.

August, 2008: the FDA issued an alert to healthcare providers regarding six additional cases of necrotizing or hemorrhagic pancreatitis among Byetta patients. Two of those six cases resulted in death.

November, 2009: Between April, 2005 and October, 2008, the FDA had received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Based on this, the FDA issued new safety information on Byetta to include a warning of possible kidney function problems a a side effect.

Now, while I surely don’t believe the FDA is incapable of error or misjudgement (we only have to look to Avandia this week to question such), it does seem that when the number of reports hitting the FDA’s AERS database rises above double digits in a fairly short amount of time that one should take pause. And this latest study—which basically found that the risk of acute pancreatitis is no greater with Byetta than other diabetes drugs in its class and that diabetics are more prone to such—seems a bit like saying well, we know that Budweiser beer (and no, I’m not picking on Budweiser—consider it a fine job of brand name retention tactics from their marketing team) can get you drunk like other beers, so what’s the problem if I down a 12-pack of Bud or of Coors? The fact that something is no worse than something in its class doesn’t quite absolve it in my book. The hangover stills greets you in the morning.

Another thing I’m not loving about this latest Byetta study is that it was not done as a randomized clinical trial—it was done via observation. Observation of Medco’s (yes, the pharmacy benefit management company whose prescription card you may well be carrying in your wallet) pharmacy and medical claims data. So the population was a rather non-random bunch. And, I might add that while there were declarations of there being no incentive etc etc, Byetta is one of the covered brand-name drugs on Medco’s standard formulary list—which as Reuters points out is the “list of preferred drugs.”

Call me jaded, but I’d like an independent source to conduct a clinical trial on this. I’m certainly happy for all the Byetta patients out there if there is ultimately no real measurable correlation between Byetta and pancreatitis and kidney problems. That would good news. But unfortunately I left my rose-colored glasses at the beach last weekend.

Tags: Byetta, FDA, Kidney Function, Medco, Pancreatitis

This was posted on Tuesday, July 13th, 2010 at 4:11 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.