FDA warns diabetes drug Byetta may have dangerous side effect

FDA warns diabetes drug Byetta may have dangerous side effect

“One has to openly wonder if the FDA has a clue to what it’s doing.”

That no-gray-areas quote isn’t mine (although I completely agree). David Kliff, editor of Diabetic Investor, made the remark in a recent issue of Forbes where he took the FDA to task for issuing a warning about Byetta, a type 2 diabetes medication.

Kliff argues that FDA officials overreacted when they announced last month that six cases of hemorrhagic or necrotizing pancreatitis have been linked to Byetta use. All six of the patients were hospitalized and two of them died.

The FDA recommends that Byetta be discontinued if pancreatitis is suspected.

But Mr. Kliff has a different take. He notes that six pancreatitis cases among one million Byetta users actually compares favorably to the yearly average of six pancreatitis cases per 20,000 people that develop in the general population. And this is especially significant in that type 2 diabetics are at greater risk for pancreatitis anyway.

So does Byetta actually reduce pancreatitis risk? Mr. Kliff stops short of making that claim, but he notes that the medication provides superior glucose control while also helping patients lose weight. And sure enough, the Byetta website notes that loss of appetite is one of the common side effects – along with nausea, vomiting, diarrhea, acid stomach, dizziness, and feeling jittery.

How could you NOT lose weight?

Finally, Mr. Kliff asks, “Just what does the FDA expect patients and physicians to do now?”

Well, they didn’t ban the drug, so I’m pretty sure they expect patients to keep right on taking it. That would be the FDA way. But patients taking Byetta who are uncomfortable with those daunting “common” side effects (as well as the possibility of hemorrhagic or necrotizing pancreatitis) might be interested in a free HSI report titled “Diabetes Defeated” which offers tips on much safer ways to help manage glucose control.

Sources:
“Byetta (exenatide)” FDA, 8/18/08, fda.gov
“Bumbling Over Byetta” David Kliff, Forbes, 8/19/08, forbes.com