An article on Minyanville today has some drawbacks of...

An article on Minyanville today has some drawbacks of Byetta,

http://www.minyanville.com/businessmarkets/articles/byetta-lar-fda-victoza-kidney-pancreatits/3/10/2010/id/27229

The original formulation of Byetta, a twice-daily injection, has been on the market since 2005 and has helped millions of type-2 diabetes sufferers control their blood sugar; it was the first of its class in diabetes drugs. (A second drug of the same class by Novo Nordisk (NVO) was approved earlier this year.) The drugs, called GLP-1 agonists, work like the naturally occurring GLP-1 compound in the body to slow glucose absorption in the gut and thus allow a type-2 diabetic?s slow insulin response to catch up. Unlike the naturally occurring compound, the agonists aren't easily broken down by the body?s enzymes. The GLP-1 agonist class also attaches to an appetite receptor in the brain and decreases hunger, leading to weight loss in patients.

Yet, weight loss isn?t the only side effect of the GLP-1 agonists. Byetta sales have been bogged down by problems since reports surfaced in August 2008 that the drug could be the cause of severe pancreatitis, a disease that occasionally develops in diabetic patients anyway. Several Byetta patients that developed pancreatitis died, and cases continue to pop up. The companies are currently tied up in 39 separate liability cases concerning the drug.

While pancreatitis is the biggest drawback to these types of drugs, it isn't the only one. In 2009, the FDA notified health-care professionals that Byetta had been causing kidney problems, including renal failure. Between April 2005 and October 2008, the agency had received 62 cases of acute renal failure and 16 cases of renal insufficiency, prompting more patients to try other forms of diabetes treatments.

Novo Nordisk?s Victoza, a once-daily injection that was recently approved by the FDA, was slapped with a black-box warning -- the severest the FDA offers. However the warning wasn't about the potential kidney problems or pancreatitis that could occur, but to caution that the drug could cause thyroid tumors.

The long-acting version of Byetta is expected to be plagued by all the same problems, but it will be in a patient?s system for a full week -- a lengthy amount of time, should problems arise. The FDA is aware of the risk and it will be the agency?s job to weigh that against the potential benefit. But will patients really prefer the convenience when there are so many other options out there?