Byetta Side Effects a Fact of Life

San Diego, CARarely, if ever, will you hear pharmaceutical companies claim that drugs are safe. The preferred position is the 'positive benefit-risk profile' for patients suffering from some malady—typically the condition for which the drug was approved. In the case of Byetta acute pancreatitis has claimed lives, while others have been made to deal with Byetta side effects. The Byetta drug was approved to treat type 2 diabetes. But was acute pancreatitis foreseen?

That's the million-dollar question, or rather the billion-dollar question—as some drugs have been known to make billions for their respective manufacturers. It also appears to be a given that all drugs effectively treat the condition for which they were conceived, but can't appear to do so without screwing something else up. Hence, the seemingly constant presence of the side effect. Best-case scenario: the side effect is an inconvenience you'll learn to live with as a trade-off for the benefit.

At worst, the side effect could kill you, or at the very least make the rest of your life miserable.

Byetta, an injectable drug, was approved in 2005 to treat type 2 diabetes. Since then there have been reports of pancreatitis, including acute pancreatitis—an extremely serious condition. So far six patients have died, while others have been hospitalized.

In mid-August, the US Food and Drug Administration (FDA) released an alert with regard to the possibility for pancreatitis, a risk that has been known and already included in prescribing information for Byetta since 2006. This most recent update serves to verify the concern, coupled with the release of a recent study, which was shown to reveal that patients with Type 2 diabetes carried nearly three times the risk of developing pancreatitis than those without diabetes.

Following the FDA alert on August 18th, Byetta manufacturers Amylin and Eli Lilly have been doing what some have described as damage control after the stock price at Amylin reportedly fell 30 percent following the FDA alert, together with the latest news with regard to renewed concerns over Byetta.

The manufacturers noted, in a late-summer conference call, that while a definite causal relationship between Byetta and pancreatitis has yet to be established, or proven beyond a reasonable doubt, the manufacturers have been pursuing a comprehensive drug safety program that includes extensive internal, and external review of individual cases, together with clinical and epidemiological studies.

"At Amylin and Lilly, patient safety is our foremost concern. We are committed to continuing to work closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products," said Orville G. Kolterman, Senior Vice President, Research and Development at Amylin. "It is important to understand that pancreatitis, an inflammatory condition of the pancreas, is a rare event. Further, the characteristics and complications of the pancreatitis cases in patients on Byetta are consistent with pancreatitis in the general population. We believe Byetta continues to have a positive benefit-risk profile for patients with type 2 diabetes."

There it is again: 'positive risk-benefit profile.'

While patient safety is articulated, nowhere do they state that the drug itself, is safe.

For that matter, do any of them?