Byetta: Potential New Warnings, Same Old Drug…

Washington, DCLook for a stronger warning label for Byetta, now that the US Food and Drug Administration (FDA) has signaled that it wants to up the ante in an effort to protect Americans from Byetta side effects impacting the pancreas.

And if there is any good news coming from the FDA in recent months, it is their newfound capacity to override the objections of manufacturers, if the agency feels a stronger warning is appropriate. Until recently, the agency and the drug manufacturer needed to agree on updates to a warning label—and the agency still prefers to negotiate with manufacturers in good faith as the preferred path to a stronger warning.

However, if the manufacturer balks at a warning the FDA feels strongly about, the FDA comes out on top. At least, it now has the legal, and regulatory clout to do so.

In recent months there have been two deaths of patients taking Byetta for Type 2 diabetes, and six cases of pancreatitis reported in association with Byetta. The concern has to do with the fact that these six cases in question have occurred since a label update was undertaken last October.

The latter occurred after the FDA reviewed no fewer than 30 post-marketing reports of acute pancreatitis in patients using Byetta in an effort to control, and regulate their diabetes.

Byetta is approved for, and is typically used by Type 2 diabetes patients whose blood sugar levels have failed to come under control. Byetta is also approved as an addendum therapy for patients using metformin, sulfonylurea or thiazolidinedione.

"Amylin and Lilly are committed to patient safety and to working with FDA to ensure that our Byetta product label continues to provide physicians and patients with information about the risk of pancreatitis," the manufacturers said in a statement. "In accordance with our strict internal processes, we continuously monitor and notify regulatory authorities of adverse events reported during the use of any of our drugs."

Eli Lilly, and Amylin also indicated to the Washington Drug Letter that they are aware of the six cases of pancreatitis, but added such reports are considered rare. What's more, according to the manufacturers, Type 2 diabetes patients already carry a greater risk for developing pancreatitis, as compared with the greater population.

This debate will most assuredly become a part of the labeling negotiation between the manufacturers and the FDA—and it will be interesting to see if the two sides agree, or the negotiations become strained. Of course, the manufacturers will be painfully aware that the more stringent the warning, the greater the potential loss of market share in the multi-billion dollar diabetes market. That could hurt Amylin, which derives about 80 percent of its annual revenue from Byetta sales.

Byetta was approved by the FDA in 2005, and achieves sales of $636 million.

While critics of Byetta, and any drug with potentially dangerous side effects would welcome the addition of a more stringent warning, it should be noted that a beefed-up warning is just that—a warning: mere text on a page, alerting the physician or the patient to the potentially harmful side effects of a product.

But a better warning does not make the drug safer. There is no re-formulation, or re-design of the drug itself. It's the same old stuff, but with slightly better information.

Some, including attorneys conducting Byetta lawsuits, say such information should have been there from the very beginning…