Renewed Concerns About Byetta After Patient Deaths

Washington, DCA drug previously linked with acute pancreatitis is once again under scrutiny by the US Food and Drug Administration (FDA) after reports continue to come in with regard to Byetta, the injectable medication from Amylin and Eli Lilly used as a treatment for Type 2 Diabetes.

The FDA said Monday that it is giving consideration to an update of Byetta's labelling, and that doctors should consider prescribing other medications to patients with a history of pancreatic difficulty.

This isn't good news for manufacturers Eli Lilly and Amylin, given the fact that the diabetes medicinal industry is a $24 billion global juggernaut. According to a report by the Associated Press, Byetta represented a whopping 80 percent of San Diego-based Amylin's revenue last year. Sales of $636 million account for about three percent of Eli Lilly's revenue. Needless to say, it appears as if Eli Lilly would not suffer much from a drop in Byetta sales. However, Amylin could be hurt.

Not surprisingly, the manufacturers were quick to defend their product. Amylin and Eli Lilly released a statement indicating that patients taking Byetta have shown "very rare case reports of pancreatitis with complications or with a fatal outcome." The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients.

That's not good enough for federal regulators. The FDA is said to be working on a stronger warning label for Byetta after reports of deaths in association with the use of Byetta, despite updated warnings and alerts last fall.

It was in October last year that the federal drug regulator issued an alert after some 30 reports of Byetta patients developing problems with their pancreas, the organ responsible for producing several important biological fluids including insulin, the sugar-regulating hormone that most diabetics lack.

Eli Lilly and Amylin agreed to add the additional warnings to product labelling last fall, but the FDA has become concerned after six new reports with regard to pancreatitis have come in. Four patients are recovering, but two have died.

Byetta was approved by the FDA and launched in June of 2005. Since that time nearly three-quarters of a million diabetics have used the medication, and the makers of Byetta feel sufficiently bullish about the drug's future, they are in the throes of developing a new version that reduces the required injection frequency to one week, an improvement over the twice-daily injections currently required.

However, it has been reported that investors are taking a wait-and-see approach. While Wall Street has bestowed upon Amylin an 'outperform' rating, one analyst indicated that such a rating could change based on new information that emerges. In fact, analyst Thomas Russo of Robert Baird & Co. indicated to the Associated Press that this most recent concern with regard to Byetta could influence the FDA when it comes time to deal with the new version of the drug.

Thus, investors have been cautioned. Meantime the market showed its displeasure with Monday's news by fostering a drop of 13 percent in Amylin Pharmaceuticals stock, while Eli Lilly dropped 73 cents to close at $48.05 on the news.

In the meantime federal health regulators have cautioned patients to stop taking Byetta the instant they appear to develop signs of acute pancreatitis. The latter is a serious swelling of the pancreas that can induce vomiting, nausea and abdominal pain. The FDA went further, to suggest that it's pretty tough to distinguish between acute pancreatitis and less-severe forms of the condition, so patients were cautioned to take no chances.

Patients who have developed, and have been disabled in some way by acute pancreatitis may wish to consider contacting a Byetta attorney to discuss your options. After all, this link to the pancreas was identified nearly a year ago, and this latest focus on the Type 2 diabetes drug may suggest that earlier warning signs were not sufficiently heeded by those charged with the responsibility to heed them, to your detriment…