Byetta Nausea: Common and Serious Side Effect?

New York, NYSanofi-Aventis has likely pleased their investors by reporting recent positive results with its diabetes drug Lixisenatide, one of the new GLP-1 class of diabetes drugs, which also includes Byetta, marketed by Eli Lilly & Co. and Amylin Pharmaceuticals Inc. But the report was also based on a study of only 361 patients over the course of three months—also similar to Byetta.

In 2005, a Byetta lawsuit was filed by a Virginia man who was hospitalized after being injected with the diabetes medicine. He alleged that Eli Lilly and Amylin Pharmaceuticals rushed the diabetes drug to market and failed to adequately test it prior to market release.

In this latest study, Sanofi-Aventis reported that side effects with Lixisenatide included nausea, which is also the most common Byetta side effect. On the surface, a diabetic would probably say the benefit of Byetta outweighs the risk, if a minor problem such as nausea is the only concern. But for some Byetta patients, the nausea and vomiting may be a precursor to more serious side effects.

Between April 2005 and October 2008, Byetta side effects reported to the FDA included nausea, vomiting, and diarrhea. (During this same time period, 6.6 million prescriptions for the diabetes treatment Byetta were written.) These were also the most common side effects experienced with Byetta during clinical trials. At that time, the FDA said, "It is unknown at present if the side effects may have contributed to the development of altered kidney function and acute renal failure."

By November 2009 the agency had second thoughts. It said Byetta can heighten the risk of kidney problems, including kidney failure, in people suffering from type 2 diabetes.

So, an indicator of kidney damage could include nausea or vomiting. However, vomiting can also lead to kidney failure.

"It is thought that the main reason nausea occurs is the effects of Byetta on the stomach," explained Dr. Richard Hellman, a clinical professor at the University of Missouri-Kansas City School of Medicine. He also said that Byetta can cause side effects that include diarrhea, nausea and vomiting, which can ultimately lead to alterations in kidney function. "If someone starts vomiting, they can lower the volume of fluid in their body. If it gets to dangerously low levels, their kidneys could be damaged and kidney failure could take place."

A number of Byetta patients have complained to LawyersandSettlements of extremely severe vomiting.