Diabetes drug exenatide (Byetta) could cause cancer: US FDA

Byetta (exenatide), the anti-diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co, can have potential cancer risks to pateints using the drug, experts from US FDA warns.

Byetta (exenatide) belongs to a new class of diabetes medicines that imitate a hormone called GLP-1 to stimulate the pancreas to produce more insulin after meals.

GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.

Byetta (exenatide) is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program.

Byetta (exenatide) is not recommended to be taken with insulin.It is not for people with type 1 diabetes or people with diabetic ketoacidosis.

Byetta (exenatide) provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss.

Byetta was approved in April 2005 and has been used by more than one million patients since its introduction, claim its marketers.

Recently, US FDA has delayed approval for a proposed once-weekly version of Byetta (exenatide) and asked for more information on manufacturing, labeling and a risk-management plan.

Clinical research data on intravenous exenatide and its extended-release form “seem to give a similar signal” as cancers seen in rodent studies of Novo Nordisk A/S’s competing Victoza, chemically known as liraglutide, stated head of the Food and Drug Administration’s Office .

Exenatide may be giving a “false sense of security” to doctors and patients about potential cancer risks, according to him.

In October 2009 US FDA approved an expanded indication for Byetta (exenatide) injection enabling it for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes.

Previously, it was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control.

In 2009, US FDA also approved revisions to the drug label for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.

From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta.

Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems.

From April 2005 through September 2008, more than 6.6 million prescriptions1 for Byetta were dispensed. Therefore, the 78 reported cases of altered renal function represent a small percentage of the total number of patients who have used the drug.

Some of the 78 patients reported nausea, vomiting, and diarrhea–the most common side effects associated with Byetta in clinical trials. These side effects may have contributed to the development of altered kidney function in the reported cases.

Diabetes affects man estimated 285 million adults worldwide.

Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the U.S. and costs approximately $174 billion per year in direct and indirect medical expenses.

According to the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.

In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.5 Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.