The consumer group, Public Citizen, is recommending that patients wait until at least the year 2012 before taking the prescription diabetes drug, Byetta.
Public Citizen issued the warning in the November 2009 issue of its Worst Pills, Best Pills report.
As is true with many drugs, we don’t really know the side effects until a drug has been used on a population for at least five to seven years.
In the case of Byetta (exenatide), the Food and Drug Administration (FDA) has recently announced that additional information will be added to the drug’s label warning of a risk of kidney failure among users, including reports of acute renal failure. Reportedly 80 adverse events have been linked to Byetta concerning kidney function.
In 2007 and again in 2008, the FDA issued safety alerts about Byetta and pancreas problems, including severe hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal.
Public Citizen launched its own independent analysis of a longer reporting period of 47 months concerning Byetta, and found a total of 181 reports of acute pancreatitis between April 2005 and March 2009, including 142 serious cases that required hospitalization.
“The studies that looked at exanatide were too short and too small to answer any questions about whether or not the drug improves the overall health or quality of life for patients with Type-2 diabetes,” states Public Citizen. “Exenatide has not been shown to reduce any meaningful endpoints, including, but not limited to, the risk of death, neuropathy, vision loss, heart disease or any of the other major complications of Type-2 diabetes.”
Patients should know that symptoms include nausea, vomiting and severe pain in the upper abdomen and back and an increase in respiratory and heart rates. The FDA says a patient Medication Guide should be developed to make patients aware of the risks and the physical symptoms of problems with Byetta.
Drug maker and distributor, Amylin and Eli Lilly, issued a statement saying they agreed with the label changes and that there is no evidence in studies of any evidence linking Byetta and kidney damage.
Byetta was approved by the FDA in April 2005.
Waiting seven years gives patients time to see whether the FDA will add any “black box” or the strongest label warning under federal law to a new drug, while generally it takes about two years for the FDA to decide whether a drug should even stay on the market.