Byetta FDA Warnings
The U.S. Food and Drug Administration (FDA) has issued several warnings about side effects from Byetta, a diabetes drug manufactured by Bristol-Myers Squibb.
In particular, the FDA issued a “Drug Safety Communication” in March 2013 that addressed a possible link between a class of drugs called “incretin mimetics,” which includes Byetta, and the “risk of pancreatitis and pre-cancerous findings of the pancreas.”
If you or a loved one has suffered acute pancreatitis or other adverse side effects after taking Byetta to treat diabetes, a lawyer from The Driscoll Firm, LLC, wants to help you. Contact us today and set up a free consultation by calling us toll-free or completing our online form.
Pancreas Problems Associated with Byetta
Exenatide, a type of incretin mimetic, is marketed as Byetta and Bydureon. These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. When used with diet and exercise, incretin mimetics can lower blood sugar in adults with Type 2 diabetes.
The FDA’s most recent warning about incretin mimetic drugs, including Byetta, is based on a study published by the Johns Hopkins School of Medicine in February 2013.
The Johns Hopkins researchers’ findings “suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called ‘pancreatic duct metaplasia’ in patients with Type 2 diabetes” who were treated with incretin mimetics, the FDA said. The study examined insurance records and found that the use of exenatide or sitagliptin (another incretin mimetic) could double the risk of developing acute pancreatitis.
The FDA says it is evaluating data from the Johns Hopkins study and other sources and has not concluded that Byetta or other incretin mimetics may cause or contribute to the development of pancreatic cancer.
Byetta and Kidney Failure
In November 2009, the FDA reported that it had received 78 reports 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.
Health Magazine reported in 2011 that 91 percent of the patients who suffered kidney failure after taking Byetta were hospitalized, 18 required dialysis, two had kidney transplants, and four died. Eighty percent stopped taking Byetta, and half of those patients had improved kidney function afterward, according to the magazine article.
The FDA responded to reports of kidney failure by ordering changes to the drug’s warning label that reflect these reports. The FDA also recommended that healthcare professionals monitor patients carefully for the development of kidney dysfunction and evaluate the continued need for Byetta if kidney dysfunction is suspected among patients using the product.
Kidney failure is a side effect of pancreatitis, according to the Mayo Clinic.
Are You Suffering Pancreas Problems After Taking Byetta? Contact Our Lawyers Today
The Driscoll Firm, LLC, has helped victims of defective drugs across the U.S. to obtain money for medical expenses, lost income, and pain and suffering. We seek the maximum compensation for our clients in every case. If you believe that you or loved one is suffering from Byetta-related pancreas problems, we want to help you, too. Contact us for a free initial consultation about your case today. Call our toll-free number or fill out our online form without delay.
For more information:
- FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes, U.S. Food and Drug Administration
- Safety Alert – Byetta (exenatide), U.S. Food and Drug Administration
- Byetta (exenatide) – Renal Failure, U.S. Food and Drug Administration
- Some Diabetes Drugs Linked To Pancreatitis Risk, Medical News Today
- Diabetes drug Byetta tied to kidney problems, says FDA, Health Magazine (via CNN)
- Pancreatitis, the Mayo Clinic