|
Were you prescribed Byetta for type 2 diabetes mellitus and now find yourself diagnosed with diminished or damaged kidney function? "Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research. -- from the Nov. 2 FDA News Release. “From April 2005 through October 2008, the 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 the Food and Drug Administration MedWatch Safety Alert of November 2, 2009 Common Side Effects of Byetta® The following side effects have been reported, and are the most often observed:
• Diarrhea
• Nausea
• Vomiting
These were also the most common side effects linked to with Byetta® in clinical trials. It is believed that these side effects might be implicated in the later development of altered kidney function in the reported cases. Severe Side Effects Reported with Byetta® Use The following side effects have also been potentially attributed to the use of Byetta®:
• Death
• diminished or damaged kidney function
• Renal Failure
• Pancreatitis
If you or a loved one have been prescribed Byetta® and now have been diagnosed with diminished or damaged kidney function, renal failure, or pancreatitis, please contact us immediately for a free consultation. Always consult with your physician before you stop taking any medications, including Byetta®. What is Byetta®? Byetta® (exenatide) is manufactured by Amylin Pharmaceuticals Inc., based in San Diego. A diabetes medicine that is administered through injection, Byetta helps control blood sugar levels by helping the pancreas produce insulin more efficiently. Most commonly used to treat type 2 diabetes, Byetta® is sometimes used in combination with other diabetes medicines, and is approved as an adjunct to diet and exercise. Byetta was prescribed nearly 7 million times between April 2005 and September 2008, the time period of the case studies. Type 2 Diabetes and Byetta® 90% of all diabetics have Type 2 diabetes, which develops later in life than Type 1 and is often associated with excess weight. Worldwide, there are an estimated 200 million people with diabetes. In its early stages, Type 2 diabetes can be controlled through diet and exercise. Byetta® Timeline: August 2008 – November 2009 August 2008: the FDA issues a MedWatch alert about six new cases of hemorrhagic and necrotizing pancreatitis that had been reported to FDA. Pancreatitis is the medical term for inflammation or infection of the pancreas. March 2009: the drug regulation organization in the United Kingdom (UK) published an article titled, "Exenatide (Byetta): risk of severe pancreatitis and renal failure" in the March 2009 Drug Safety Update Newsletter. The article discussed two serious side effects potentially associated with Byetta®, pancreatitis and renal (kidney)impairment. Then on November 2, 2009 the FDA issued a MedWatch Safety Alert, after reports of altered kidney function in patients using Byetta® increased. Concerned, the FDA approved revisions to the drug label of Byetta® to warn of the potential risks. Labeling changes include (directly from FDA MedWatch): • Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease. • Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min). • Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product. • Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.
If You Have Been Injured by Byetta® Have you or a loved one been injured after taking Byetta®? For a free evaluation of your potential claim, call 1-888-446-8087, or fill out an intake form on this website by clicking on "Can We Help You?" on the upper right hand corner of the home page.
|
