Information for Byetta® Users Who May Have Suffered Injury: Byetta® has been potentially linked to Kidney-Related Side Effects and Acute Renal Failure“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 Side Effects of Byetta®In the 78 cases the FDA gathered from April 2005 through October 2008, the following was reported: These were the most common side effects linked to with Byetta® in clinical trials, and these side effects may have contributed to the development of altered kidney function in the reported cases. The following side effects have also been potentially attributed to the use of Byetta®: - Death
- Kidney Dysfunction
- Renal Failure
- Pancreatitis
If you or a loved one have been prescribed Byetta® and now have been diagnosed with renal failure, altered kidney function, or pancreatitis, please contact us immediately for a free consultation. Always consult with your physician before you stop taking any medications, including Byetta®. About Byetta®Byetta® (exenatide) is manufactured by San Diego-based Amylin Pharmaceuticals Inc. 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. About Type 2 Diabetes 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® and its Possible Link to Altered Kidney Function and Renal Failure: Timeline
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. 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 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 (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.
The Mulligan Law Firm is currently investigating injury claims involving Byetta®. If you or a loved one has been diagnosed with altered kidney function, renal failure, or pancreatitis after taking Byetta®, it is important that you consult with a legal professional immediately. The Mulligan Firm’s experienced lawyers are standing by to help you. Do Not WaitYou may be entitled to compensation for your injuries. We take all cases on a contingency-fee basis, which means you do not pay for our services unless you receive an award or compensation. Do not delay, as your rights and compensation may be lost forever if you wait.
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