Evidence recently confirmed that the diabetes drug, Byetta (Exenatide), may cause an increased risk of hemorrhagic or necrotizing pancreatitis in patients using Byetta. Further, there is evidence that both the Food and Drug Administration (FDA) and the drug maker may have been aware of the problems for quite a while. If you have suffered acute pancreatitis, hemorrhagic pancreatitis, accute necrotizing pancreatitis, or pancreas cancer; and have been using Byetta (Exenatide), please seek medical advice as soon as possible. For more Byetta Hemorrhagic Pancreatitis Lawsuit or Byetta Necrotizing Pancreatitis Lawsuit information, please feel free to contact Byetta Hemorrhagic Pancreatitis Lawyer, Byetta Pancreas Cancer Lawyer, and Byetta Necrotizing Pancreatitis Lawyer Jason Coomer a Texas lawyer, or use our online submission form.
FDA Responds to Reports that Byetta (Exenatide) and Byetta (Exenatide) May Cause an Increased Risk of Hemorrhagic Pancreatitis and Necrotizing Pancreatitis
In November 2009, the FDA revised the prescribing information for Byetta to include information on reported cases of acute pancreatitis in patients using this drug. Below is information from the FDA regarding Byetta safety warnings.
Byetta Safety Update for Healthcare Professionals
As part of our ongoing efforts to keep you informed, we want to make you aware of recent safety information for Byetta, an anti-diabetic drug. On October 30, 2009, FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for Byetta. The REMS was part of an approval for a new indication of Byetta to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Previously Byetta was only approved for use in combination with other anti-diabetic drugs.
The REMS is the result of new safety information associated with the use of Byetta, including postmarketing reports of acute pancreatitis and altered kidney function. Acute pancreatitis was previously listed in the prescribing information for Byetta, but more severe forms of pancreatitis, including hemorrhagic and necrotizing pancreatitis, have been reported to FDA since the initial label update. FDA issued safety communications on these adverse event reports in 2007 (acute pancreatitis), 2008 (hemorrhagic and necrotizing pancreatitis) and 2009 (altered kidney function).
Over 7 million prescriptions for Byetta have been dispensed since it was first approved by FDA in 2005. Therefore, while these adverse events are very serious, the number of reported cases of acute pancreatitis, hemorrhagic and necrotizing pancreatitis, and altered kidney function represent a small percentage of the total number of patients who have used Byetta.
To ensure that healthcare professionals and patients fully understand the benefits and potential risks associated with the use of Byetta, the REMS contains several elements including:
A Medication Guide given to patients each time they receive a prescription for Byetta from a pharmacy. The Medication Guide explains the benefits and risks associated with using Byetta A Communication Plan requiring the manufacturer of Byetta to distribute a Dear Healthcare Professional letter discussing the potential for altered kidney function to occur in patients using Byetta Evaluating healthcare professional and patient understanding of the potential for acute pancreatitis and altered kidney function in patients using Byetta
Additionally, the sponsor, Amylin Pharmaceuticals Inc, is being required to conduct six post-marketing studies (Postmarketing Requirements [PMRs]) to help further define the mechanism, incidence, and risk factors for the development of acute pancreatitis, including hemorrhagic and necrotizing pancreatitis, associated with the use of Byetta, as well as to explore a potential signal of a serious risk of thyroid cancer and pancreatic cancer.
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- FDA NEWS RELEASE
For Immediate Release: Nov. 2, 2009
Media Inquiries: Sandy Walsh, 301-796-4669, firstname.lastname@example.org Consumer Inquiries: 888-INFO-FDA FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems
The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.
From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function 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.
Nearly 7 million prescriptions for Byetta were dispensed between April 2005 and September 2008. The 78 cases represent a small percentage of the total number of patients using the drug to control blood sugar (glucose) levels.
The most common side effects associated with Byetta include nausea, vomiting, and diarrhea. These side effects may have contributed to the development of altered kidney function. Kidney malfunction can result in a build-up of waste products in the blood, leading to serious illness or life-threatening conditions.
?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. ?Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.?
Patients who experience any of these symptoms should immediately discuss them with their health care professional.
Exenatide (marketed as Byetta) Information
[11/02/2009] FDA has 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. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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.
The revisions to the drug label allow healthcare professionals to better weigh the known benefits of Byetta with the potential risks that exist for certain patients. Changes include:
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.
Acute pancreatitis, Hemorrhagic Pancreatitis, Necrotizing Pancreatitis
Acute pancreatitis is a sudden inflammation of the pancreas that occurs over a short period of time. The pancreas is a digestive organ behind the stomach that secretes essential enzymes needed for the digestion of certain foods, including fats, carbohydrates and proteins. During an episode of acute hemorrhagic pancreatitis, several symptoms relating to digestion and abdomen may occur. In severe cases, the person may experience confusion, difficulty breathing, or respiratory failure. The person may also fall into a coma.
The severity of acute pancreatitis may range from mild abdominal discomfort to a severe, life-threatening illness. However, the majority of people with acute pancreatitis (more than 80%) recover completely after receiving the appropriate treatment. In very severe cases, acute pancreatitis can result in bleeding into the gland, serious tissue damage, infection, and cyst formation. Severe pancreatitis can also create conditions which can harm other vital organs such as the heart, lungs, and kidneys.
The warning signs of pancreatitis include: 1) Upper abdominal pain that radiates into the back. Patients may describe this as a "boring sensation" that may be aggravated by eating, especially foods high in fat. 2) Swollen and tender abdomen 3) Nausea and vomiting 4) Fever and 5) Increased heart rate.
Acute hemorrhagic pancreatitis is the sudden inflammation of the pancreas. This leads to death of pancreatic tissue and the formation of lesions, causing extensive bleeding.
Necrotizing pancreatitis is a serious health condition where a person's pancreas is inflamed and bleeding. In Necrotizing Pancreatitis patients, there is inflammation and tissue death, with the pancreas destroying itself. Whereas in Hemorrhagic Pancreatitis patients, the pancreas is bleeding. Both are serious conditions and should be treated immediately.
Byetta Hemorrhagic Pancreatitis Lawyer, Byetta Necrotizing Pancreatitis Lawyer, Byetta Death Lawyer, Byetta Hemorrhagic Pancreatitis Lawyers and Byetta Necrotizing Pancreatitis Lawyers
Texas Dangerous Drug Attorney, Jason Coomer, commonly works with other lawyers throughout the nation including Chicago Byetta Pancreatitis Lawyers, Boston Byetta Pancreatis Lawyers, New York Byetta Acute Pancreatitis Attorneys, California Diabetes Drug Pancreatitis Attorneys, Houston Byetta Lawyers, Oklahoma Diabetes Drug Pharmaceutical Lawyers, Dallas Byetta Death Lawyers, and other Texas Dangerous Drug Claim Lawyers. By sharing information and working together, his law firm and other firms throughout the nation are able to provide better representation for their clients.
If you have suffered acute pancreatitis, hemorrhagic pancreatitis, accute necrotizing pancreatitis, or pancreas cancer; and have been using Byetta (Exenatide), please seek medical advice as soon as possible. For more Byetta Hemorrhagic Pancreatitis Lawsuit or Byetta Necrotizing Pancreatitis Lawsuit information, please feel free to contact Byetta Hemorrhagic Pancreatitis Lawyer, Byetta Pancreas Cancer Lawyer, and Byetta Necrotizing Pancreatitis Lawyer Jason Coomer a Texas lawyer, or use our online submission form.