The Injectable Diabetes Drug Byetta May Cause Thyroid Cancer: Persons Taking Byetta Should Be Aware of Thyroid Cancer Danger and Consult Their Physician Regarding Potential Thyroid Cancer Risks by Texas Byetta Thyroid Cancer Lawyer and Byetta Cancer Death Lawyer Jason S. Coomer
Recent studies indicate that the diabetes drug, Byetta, may cause an increased risk of thyroid cancer. The injectable diabetes drug, Byetta (Exenatide), was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. Byetta was approved in the U.S. in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction. Nearly 7 million prescriptions for Byetta were dispensed between April 2005 and September 2008.
If you or a loved one has taken Byetta and has been diagnosed with thyroid cancer or pancreatic cancer, please feel free to contact Byetta Thyroid Cancer Lawyer, Byetta Cancer Lawyer, and Byetta Pancreatic Cancer Lawyer Jason Coomer a Texas lawyer, or use our online submission form.
FDA Advisory: 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.
The Diabetes Drug Market is Over $40 Billion Each Year and Growing Rapidly Byetta had Annual Sale of Over $500 Million in 2010
More than 300 million people worldwide suffer from diabetes, including nearly 26 million Americans. The global market for products in the management of diabetes currently stands at $41 billion and is on pace to grow to over $114 billion by 2018.
Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. Byetta exhibits many of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. Byetta was approved in the U.S. in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction. Nearly 7 million prescriptions for Byetta were dispensed between April 2005 and September 2008. In 2010 Byetta sales were over $500 million.
Byetta Thyroid Cancer Lawsuits and Byetta Cancer Lawsuits
Byetta Thyroid Cancer Lawsuits and Byetta Pancreatic Cancer Lawsuits are in the process of being reviewed and filed as recent scientific evidence indicates that the injectable diabetes drug, Byetta (Exenatide), may cause an increased risk of Thyroid Cancer and Pancreatic Cancer. Early detection of both type of cancer is essential to preventing the cancer spreading and survivingc cancer.
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.
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.
Byetta Pancreatic Cancer Death Lawyers, Byetta Pancreas Cancer Lawyers and Byetta Pancreatitis Lawyers
Texas Diabetes Drug Attorney, Jason Coomer, commonly works with other lawyers throughout the nation including National Pancreatic Cancer Lawyers, International Byetta Pancreatic Cancer Lawyers, Chicago Byetta Pancreatic Cancer Lawyers, Boston Byetta Pancreas Cancer Lawyers, New York Byetta Pancreatitis Attorneys, California Diabetes Drug Pancreatic Cancer Attorneys, Houston Byetta Cancer Lawyers, Florida Diabetes Drug Pharmaceutical Lawyers, Dallas Byetta Cancer Death Lawyers, and other Texas Dangerous Drug Claim Lawyers. By sharing information and working together, his law firm and other firms throughout the nation and the world are able to provide better representation for there clients.
- FDA NEWS RELEASE: For Immediate Release: Nov. 2, 2009
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 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.
Byetta Pancreatic Cancer Lawyers, Byetta Pancreatitis Lawyers, Byetta Cancer Death Lawyer, Byetta Thyroid Cancer Lawyers and Byetta Pancreas Cancer Lawyers
Texas Pancreatic Cancer Attorney, Jason Coomer, commonly works with other lawyers throughout the nation including Chicago Byetta Pancreatitis Lawyers, Boston Byetta Thyroid Cancer Lawyers, New York Byetta Cancer Attorneys, California Diabetes Drug Pancreatitis Attorneys, and Houston Byetta Cancer 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 lost a loved one from Pancreatic Cancer or have suffered acute pancreatitis, hemorrhagic pancreatitis, accute necrotizing pancreatitis, or pancreas cancer; and have been using Byetta (Exenatide), please report the adverse action to the prescribing medical doctor as soon as possible. For more Byetta Pancreatic Cancer Lawsuit, Byetta Cancer Death Lawsuit, or Byetta Pancreas Cancer Lawsuit information, please feel free to contact Byetta Pancreatic Cancer Lawyer, Byetta Cancer Lawyer, and Byetta Pancreas Cancer Death Lawyer Jason Coomer a Texas lawyer, or use our online submission form.
Feel Free to Contact Us with any Questions
Associations