The FDA has warned Amylin Pharmaceuticals that they have made false and misleading statements about the diabetes drug Byetta.
The FDA letter was sent to Amylin Pharmaceuticals, alerting the company that federal regulators were aware of statements made by representatives that provided misleading or false information about the benefits of their product.
Download the FDA Warning Letter here.
In a letter to Amylin Pharmaceuticals regarding Byetta (exenatide) , the agency said that representatives speaking at the Endocrine Society’s Annual Meeting (ENDO) in June promoted the drug for off-label uses, saying that it could be used as a stand-alone diabetes treatment, when Byetta was only approved at the time for use with other diabetes medications. Since that time, Byetta has been approved for solo use. The letter also says that representatives exaggerated the potential weight loss benefits of Byetta, and overstated its efficacy.
Byetta is a type 2 diabetes drug that is used to control blood sugar levels. It is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels.
In November, the FDA issued a new warning indicating that they have received at least 78 post-marketing reports that link Byetta side effects to kidney problems, including 62 cases where the users experienced kidney failure.
And in October 2007 and August 2008, the FDA issued safety alerts about reports of Byetta pancreatitis problems, including severe cases of hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal.
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 214-390-3189 or Contact Me Online.
The Dr. Shezad Malik Law is currently evaluating and accepting Byetta Pancreatitis cases.
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