Pancreatitis from Byetta: FDA Requires Additional Studies
According to a letter from the FDA expanding the approved uses of the diabetes drug Byetta, additional post-marketing studies are needed to further assess the risk of pancreatitis from Byetta. The lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a Byetta lawsuit as a result of the drug makers’ previous failure to adequately research their medication and warn about the serious and potentially life-threatening side effects.
>>PRIOR POST: Byetta Pancreatitis Lawsuit Evaluations
On October 30, 2009, Eli Lilly & Co. and Amylin Pharmaceuticals announced that the FDA approved their type-2 diabetes treatment as a standalone therapy. However, they did not disclose that the FDA was requiring additional studies into the risk of Byetta pancreatitis side effects.
That information surfaced last week, when an analyst with Citigroup, Yaron Werber, obtained a copy of the FDA’s approval letter and reported to investors that the FDA is requiring studies to clarify the risk after receiving reports of pancreatitis from Byetta, including several deaths.
According to the FDA letter:
Since Byetta (exenatide) was approved on April 25, 2005, we have become aware of postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, and post marketing reports of acute renal failure, sometimes leading to death or transplantation, in patients taking Byetta (exenatide). We have also become aware of postmarketing reports of thyroid neoplasms associated with the use of Byetta (exenatide) and of a signal of thyroid neoplasms observed pre-clinically with other GLP-1 analogues. We consider this information to be ‘new safety information’ as defined in section 505-1(b)(3) of the FDCA.
After consideration of this new safety information, we have deterined that postmarketing requirements are needed to assess the risk of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, and the risk of thyroid neoplasms, and a REMS (Risk Evaluation and Mitigation Strategy) is necessary for Byetta (exenatide) to ensure that the benefits of the drug outweigh the risks of acute pancreatitis and acute renal failure.
BYETTA LAWYERS
The attorneys at Saiontz & Kirk, P.A. are continuing to investigate potential lawsuits for individuals who have been diagnosed with acute pancreatitis or more severe hemorrhagic pancreatitis or necrotizing pancreatitis. Potential Byetta kidney failure lawsuits are also being reviewed for individuals diagnosed with renal insufficiency after using the drug.
To review a potential lawsuit with our Byetta lawyers for yourself a friend or family member, request a free consultation and claim evaluation.
