Byetta May Cause Cancer Risk

According to top a U.S. regulator at the Food and Drug Administration (“FDA”), Byetta, the diabetes drug manufactured by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., could be linked to a an increased risk of thyroid cancer.

In a memo posted on the FDA’s website, Curtis Rosenbraugh, head of the FDA’s Office of Drug Evaluation II, stated that the proposed once-weekly version of Byetta, known as Byetta LAR, appears to “give a similar signal” as cancers seen in animal testing of Novo Nordisk’s rival medication, Victoza.  This memo is the first indication that the new long-acting version of Byetta may be subject to a boxed warning, like Victoza, warning consumers and health care providers of the potential risk of thyroid tumors associated with this class of drugs. Both medications are members of a class of drugs known as GLP-1 analogs.  GLP-1 is an intestinal peptide that enhances insulin production when blood glucose levels are high. GLP-1 analogs mimic the effect of this peptide by stimulating insulin secretion from pancreatic cells.

On March 15, the FDA delayed approval of the new version of Byetta, which will be called Bydureon. Currently Byetta is approved for twice-weekly administration.  The potential cancerous side effects of the once-weekly Bydureon have not been confirmed by the FDA, or by its manufacturer. However, Byetta has been linked to dangerous renal complications, including kidney failure as well as pancreatitis.  In November 2009, the FDA warned that at least 78 cases of kidney problems have been reported since the drug went on the market, 62 of which were cases of kidney failure.  Prior to this update, in October 2007 and August 2008 the FDA issued a warning regarding reports of pancreatitis in Byetta users, two of which resulted in death.

If you or a loved one has suffered severe side effects while using Byetta, you may be entitled to compensation. Contact Chaffin Luhana’s experienced and trial-ready attorneys for a no-cost consultation at 1-888-480-1123, or via email at info@chaffinluhana.com.

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