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Byetta Side Effects Do Not Stop Additional Use Approval

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Dallas, TXWhen patients deal with serious conditions such as diabetes, drugs like Byetta can be lifesavers. The problem, however, is when patients have to deal with reported Byetta side effects and other health problems allegedly brought about by their use of the drug. Despite some reported concerns about Byetta side effects, the diabetes drug has been approved for additional uses beyond the original approvals.

Byetta is an injectable drug used to treat type II diabetes. The drug, known generically as exenatide, was approved by the US Food and Drug Administration in 2005. It was marketed by Amylin Pharmaceuticals, Inc and Eli Lilly & Company, although the two companies have announced they are parting ways, with Amylin taking over Byetta.

In 2009, the FDA sent a letter to Amylin Pharmaceuticals, demanding that further studies be conducted on the risk of side effects linked to Byetta.

"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 postmarketing reports of acute renal failure, sometimes leading to death or transplantation, in patients taking Byetta (exenatide)," the FDA noted in its letter. The agency further cited reports of thyroid neoplasms associated with Byetta use.

The agency then requested that Amylin conduct post-marketing research to determine the risk of acute pancreatitis and thyroid neoplasms. Furthermore, the agency requested a Risk Evaluation Management Strategy (REMS) for the medication, to ensure that the benefits of Byetta continue to outweigh the risks.

Back in 2007, the FDA issued an alert that Byetta was potentially linked to cases of acute pancreatitis. According to a 2008 update from the FDA, between the time the October 2007 alert was issued and the time the August 18, 2008 alert was issued, the FDA "received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta."

Despite those concerns, Byetta was approved for additional use beyond the original indication. In the fall of 2011, the FDA approved Byetta to be used with or without metformin and/or Actos to treat type II diabetes. In March 2012, the European Medicines Agency also approved Byetta for the additional use.


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