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As the medical and legal communities begin to react to the recent study surrounding Byetta and its link to pancreatic cancer, attention turns to the FDA and its safety practices surrounding the initial approval of the drug. With recent evidence linking use of the drug to pancreatic cancer, it is important to revisit the FDA’s drug evaluation techniques to understand how the drug first was approved for distribution to patients, and any warnings the FDA may have provided to physicians and patients alike regarding its use.

The FDA initially reviewed the drug in 2005, and although they noted the potential risk of pancreatitis and pancreatic cancer in test subjects, the incidence of such complications were so seemingly low it was approved for use. After the drug was initially flagged by the FDA in 2007, the FDA followed up their flag on the drug with a Risk Evaluation and Mitigation Strategy (REMS). This was part of an effort to push Byetta as an adjunct to diet and exercise, and improve glycemic control in adults with type II diabetes.

Through this REMS the FDA hoped to provide professionals and patients with a complete understanding of the drug’s use and potential side effects. Contained within the REMS were medication guides and disclosure letters regarding the potential complications with the medicine. The FDA continued to warn physicians and patients regarding use of the drug but never formally withdrew their approval of use.

As Byetta and similar diabetes drugs receive heavy media attention, it is important that you consider your rights if you have been harmed as a result of the use of such medication. If you or a loved one have suffered as a result of Byetta it is important to seek legal consultation immediately.

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