Byetta Safety Update for Healthcare Professionals

As part of our ongoing efforts to keep you informed, we want to make you aware of recent safety information for Byetta, an anti-diabetic drug. On October 30, 2009, FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for Byetta. The REMS was part of an approval for a new indication of Byetta to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Previously Byetta was only approved for use in combination with other anti-diabetic drugs.

The REMS is the result of new safety information associated with the use of Byetta, including postmarketing reports of acute pancreatitis and altered kidney function. Acute pancreatitis was previously listed in the prescribing information for Byetta, but more severe forms of pancreatitis, including hemorrhagic and necrotizing pancreatitis, have been reported to FDA since the initial label update. FDA issued safety communications on these adverse event reports in 2007 (acute pancreatitis), 2008 (hemorrhagic and necrotizing pancreatitis) and 2009 (altered kidney function).

Over 7 million prescriptions for Byetta have been dispensed since it was first approved by FDA in 2005. Therefore, while these adverse events are very serious, the number of reported cases of acute pancreatitis, hemorrhagic and necrotizing pancreatitis, and altered kidney function represent a small percentage of the total number of patients who have used Byetta.

To ensure that healthcare professionals and patients fully understand the benefits and potential risks associated with the use of Byetta, the REMS contains several elements including:

• A Medication Guide given to patients each time they receive a prescription for Byetta from a pharmacy. The Medication Guide explains the benefits and risks associated with using Byetta
• A Communication Plan
  • requiring the manufacturer of Byetta to distribute a Dear Healthcare Professional letter discussing the potential for altered kidney function to occur in patients using Byetta
• Evaluating healthcare professional and patient understanding of the potential for acute pancreatitis and altered kidney function in patients using Byetta

Additionally, the sponsor, Amylin Pharmaceuticals Inc, is being required to conduct six post-marketing studies (Postmarketing Requirements [PMRs]) to help further define the mechanism, incidence, and risk factors for the development of acute pancreatitis, including hemorrhagic and necrotizing pancreatitis, associated with the use of Byetta, as well as to explore a potential signal of a serious risk of thyroid cancer and pancreatic cancer.