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Risk Evaluation and Mitigation Strategy

A Risk Evaluation and Mitigation Strategy (REMS) is required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug, and to help ensure that the benefits of the drug outweigh its risks.

To ensure that BYDUREON is prescribed and taken safely, Amylin has developed materials to inform patients and healthcare providers about the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma associated with the use of BYDUREON. To learn more about these serious risks, read the  Medication Guide provided in the links below, including the Important Safety Information.

The goals of the BYDUREON REMS are:

  • To inform providers about the risk of acute pancreatitis (including necrotizing and hemorrhagic pancreatitis) and the potential risk of medullary thyroid carcinoma associated with BYDUREON.
  • To educate patients about the serious risks associated with BYDUREON.

To learn more, download these important documents: