What is the SILIQ REMS Program?

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

The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in subjects treated with SILIQ by:

  • Ensuring that prescribers are educated about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to counsel patients about this risk.
  • Ensuring that patients are informed about the potential risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations of suicidal thoughts and behavior, new onset or worsening depression, anxiety, or other mood changes.