Which medication is an example of one that requires a REMS program?

Isotretinoin is a medication that requires a Risk Evaluation and Mitigation Strategy (REMS) program due to its severe potential side effects, particularly its association with fetal malformations and risks of birth defects. The REMS program for isotretinoin aims to ensure that prescribers, pharmacists, and patients are aware of the risks and necessary precautions, such as the requirement for patients to use effective birth control to prevent pregnancy during treatment and for a period after discontinuation. The program also mandates that patients participate in education sessions to fully understand the risks involved.

In contrast, the other medications listed—ibuprofen, amoxicillin, and acetaminophen—do not have similar stringent safety requirements under a REMS program. While they may have warnings for potential side effects, they do not carry the same level of risk for severe adverse effects that necessitate a REMS. This distinction emphasizes the importance of the REMS for isotretinoin to manage risks effectively, particularly in the context of prescribing practices in pharmacy settings.