What type of medication requires a Risk Evaluation and Mitigation Strategy (REMS)?

A Risk Evaluation and Mitigation Strategy (REMS) is a required safety program that the Food and Drug Administration (FDA) implements for certain medications that have significant risks associated with their use. The purpose of REMS is to ensure that the benefits of a drug outweigh its risks by providing a framework for managing those risks.

The type of medication that requires a REMS typically includes those with serious safety concerns, such as certain opioids, which can lead to addiction, overdose, and even death, as well as medications used to treat schizophrenia, which may present a risk of severe side effects. These drugs often require specific education, monitoring, or other strategies to mitigate risks associated with their use, such as limiting prescribing to certified healthcare providers or ensuring patients complete necessary follow-ups.

In contrast, over-the-counter medications do not usually warrant a REMS as they are presumed to be safe for use without professional supervision when used according to label instructions. Antibiotics might have adverse reactions, but they often do not require a REMS unless the risks are severe. Vitamins and dietary supplements are considered safe for the general population, and they do not require monitoring for serious safety concerns in the same manner that medications do.