Definition: A REMS (Risk Evaluation and Mitigation Strategy) is a drug safety program FDA can require for certain medicines with serious safety concerns, to help make sure the benefits outweigh the risks. FDA says only a few medicines need one. It targets one specific serious risk rather than every side effect.
FDA says every medicine has labeling that tells providers about its risks, and that most adverse events are covered there, in the prescribing information. A REMS adds actions on top: it focuses on preventing, monitoring or managing one serious risk by informing, educating or reinforcing steps that make it rarer or less severe. Some programs limit who can prescribe or dispense the drug.
| Product | Risk | What the program requires |
|---|---|---|
| Aveed (testosterone undecanoate) | Oil microembolism in the lungs (POME) and anaphylaxis during or after an injection | Certified prescribers and health care settings; 30 minutes of observation after each shot |
| Qsymia (phentermine and topiramate) | Birth defects, including cleft lip or palate | Dispensed only by certified pharmacies; pregnancy test before starting and monthly |
FDA's own example is Zyprexa Relprevv, a long-acting injection that may only be given in certified facilities that can watch patients for at least 3 hours.
A REMS can shape where and when you get a dose. With Aveed, for example, every shot happens in a certified clinic with a wait afterwards. Logging the date and site of each clinic dose keeps your history complete even when you do not inject it yourself.
Read more on Dose Track: Aveed side effects · Qsymia side effects · Aveed vs testosterone cypionate