Which of the following correctly describes REMS programs mentioned?

• A. Pseudoephedrine has REMS
• B. Isotretinoin has REMS
• C. Thalidomide has REMS
• D. Thalidomide and isotretinoin have REMS

Answer: (D)

REMS programs are safety measures required by the FDA for drugs with serious risks to ensure benefits outweigh those risks. Isotretinoin is covered by a REMS program (iPLEDGE) that enforces strict contraception, pregnancy testing, and enrollment requirements for patients, prescribers, and pharmacies. Thalidomide also has a REMS program (THALOMID REMS) to prevent fetal exposure, with controlled distribution, prescriber and patient registration, counseling, and ongoing pregnancy testing and contraception. Pseudoephedrine is regulated for abuse prevention, but it does not carry a REMS program. So, the statement that thalidomide and isotretinoin have REMS programs is correct.