Q1. What is isotretinoin?

A1. Isotretinoin is a prescription medicine approved for use in patients 12 years of age and older, who are not pregnant, for the treatment of severe acne (nodular acne) that cannot be cleared up by other acne treatments, including antibiotics. Isotretinoin can cause serious side effects, including birth defects. Because of the risk of severe birth defects, isotretinoin has only been available through a restricted distribution program called the iPLEDGE Program since 2005 and approved as the iPLEDGE REMS in 2010.

Q2. What is a Risk Evaluation and Mitigation Strategy (REMS)?

A2. A REMS is a risk management program that uses risk minimization strategies beyond approved labeling to manage serious risks associated with a drug. Under the Food and Drug Administration Amendments Act of 2007, FDA has the authority to require a manufacturer to develop and implement a REMS when FDA finds it is necessary to ensure that the benefits of a drug outweigh its risks.

A REMS can include a Medication Guide or patient package insert, communication plan, one or more elements to ensure safe use, an implementation system, and/or a timetable for submission of the REMS assessments. A REMS may also include certain packaging and safe disposal technologies for drugs that pose a serious risk of abuse or overdose.

Q3. What is the iPLEDGE REMS?

A3. The iPLEDGE REMS is an FDA-required risk management program with the goal of preventing fetal exposure to isotretinoin. All isotretinoin manufacturers are part of the iPLEDGE REMS, and health care professionals and pharmacies must be registered with iPLEDGE to be able to prescribe and dispense isotretinoin to patients.

To receive isotretinoin, patients must also be enrolled in the iPLEDGE REMS and agree to meet all the REMS requirements. The REMS requirements for patients vary and are determined by the patient’s category. iPLEDGE also includes a pregnancy registry for patients who get pregnant during isotretinoin treatment.

Q4: What are the Feb. 9, 2026 changes to the modified iPLEDGE REMS?

A4: FDA approved changes to the iPLEDGE REMS on Feb. 9, 2026 that are intended to minimize burden on patients, prescribers, and pharmacies while maintaining the safe use of isotretinoin. These changes include giving prescribers the option to allow patients to complete pregnancy tests outside of a medical setting (e.g. at-home pregnancy tests) during and after treatment, removing the waiting period requirement for repeat pregnancy tests for patients who missed their first 7-day prescription window, and removing the requirement for monthly documentation of counseling for patients who cannot get pregnant.

A summary is available on the FDA iPLEDGE REMS webpage. For complete information on the new iPLEDGE REMS requirements, please visit the iPLEDGE REMS websiteor contact the iPLEDGE REMS Contact Center at 866-495-0654.

Q5: Why do the pregnancy tests before treatment initiation have to be done in a medical setting?

A5: Ensuring patients are not pregnant prior to starting treatment is critically important in preventing fetal exposure to isotretinoin. Performing all pre-treatment pregnancy tests in a medical setting provides additional assurance that a patient who is starting isotretinoin is not pregnant.

Q6: Why did FDA approve these changes now?

A6: In November 2023, FDA notified isotretinoin manufacturers that they need to make modifications to the iPLEDGE REMS to minimize the burden on the health care delivery system while complying with the iPLEDGE REMS. In making this determination, FDA evaluated the iPLEDGE REMS and considered advice from the March 2023 Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee meeting as well as public feedback. The modifications approved Feb. 9, 2026 also include additional changes proposed by the isotretinoin manufacturers.

FDA has considered the impact of the collective changes and determined the modifications will minimize burden for patients, prescribers, and pharmacists while continuing to ensure the benefits outweigh the risk of embryo-fetal toxicity (life-threatening severe birth defects).

Q7: What should patients, prescribers, and pharmacists know about the Feb. 9, 2026 changes to the iPLEDGE REMS?

A7: A summary of the important changes for each group is available on the FDA iPLEDGE REMS webpage. For complete information on the new iPLEDGE REMS requirements, please visit the iPLEDGE REMS website or contact the iPLEDGE REMS Contact Center at 866-495-0654.