Question 1: What is isotretinoin?
Answer: 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 any other acne treatments, including antibiotics. Isotretinoin capsules 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.
Question 2: What is the iPLEDGE REMS program?
Answer: The iPLEDGE program is an FDA required risk management program with the goal of preventing fetal exposure to isotretinoin. All isotretinoin manufacturers are part of the iPLEDGE program, and health care providers 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 program and agree to meet all the program requirements. Program requirements vary and are determined by the patient’s risk category. iPLEDGE also includes a pregnancy registry for patients who get pregnant during isotretinoin treatment.
Question 3: What is a Risk Evaluation and Mitigation Strategy (REMS)?
Answer: 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 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.
Question 4: When will the changes be implemented?
Answer: The isotretinoin manufacturers are required to submit their proposal 6 months from the date of the letter. FDA has 6 months to review and approve the changes. Once approved, the isotretinoin manufacturers will need time to implement the changes.
Question 5: What do patients who can become pregnant need to know now about the changes?
Answer: All pregnancy tests before you start isotretinoin must be done in a medical setting (e.g., doctor’s office, laboratory). Your doctor may continue to allow you to use home pregnancy tests during and after your isotretinoin treatment. You must communicate the date and pregnancy test result to your doctor as directed. For now, there are no other changes to the requirements.
Question 6: What do patients who cannot become pregnant need to know now about the changes?
Answer: There are no changes to the process for getting your isotretinoin prescription at this time. For information about your requirements, please talk to your doctor.
Question 7: What do prescribers need to know now about the changes?
Answer: Most iPLEDGE requirements remain the same until the iPLEDGE REMS is updated. FDA continues to exercise enforcement discretion with respect to certain requirements. Namely, FDA does not intend to object if prescribers:
- Assess a patient’s pregnancy status using pregnancy tests that are not performed in a CLIA-certified laboratory.
- Rely on the patient to perform home pregnancy tests and report the dates and results of these tests to the prescriber during and after isotretinoin treatment.
All pre-treatment pregnancy tests must be performed in a medical setting (e.g., office, laboratory). Prescribers will continue to be responsible for interpreting and documenting all pregnancy test results in the iPLEDGE REMS system. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests.
FDA and the isotretinoin manufacturers will continue to update you about the timing of additional changes to the program.
Question 8: What do pharmacists need to know now about the changes?
Answer: There are no changes to the process for dispensing isotretinoin at this time. For information about the pharmacy requirements, refer to the iPLEDGE Pharmacist Guide.
Additional Information | Related Information/Quick Links
- iPLEDGE REMS Modification Notification Template (PDF - 204 KB)