What unique obligation is associated with Isotretinoin treatment?

Isotretinoin, a medication primarily used to treat severe acne, comes with specific regulations due to its potential for serious side effects, particularly teratogenicity. The I-PLEDGE program is a risk management strategy designed to prevent fetal exposure to the drug. It requires healthcare providers, patients, and pharmacies to enroll in a registry before initiating isotretinoin treatment. This program mandates that female patients demonstrate effective birth control, have regular pregnancy tests, and agree to follow strict guidelines during and after treatment to mitigate risks associated with administering this potent medication.

This unique obligation emphasizes the importance of preventing pregnancy due to the high risk of severe birth defects if the medication is taken during pregnancy. Therefore, adherence to the I-PLEDGE program is not just a recommendation; it is a requirement for anyone prescribed isotretinoin, signifying its critical nature in the management of the risks associated with the drug.