Change in iPledge Program for Isotretinoin

The iPledge program is a risk management program to reduce the possibility of fetal exposure to the acne drug isotretinoin, which can cause serious birth defects if taken during pregnancy. Isotretinoin is sold under the brand names Accutane, Amnesteen, Claravis and Sotret.

Briefly, iPledge requires registration of wholesalers, prescribers, pharmacies and patients, both women and men. The program also requires that women capable of becoming pregnant have two negative pregnancy tests before the drug can be prescribed for them, and a negative pregnancy test each month while taking the drug.

A recent change to the program will make it easier for certain patients to get isotretinoin without compromising protection of the fetus. Until now, all patients prescribed isotretinoin had to fill their prescription within seven days of their office visit. If a patient missed this seven day window, the prescription could not be filled for another 23 days, in order to prevent possible exposure of a newly formed embryo. Under the new change, this "lockout period" is eliminated for male patients and for females of non-childbearing potential. The change does not affect women of childbearing potential.

Category:

News & Politics

Tags:

• iPledge
• Isotretinoin
• FDA
• Fetal
• Exposure
• Birth
• Defects
• Accutane
• Amnesteen
• Claravis
• Sotret
• Patient
• Safety