As expected, the Food and Drug Administration has relaxed some of the rules for prescribing the acne drug isotretinoin, including eliminating the 23-day lockout period for women of childbearing potential.
Women still must have their initial prescription filled within 7 days of their first office visit or they will be prevented from getting the drug for 23 days. But the restriction no longer will apply to succeeding prescriptions.
Dermatologists, drugmakers, and professional organizations such as the American Academy of Dermatology had encouraged the FDA to make that change to the iPLEDGE program that governs isotretinoin prescribing.
At a meeting in August, the FDA's Dermatologic and Ophthalmic Drugs and Drug Safety and Risk Management advisory committees voted unanimously in support of eliminating the 23-day lockout and several other changes, which the agency also approved. Those included:
▸ Starting the 7-day window for the initial prescription for those of childbearing potential from the date of pregnancy testing, instead of the date of the office visit.
▸ Extending the prescription window from 7 days to 30 days for men and for women not of childbearing potential.
▸ Modifying the list of acceptable secondary forms of contraception to include male condoms with or without spermicide.
The changes will be effective Dec. 2. Updated materials will be sent to pharmacies and prescribers before then, said Roche Laboratories Inc., one of the isotretinoin manufacturers. The others are Mylan Laboratories Inc., Ranbaxy Laboratories Ltd., and Barr Pharmaceuticals Inc.
The committee members said iPLEDGE seemed to be interfering with the doctor-patient relationship and had not, despite all its restrictions, eliminated pregnancies. From March 2006 to March 31, 2007, there were 122 pregnancies in 91,894 women of childbearing potential who received a prescription.
There were 37 pregnancies in April, May, and June 2007, and 19 pregnancies outside the iPLEDGE program, Roche officials noted at the meeting.