Reducing fetal exposures: more isotretinoin restrictions likely.(News)

GAITHERSBURG, MD. -- The current risk management program for isotretinoin has failed, and a more stringent program is needed to reduce fetal exposures to the drug, members of two Food and Drug Administration advisory panels agreed at a recent meeting here.

At a 2-day meeting of the FDA's Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee, panel members voted 16 to 8 in favor of adopting a more restrictive risk management program that was proposed by Accutane manufacturer Roche and generally agreed upon by the three manufacturers of generic isotretinoin.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

The proposed program, based in part on the risk management programs for clozapine and thalidomide, would include a centralized registry of patients, physicians, and pharmacists; a link between all three; and a patient identification number for each patient, which registered pharmacists could use to check pregnancy test results before filling the prescription.

The eight dissenting panelists--mostly dermatologists--supported a proposal that the manufacturers first study the cost and effectiveness of Roche's proposed plan before nationwide adoption, as recommended by Dr. Michael Wilkerson, a dermatologist in Tulsa, Okla.

"The [proposed] program does not, in my view, add anything but more layers of complications that may actually lead to less compliance," he said.

Dr. Sharon Raimer, professor and chair of dermatology at University of Texas Medical Branch, Galveston, pointed out that while the System for Thalidomide Education and Prescribing Safety (STEPS) has been highly effective in an older, sicker population, a pilot study would be needed to learn whether similar elements would be as effective in the younger, healthier population of isotretinoin users.