Physicians urged to participate in new program for Accutane.(Brief Article)

1902 MAR 28 - (NewsRx.com & NewsRx.net) -- by Lynn Yoffee, senior medical writer - Considered the biggest breakthrough in acne treatment in 2 decades, isotretinoin (Accutane) for severe recalcitrant nodular cystic acne comes with risks, especially for women.

With sales of $757 million a year, isotretinoin has been linked to fetal abnormalities (8 reported cases), fetal death (834 terminated pregnancies either elective, spontaneous, or ectopic), and adverse psychiatric events including depression, psychosis, suicidal ideation, suicidal attempts, and suicide (24 reported deaths).

Barbara R. Reed, MD, clinical associate professor of dermatology, University of Colorado, Denver, updated attendees at the American Academy of Dermatology's 60th Annual Meeting in New Orleans about recent efforts to strengthen a risk management program.

The new program, called SMART (System to Manage Accutane-Related Teratogenicity) was developed by Accutane's manufacturer, Roche Laboratories, of Nutley, New Jersey, in consultation with the U.S. Food and Drug Administration. Reed was part of an AAD task force that provided advice on the program.

"We reviewed all of the documents and responded and we'll publish our ...