Posted on: Sunday, March 3, 2002

Acne drug prescribers to get psychiatric advice leaflet

By Rita Rubin
USA Today

In the next month or so, the maker of the popular acne medication Accutane will be mailing dermatologists and other prescribers copies of a new brochure on how to recognize psychiatric disorders in adolescents and young adults, a company spokeswoman said.

Some parents, including Rep. Bart Stupak, D-Mich., have blamed Accutane for their teenagers' suicides, although maker Hoffman-La Roche maintains there is no scientific evidence to support that notion. In fact, the company argues that Accutane users, who total in the millions since 1982, actually have a lower suicide rate than the general public.

The new brochure, developed by Roche in conjunction with the Food and Drug Administration, is the final piece in a program designed to minimize the risk of adverse effects in Accutane users, says FDA spokeswoman Kathleen Kolar. The drug's main known risk is that of birth defects in children born to women who take Accutane while pregnant.

Last year, the FDA began requiring pharmacists to dispense plain-English "medication guides" with every Accutane prescription they dispense. At the same time, Roche also began providing a patient consent form focusing on psychiatric problems.

Company spokeswoman Carolyn Glynn said that depression is not uncommon among people 15 to 24 years of age, the group most likely to seek acne treatment.