November 1, 2001
Roche Announces FDA Approval of Enhanced Pregnancy Prevention
Program for Accutane
- Hoffmann-La Roche Inc., working in cooperation with the US Food and
Drug Administration (FDA), announced today that FDA has approved an enhanced
version of Roche's Pregnancy Prevention Program for Women on Accutane(R)
The revised program is intended to assist physicians, patients and
pharmacists in further reducing the number of pregnancies among women taking Accutane (isotretinoin), Roche's product for severe recalcitrant nodular
acne, because of the medication's risk of causing birth defects. The Roche
program, called SMART(TM), for System to Manage Accutane Related
Teratogenicity, consists of informational brochures for physicians,
pharmacists and patients as well as letters explaining the new aspects of
the program. It will be distributed to physicians, pharmacists and patients
in January 2002.
This state-of-the-art program is intended to integrate the flow of
information among Accutane patients, physicians and pharmacists. The goal is
to document that female patients are not pregnant when they start taking
Accutane, and do not become pregnant while on the medication.
Accutane is a highly effective treatment for severe recalcitrant nodular
acne that has not been controlled effectively by other therapies. Severe
nodular acne can cause permanent scarring if not properly treated. The
medication's risk of causing birth defects has been known since it was first
marketed, and pregnancy prevention education programs have been in place for
patients and doctors since 1988.