Safety Alerts Saves Lives
Safety Alerts  
Home Privacy About Us Contact Us Change Preferences
spacer.gif (43 bytes)
November 1, 2001

Roche Announces FDA Approval of Enhanced Pregnancy Prevention Program for Accutane


 (SafetyAlerts) -  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) (PPP).

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.

Source: PRNewswire.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.


The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.