[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Citations 0
From the Food and Drug Administration
February 6, 2002

Risk Management of Accutane

Author Affiliations

Not Available

Not Available

JAMA. 2002;287(5):578. doi:10.1001/jama.287.5.578

The FDA is alerting physicians to the strengthened risk management program for isotretinoin (Accutane, Hoffmann-La Roche Inc, Nutley, NJ), an approved treatment for severe nodular cystic acne. To further protect patients against the drug's risks, which include birth defects and fetal death, the manufacturer has developed in consultation with the FDA a comprehensive program designed to ensure that no woman should begin Accutane therapy if she is pregnant and no pregnancies should occur while the patient is taking the drug.

First Page Preview View Large
First page PDF preview
First page PDF preview