 |
|
Risk Management of Accutane
JAMA. 2002;287:578.
|
|
| Since this article does not have an abstract, we have provided the first 143 words of the full text and any section headings. |
|
|
|
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.
The new requirements include the prescriber's familiarity with the manufacturer's "Guide to Best Practices"; attachment of special qualification stickers to Accutane prescriptions attesting to negative urine or serum pregnancy tests before and during therapy; and, for sexually active patients, use of two forms of contraception. For more details, visit http://www.fda.gov/cder/drug/infopage/accutane/default.htm.
AUTHOR INFORMATION
Written inquiries may be directed to Office of the Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857.
Bernard A. Schwetz, DVM,PhD
Acting Principal Deputy Commissioner
Food and Drug Administration
|
