New warning about acutane and birth defects

FDA Consumer, Oct, 1988 by Judith Willis

The patient labeling will also state that there is at least a one in four chance that a woman who becomes pregnant while taking Accutane will give birth to a deformed baby. The patient consent form, which the woman and her physician must sign, will include a discussion of the potential for birth defects. To prevent starting the drug when a pregnancy has begun but is not yet recognized, the patient leaflet will instruct the woman that the drug should be started only on the second or third day after the start of a normal menstrual period. A phone number will be given for women to call if they think they may be pregnant and want additional information.

The "don't use in pregnancy" symbol (a pregnant woman within a bisected circle, the international symbol for "not" or "don't") will be displayed both on each page of the patient leaflet and on each panel of the new blister-pack packaging. The blister pack will include a tear-off prepaid postcard addressed to Hoffmann-La Roche on which the patient can inform the company of her name, phone number, and address, and grant permission to the company to contact her for follow-up studies to determine whether women taking Accutane are continuing to become pregnant.

The physician labeling, which will also display the "don't use in pregnancy" symbol, will be extensively revised to more strongly emphasize the risk of birth defects. The print size for the boxed pregnancy contraindication will be doubled. The boxed warning will forbid Accutane's use in women of childbearing age unless all of the following conditions are met:

* The patient has severe, disfiguring cystic acne that does not respond to other therapies.

* She is reliable in understanding and carrying out instructions.

* She is capable of complying with mandatory contraceptive measures.

* She has received both verbal and written warnings of the hazards of pregnancy, the risks of contraceptive failure, and has acknowledged these in writing.

* Within two weeks before starting the drug, the patient has had a negative pregnancy test, performed in a physician's office or by a licensed laboratory.

The physician labeling will also contain instructions that Accutane should be prescribed only by physicians, such as dermatologists, who have special competence in the diagnosis and treatment of severe, recalcitrant cystic acne, and who understand the risk of birth defects.

In addition to the labeling changes, Hoffmann-La Roche has agreed to extensive professional educational and follow-up efforts. The firm will report to FDA all cases in which a woman using Accutane becomes pregnant, whether or not a birth defect or other adverse reaction occurs. It also will undertake research into the reasons why, despite warnings, pregnancies have occurred int he past. Data concerning the use of the drug, including information about age and sex of patients, will be supplied to FDA quarterly. The company is also designing studies using lower doses of the drug, and using higher doses for a shorter period.