Warning: Before you decide to take ACCUTANE^™, you must have discussed the consequences of becoming pregnant during ACCUTANE therapy with your doctor, and clearly understood them. 

ACCUTANE can cause deformed babies, loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. There is an extremely high risk that your baby will be deformed if you are pregnant while taking ACCUTANE or up to one month after treatment has stopped. This risk exists even if ACCUTANE is taken for a short time. Therefore, adequate birth control measures are essential when taking ACCUTANE.

Contraception: Effective contraception must be used for at least one month before starting ACCUTANE treatment, during treatment and for at least one month following the discontinuation of ACCUTANE treatment.

It is recommended that two reliable forms (Primary and Barrier forms) of contraception be used simultaneously. At least one of these forms of contraception must be a primary form (i.e. oral contraceptive, contraceptive patch, vaginal ring, intra-uterine device), unless the patient has undergone a hysterectomy. Remember, any birth control method can fail.

If you are a female of childbearing age, your physician should have discussed this risk with you, and explained how to avoid becoming pregnant while taking ACCUTANE.

Some birth defects commonly associated with taking ACCUTANE during pregnancy are:

• Low-set, deformed or absent ears
• Wide-set eyes
• Depressed bridge of nose
• Enlarged head
• Small chin

More severe birth defects are:

• Mental retardation
• Internal defects affecting the brain, heart, lymph glands, and nervous system