ACCUTANE Treatment

What are the important warnings for females taking Accutane?

You must not become pregnant while taking Accutane, or for 1 month after you stop taking Accutane. Accutane can cause severe birth defects in babies of women who take it while they are pregnant, even if they take Accutane for only a short time. There is an extremely high risk that your baby will be deformed or will die if you are pregnant while taking Accutane. Taking Accutane also increases the chance of miscarriage and premature births.

Female patients will not get their first prescription for Accutane unless there is proof they have had 2 negative pregnancy tests. The first test must be done when your prescriber decides to prescribe Accutane. The second pregnancy test must be done during the first 5 days of the menstrual period right before starting Accutane therapy, or as instructed by your prescriber. Each month of treatment, you must have a negative result from a urine or serum pregnancy test. Female patients cannot get another prescription for Accutane unless there is proof that they have had a negative pregnancy test.

A yellow self-adhesive Accutane Qualification Sticker on your prescription indicates to the pharmacist that you are qualified by your prescriber to get Accutane.

While you are taking Accutane, you must use effective birth control. You must use 2 separate effective forms of birth control at the same time for at least 1 month before starting Accutane, while you take it, and for 1 month after you stop taking it. You can either discuss effective birth control methods with your prescriber or go for a free visit to discuss birth control with another physician or family planning expert. Your prescriber can arrange this free visit, which will be paid for by the manufacturer.

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You must use 2 separate forms of effective birth control because any method, including birth control pills and sterilization, can fail. There are only 2 reasons you would not need to use 2 separate methods of effective birth control:

1/ You have had your womb removed by surgery (a hysterectomy).
2/ You are absolutely certain you will not have genital-to-genital sexual contact with a male before, during, and for 1 month after Accutane treatment.

If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your period, stop using Accutane and call your prescriber right away. - - FDA/Center for Drug Evaluation and Research

Continued - What is ACCUTANE?

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