For many women, the decision to take Accutane was one of desperation. The drug was considered a last resort to treat severe acne using the active ingredient isotretinoin. While the drug may have worked to clear up cystic and chronic acne, it had irreversible effects for the children of women taking it.
In the months after Accutane was approved by the FDA, the agency received reports of a high rate of birth defects in mothers who had taken the medication. Defects included cleft palate, facial disfigurement, ear malformations, heart defects, and brain damage—and some expectant mothers experienced spontaneous abortions of their fetuses during the first trimester.
While the manufacturer stopped making Accutane in June 2009, there are still many generic forms of isotretinoin available on the U.S. market. The FDA has now classified isotretinoin as Category X, with a warning to all physicians of how and when the drug should be administered to women:
- Isotretinoin should never be used by women who are pregnant or who may become pregnant while taking the medication.
- Women should be made fully aware of the risks of major birth defects as a result of becoming pregnant during isotretinoin therapy. If pregnancy occurs during treatment, patients should consult their physicians immediately about the management of their pregnancy.
- Patients should use effective contraception for at least one month prior to treatment, and throughout the length of time they are being treated with isotretinoin.
- Patients should be tested to rule out possible pregnancy before treatment begins. Doctors should obtain a negative pregnancy test no more than two weeks prior to the beginning of treatment, with treatment beginning on the second or third day of the patient's next menstrual period.
- Women who have completed isotretinoin treatment should continue using an effective form of contraception for at least one month after taking their final dose of medication.
- Patients should be counseled not to share prescription isotretinoin with their friends or family members.
What If My Doctor Failed to Warn Me of the Side Effects of Accutane?
Your doctor has a duty to properly inform you of the risks of all medication before you begin your treatment. If your child suffered birth defects due to isotretinoin, we can investigate your case and determine what you may be owed. Call Wayne Wright LLP at 800-237-3334 today to begin your free case evaluation!