Accutane & Pregnancy
Accutane, the brand name of the medication isotretinoin, treats severe nodular acne. Although this medication successfully reduces acne for many people, it may cause life-threatening birth defects when taken during pregnancy. Pregnant women and women who may become pregnant should avoid using Accutane.
Taking Accutane during pregnancy can cause severe and life-threatening birth defects. Documented birth defects following exposure to Accutane include abnormalities of the central nervous system, cardiovascular system, thymus and parathyroid glands, face, eyes, ears and skull. The iPLEDGE official website notes that some of these abnormalities caused fatalities. Reports of an increased risk of miscarriage and premature births also occurred.
Women who could become pregnant must participate in a risk-management program called iPLEDGE to get a prescription for Accutane. The two goals of this program are to ensure that no woman starts taking Accutane when pregnant and to ensure no woman taking Accutane becomes pregnant, according to the iPLEDGE official website. Women must participate in the iPLEDGE program the entire time they take Accutane.
iPLEDGE Requirements for Women of Childbearing Potential
All women are considered to be of child-bearing potential unless they have had a total hysterectomy or have been in menopause for 12 consecutive months. The iPLEDGe program requires women to agree in writing to use two specific forms of birth control, including one primary form of birth control and one secondary form of birth control. Primary birth control methods include tubal ligation or vasectomy, intrauterine devices, estrogen-containing birth control pills, the vaginal ring and the birth control patch, injection or implant. Secondary forms of birth control include the combination of spermicide and a condom, diaphragm, cervical cap or vaginal sponge. Women must agree to start using these forms of birth control 30 days before beginning Accutane treatment and continue using the forms of birth control until 30 days after they stop using it. Women must also have two negative pregnancy tests before receiving a Accutane prescription. They can take the first test in their doctor's office, but they must go to a CLIA-certified laboratory for the second pregnancy test. In addition, they must go to a CLIA-certified laboratory each month for additional pregnancy tests before the monthly prescription can be renewed, according to the official website of iPLEDGE.
Alternative Acne Treatment for Pregnant Women
Women with acne may consider other treatments during acne. The March of Dimes notes that topical medications, such as erythromycin or clindamycin, can safely treat acne during pregnancy. Pregnant women may also consider products containing benzoyl peroxide, an antibacterial agent that dries the skin. Research about the safety of topical retinoids is inconclusive, so pregnant women should avoid using these medications until researchers learn more about their safety.
Women who have unprotected sex or miss a period while on Accutane should stop using the medication immediately and call a doctor immediately. An obstetrician-gynecologist with experience in reproductive toxicity can provide medical advice about the situation, as well as explain what evaluation options are available to determine whether the medication has affected the baby.
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