Accutane and Birth Defects

Serious birth defects represent the most damaging side effect of Accutane. It is, therefore, critically important for women not to take Accutane while pregnant, and not to become pregnant while taking Accutane. Sexually active women who take Accutane must use an effective method of birth control. This usually means oral contraceptive pills and one other additional method of birth control, such as a condom for the male partner. A woman who does get pregnant while on Accutane must be prepared to have an abortion and must state this in writing before many physicians will prescribe Accutane for her. A woman who has taken Accutane should not become pregnant for at least one month after discontinuing treatment.

Risks of Accutane During Pregnancy

Researchers have associated an extremely high risk of fetal malformations in women who become pregnant while taking Accutane. This remains true even in cases where a woman takes a small amount of Accutane for a short period of time. Birth defects associated with Accutane include: hydrocephaly (enlargement of the fluid-filled spaces in the brain), microcephaly (small head), mental retardation, ear and eye abnormalities, cleft lip and palate and other facial abnormalities and heart defects. A high risk of miscarriage also accompanies the use of Accutane in pregnant women. Accutane can cause these birth defects in the early weeks after conception when a woman remains unaware that she is pregnant. Even babies without obvious malformations upon birth may have mental retardation or learning disabilities.

When the FDA approved Accutane, doctors knew the drug was teratogenic - able to cause birth defects. The FDA designated the drug as Category X, meaning that it must be avoided under all circumstances during pregnancy. Nursing mothers also should not use Accutane.

Though not every fetus exposed to Accutane becomes deformed, the risk of birth defects among pregnant women is extremely high. Reports suggest that about twenty-five to thirty-five percent of babies will suffer a malformation after exposure. This does not include defects, such as learning disabilities, that are undetectable at birth.

Though the FDA approved labeling in 1982 that warned pregnant women against using Accutane, reports of severe birth defects associated with the drug began to arrive in June 1983. In the following years, a series of labeling changes and letters to pharmacists and prescribers of the drug stressed pregnancy warnings and sought to increase awareness about reported malformations.

Then, after an FDA review of pregnancy exposures to Accutane, La Roche launched the Pregnancy Prevention Program (PPP) in late 1988 to further educate women using Accutane and their physicians about the associated dangers. The goal was to ensure that doctors would only prescribe the drug to women with severe recalcitrant nodular acne who could comply with contraceptive requirements.

La Roche sent Pregnancy Prevention kits to physicians and encouraged them to review pregnancy prevention materials with female patients before starting the drug. Materials included a contraceptive booklet, checklists to help assess whether patients could adhere to the drug's requirements, and consent forms that patients must sign to acknowledge their understanding of the risk of birth defects. La Roche packages the drug in special blister-packs containing warnings that pregnant women should never use the drug. La Roche also offered to pay for contraceptive counseling and pregnancy testing by a specialist.

Though Accutane labeling recommends the use of two reliable forms of contraception, reports exist of pregnancies occurring in patients who used hormonal contraception, including pills, injectables, and implantables, while taking Accutane. In response the FDA mandated labeling updates to Accutane in the summer of 2000. As part of those updates, the FDA recommends that a woman undergo a pregnancy test one week prior to beginning treatment with Accutane, and that a woman begin Accutane therapy on the second or third day of the woman's next menstrual period. The FDA advises that a woman should use two reliable forms of contraception simultaneously, unless choosing abstinence, for at least one month before throughout therapy with the drug, and for at least one month following discontinuation of Accutane. The FDA recommends that a woman repeat the pregnancy test and contraceptive counseling each month.