Effectiveness of Pregnancy Prevention Programs
Shortly after the Pregnancy Prevention Program began, La Roche sponsored a survey of women taking Accutane to assess compliance with the program. The survey tracked pregnancy rates and outcomes, patients' awareness of risks, and patient and physician behavior.
Over 500,000 women enrolled in the survey from 1989 to 1998, out of which 958 pregnancies occurred, 834 that resulted in termination (either elective, spontaneous or due to ectopic pregnancies), and 110 that resulted in live births. Of the sixty infants with available medical records, eight had congenital abnormalities. Since Accutane's approval, La Roche has received close to 2,000 reports of Accutane-exposed pregnancies, seventy percent of which occurred after the Pregnancy Prevention Program began.
Most patients in the survey have reported that they understood Accutane might cause birth defects. According to La Roche, the percentage of female patients who were pregnant when they began Accutane dropped from thirty percent of pregnancies reported in 1989 to eleven percent of pregnancies reported for the period of 1991 to 1997.
A 1997 report on the survey shows that twenty-five percent of women in the program did not get a pregnancy test before starting Accutane, and thirty-three percent did not postpone the start of Accutane until receiving pregnancy test results. Researchers estimated that 40 percent of women taking Accutane are sexually active.
FDA's Dermatologic and Ophthalmic Drugs Advisory Committee met in September 2000 to discuss options for Accutane, and to evaluate whether they can develop a safer framework for use of the drug. In response, the FDA has proposed a mandatory registration of pharmacists, prescribers, and patients taking Accutane. Registration would compel doctors to document negative pregnancy tests and require pharmacies to dispense the drug only to women who have had negative pregnancy tests.
The registry for prescribers involves a continuing education course that doctors must satisfy to prescribe Accutane. All Accutane patients must sign a mandatory consent form that addresses both pregnancy and psychiatric issues.
One measure that researchers and physicians believe helps in preventing Accutane complicated pregnancies is the monthly limit on prescriptions. The FDA recommends that doctors give only one-month prescriptions for Accutane and conduct urine or blood pregnancy testing and contraceptive counseling each month of treatment. Pharmacists should not fill prescriptions for Accutane without confirming that the patient underwent a pregnancy test the result of which was negative.
Alternative Acne Medications for Women of Childbearing Age
Most women with acne do not suffer from severe nodular acne, and their skin problems often respond to safe topical or oral medications. Topical preparations of the antibiotics erythromycin or clindamycin represent safe choices even during pregnancy, as does benzoyl peroxide, an antibacterial agent that also dries the skin. If topical preparations do not clear the skin, a woman's doctor may recommend oral treatment with antibiotics such as erythromycin. Doctors have not associated erythromycin with birth defects.
There also are topical retinoids that doctors use to treat acne. While these medications may represent a far safer alternative to oral retinoids during pregnancy, it is best to avoid them during pregnancy because the drug may be absorbed through the skin into the bloodstream.
Other Retinoids Unsafe to Use During Pregnancy
All oral retinoids pose a risk of birth defects and therefore pregnant women should not use them. Women also should avoid pregnancy for varying periods of time after discontinuing use of any oral retinoid. Soriatane is a retinoid La Roche markets for use treating severe psoriasis, a chronic disfiguring skin disease. Like Accutane, this drug can cause serious birth defects, including craniofacial and heart defects, spina bifida and limb defects. Because this drug remains in the system for an extended period, a woman should not become pregnant for at least three years following discontinuation of the drug.
Soriatane replaces a closely related psoriasis drug called Tegison, which remains in a patient's system for an indefinite period. Some doctors recommend that women avoid pregnancy indefinitely after taking Tegison. Any woman who has used Tegison should discuss with a doctor if and when it may be safe for her to attempt pregnancy. Women who take Soriatane should not drink any alcoholic beverages while they are taking the drug or for two months afterward, as this combination causes the body to turn Soriatane into Tegison.
Another retinoid called tretinoin,
comes in topical versions, including Retin-A and Renova
that also treat acne as well as sun-damaged skin. Studies to
date suggest that topical tretinoin does not appear to cause
birth defects. Some questions about its safety in pregnancy remain,
due to a few reports of birth defects in babies of women who
used these preparations during pregnancy. Until more is known
about the safety of topical tretinoin during pregnancy, women
who are pregnant or planning pregnancy should avoid these medications.