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Contraceptive failure, nonuse cited as primary causes. Meticulous follow-up and documentation is necessary monitoring by prescribing physician

Recommended steps for pregnancy prevention in patients treated with isotretinoin

Perform two pregnancy tests

Confirm negativity of the second pregnancy test before giving prescription

Confirm that the patient is using two forms of contraception if sexually active

Write out only one month supply of drug at a time

Reinforce the necessity of monthly pregnancy testing and counseling

Washington — Despite recommendations for strict measures of pregnancy prevention, four out of 1,000 women undergoing treatment with isotretinoin (Accutane), a known teratogen, become pregnant, reported Diane M. Thiboutot, M.D.

“Isotretinoin remains the single most effective agent for severe acne. It has improved acne and prevented permanent scarring in millions of patients treated over the years,” said Dr. Thiboutot, at the 59^th annual meeting of the American Academy of Dermatology. “[Yet] I was surprised at the number of women who still become pregnant either before or during treatment.” web site countdown to pregnancy

The rate of four pregnancies per 1,000 women treated, Dr. Thiboutot said, may be surprising to clinicians. Of these pregnancies, 26 percent occurred prior to treatment, while 14 percent of these women were pregnant at the time of the initial visit. Another 12 percent of women who became pregnant did not follow physician’s instructions to wait until their next menstrual period to begin taking isotretinoin.

Despite strict birth control recommendations and counseling, 64 percent who became pregnant did so during therapy. Of these, 11 percent reported that they failed to maintain abstinence. A full 34 percent had chosen a birth control method but had failed to use it at the time of conception. see here countdown to pregnancy

More disturbing, 51 percent reported contraceptive failure — the basis for the recommendation that two methods of birth control be used in women who are sexually active and being treated with isotretinoin; said Dr. Thiboutot, associate professor, medicine, Milton S. Hershey Medical Center, College of Medicine, Penn State University, Hershey, Pa.

Myriad contributing factors

Patient confusion with respect to the timing of pregnancy testing and contraception was widespread. “In some cases, pregnancy testing was not done on the second or third day of the next menstrual period as is recommended,” she said.

According to data from individual pregnancy reports, false-negative tests, misinformation about contraception, and no monthly pregnancy testing or contraceptive counseling were also reported as contributing factors. In addition, some patients received more than a one-month supply of isotretinoin at once, which may have led to irregularities in follow-up. “We need to prescribe only one month of medication at a time, so we can be assured of adequate follow-up,” Dr. Thiboutot noted.

Some patients reported receiving no monthly pregnancy testing or contraceptive counseling from their dermatologist, she said. For pregnancy prevention in these patients, Dr. Thiboutot said, clinicians must carefully follow these patients and meticulously document the measures they have taken.

“It is important to document this information in our notes; mainly the initial pregnancy test, confirmation of the second test as negative, and then of the monthly testing;’ she said. “We need to educate ourselves and our patients. We need to closely monitor them in terms of safety issues.”

Updated recommendations

As a result of a recent review of the data, changes have been made in the labeling of isotretinoin, as well as in recommendations for clinicians. Two pregnancy tests are now required at specific times in women of childbearing age who are to be treated with isotretinoin. The first is to be done at the initial visit when the decision to treat with isotretinoin is made. The second is to be done on the second or third day of the patient’s next menstrual period.

Roche Laboratories provides a home pregnancy test with the prescription, Dr. Thiboutot said. Accuracy is 99 percent at 11 days postconception, she said.

Additional recommendations are that women use two forms of contraception. Primary methods include tubal ligation, vasectomy, oral contraceptives, injectable or implantable contraceptives, and intrauterine devices. Secondary means of contraception include diaphragms with spermicide, latex condoms with spermicide, and cervical caps with spermicide.

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