FRIDAY, Oct. 14, 2005 (HealthDay News) -- Women who take Accutane, a popular acne drug known to cause birth defects, are inconsistent about complying with guidelines to ensure they don't get pregnant while on the drug, a new study found.
The result has been a high rate of abortions and the birth of at least one baby with severe birth defects, the researchers behind the small study said.
Julia Robertson is coordinator of the Birth Defects and Genetics Program at the Utah Department of Health in Salt Lake City, and lead author of the study that followed 34 women who became pregnant while using isotretinoin, sold commonly as Accutane. Her review found that manufacturer-recommended guidelines were often not followed, putting pregnant women at risk for babies with severe birth defects as well as doubling their risk for premature delivery.
"The survey confirmed our concerns that the manufacturer's program wasn't being followed by women and doctors," she said, "and one of the reasons is that it wasn't mandatory."
The results of Robertson's study appear online Oct. 14 in the journal Birth Defects Research (Part A): Clinical and Molecular Teratology.
The U.S. Food and Drug Administration, already aware of this problem, will launch a mandatory registry starting Dec. 31 to track all isotretinoin prescriptions. Called the iPLEDGE system, it will require pharmacists to participate in a registry that tracks who is getting the drug and to check the registry before giving prescriptions to women of child-bearing age. Women taking the drug will have to register with this database, submitting proof of valid negative pregnancy tests to receive the drug.
Robertson, a teratology (birth defects) counselor at the Utah agency for 12 years, said her call-in service began getting more inquiries for help in recent years from women who became pregnant while taking isotretinoin. The drug is known to cause severe birth defects in approximately one-third of babies born to women who take it while pregnant, the study said.
"We got a few a year, but in 2000 we got 13 calls," Robertson said, adding that other counselors throughout the country were experiencing similar increases in calls.
Since Accutane's manufacturer, Roche Pharmaceuticals, had published clear, voluntary guidelines for both doctors and patients to help avoid pregnancy, Robertson and her colleagues decided to survey the pregnant women to find out how they had gotten pregnant.
The guidelines for Accutane use for women of child-bearing age -- called System to Manage Accutane Related Teratogenicity (SMART) -- include: prescription of the drug for "severe recalcitrant nodular acne"; signing an informed consent form; two negative pregnancy tests before starting the drug; a negative pregnancy test each month to renew the prescription; and the use of two forms of birth control while on the drug.
Robertson and her colleagues found that among the 34 pregnant women in her survey, all but three were prescribed isotretinoin for skin problems, yet only 11 were taking the drug for the severe, nodular acne. Also, only 18 of the women signed an informed consent form, and most received the drug from dermatologists and recalled receiving information about the risk of birth defects if they became pregnant while on the drug, mostly from reading the package inserts. However, only eight remembered receiving personal counseling about potential birth defects before starting on the drug.
Also, eight did not have two pregnancy tests before starting the drug; only six used two forms of birth control as recommended; and just over half, 19 women, recalled submitting valid negative pregnancy tests before renewing their prescriptions each month. Only six women enrolled in the manufacturer's voluntary survey and none of the women knew if her medical provider had alerted the FDA of an isotretinoin-exposed pregnancy.
Accutane was the most commonly prescribed isotretinoin among the women in the study, used by 73 percent. The next most commonly prescribed version was Amnesteem, used by 12 percent of the women.
In follow-ups of pregnancies of women in the study, 14 (41 percent) ended in abortion, and three resulted in miscarriage. Twelve of the women (35 percent) delivered babies and one had severe heart defects and seizures, the study found.
"Every time I read these results, I continue to get furious," Robertson said. "Why weren't the regulations followed?"
Dr. Jill Lindstrom, clinical team leader in the division of dermatologic and dental drug products for the FDA and a dermatologist, said it was this lack of compliance with the SMART program that led to the new iPLEDGE mandatory guidelines.
"When the SMART program was initially approved, we specified that we would look at the results after a year. But at that time we found that the number of reported pregnancies was not decreasing, so additional steps had to be taken."
The result, Lindstrom said, is the mandatory guidelines that should ensure the drug is used safely.
"We want every patient that is prescribed isotretinoin to have the drug prescribed in a way that is safe. And in an attempt to achieve that, we have approved the iPLEDGE program," she said.
Dr. Virginia Chen, a dermatologist at the Mount Sinai Medical Center in New York City, said she prescribes isotretinoin for less than 10 percent of her female patients. But requirements that she register her patients online would discourage her from prescribing it.
"I'm not an online access type of doctor," she said.
Visit the U.S. Food and Drug Administration to learn the latest information on the upcoming iPLEDGE guidelines for Accutane use.