Jan. 20, 2000 (Washington) -- If the results of a new CDC study are any indication, physicians and their patients could do a significantly better job of following the warning labels on prescription drugs. The study was designed to draw attention to the fact that women taking Accutane (isotretinoin), a common acne medication known to cause serious birth defects, continued to become pregnant -- despite the start of a pregnancy-prevention program 11 years earlier.
While pregnancies do occur unexpectedly, "the study shows that some of these pregnancies were preventable, and that is of concern," lead author Peggy Honein, PhD, MPH, tells WebMD.
The investigators' conclusions were based on interviews with 14 women residing in California who had reported their pregnancies to either the Boston University Accutane Survey (a program in which all women of childbearing age taking Accutane were asked to enroll) or the California Teratogen Information Service and Clinical Research Center. A teratogen is a substance known to cause birth defects. The interviews included questions on whether the women understood the acne treatment's indications, as well as whether the women could recall advertisements for the prescription drug. The women were also questioned about their pregnancy history, contraceptive use, and the medical tests they underwent when beginning their treatment.
All 14 women responded that they knew Accutane should not be used during pregnancy, but eight also reported having at least one instance of sexual intercourse without using contraception. Thirteen said that they did not use two forms of contraception, as recommended by the pregnancy prevention program. "In the 11 years since the inception of the pregnancy prevention program, less than 40% [of reproductive-aged women taking the drug] have enrolled in the Boston University [Accutane] Survey," says Honein. That means, she says, that "even if there is a low pregnancy rate, we can't discount these results."
"We do need to look closely at why [women taking Accutane are getting pregnant]," says Kate Thomsen, MD, MPH, medical director of Planned Parenthood, the world's oldest and largest family planning organization. In her experience, she tells WebMD, physicians perform a pregnancy test (as recommended on the drug label) on women before prescribing Accutane. However, it may be difficult for both physicians and patients alike to follow all of the drug's many labeling restrictions. Most importantly, the label restrictions cannot account for the pressure on women to have sex at times when they know they should not.
"We are concerned about any pregnancies at all," says Melissa Ziriakus, MA, a director of public affairs at Hoffmann-La Roche, the maker of Accutane. According to Ziriakus, the Nutley, N.J.-based drugmaker is in ongoing discussions with the FDA concerning these events. But a close look at the overall population of reproductive-aged women, she says, shows "that as the use of Accutane increases, the reported rate of fetal exposure doesn't [increase]."
The drug label currently includes a strong recommendation for physicians to obtain a patient's informed consent before being prescribed the drug. This means that the patient understands the risks involved in taking the medication -- a measure usually reserved for patients undergoing surgery or who are involved in experimental trials. But in terms of addressing preventable pregnancies, neither the FDA nor Hoffmann La-Roche could or would say whether any additional steps will be taken to stem this problem.
In the meantime, the CDC will continue to work closely with the FDA to make sure that physicians and patients are aware of the danger, Honein tells WebMD. "It is too easy for this problem to slip out of everybody's mind," she says, "but I hope this experience teaches everyone to be more cautious."
- Physicians and patients need to do a better job of following warnings on drug labels, according to a CDC study.
- Pregnant women continue to be exposed to Accutane, a well-known teratogen, 11 years after the inception of a pregnancy prevention program for women taking the drug.
- The label for Accutane strongly recommends that physicians obtain a patient's informed consent and encourage monthly visits to the dermatologist.