"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.