This is an archived article that was published on sltrib.com in 2005, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.
Every night before bed, 17-year-old Alison Smith swallows a birth control pill. The Murray High School senior is abstinent - but to keep her skin clear, she uses Accutane.
The drug is a powerful solution for chronic acne, but it also causes severe birth defects in infants exposed to it during pregnancy. While previous regulations required girls and women taking Accutane to also use two forms of birth control, pregnancies still occur - which has led to Food and Drug Administration (FDA) to announce even stricter rules.
Today, the FDA will open a new computerized national registry that every patient, doctor and pharmacy taking, prescribing or dispensing Accutane will have to join by Oct. 31. Each month, women will be required to enter, by phone or Internet, their two contraceptives.
The new program, called iPLEDGE, also requires all patients to sign a document stating they are aware of the risks of Accutane and generic isotretinoin, including the possibility it may cause depression or suicidal thoughts.
Smith has not minded previous restrictions, glad to abandon the mask of makeup she would apply even to go to a gym. After she tried "everything" else, a generic form of Accutane is working for her.
Taking birth control "is definitely annoying because I'm not sexually active, but at the same time it's definitely worth it," she said.
Julia Robertson, program coordinator for Utah's Pregnancy RiskLine, praises the new rules. Isotretinoin exposure leads to head and face malformations, heart defects and developmental disabilities in infants.
"Isotretinoin is an important medicine, but we feel that there have been too many unintended pregnancies [and] that there is a failure in the system," she said. "We should go for zero pregnancies with exposure. Isn't that reasonable?"
Utah does not track pregnancies among isotretinoin users, but such reporting will be required by the new rules. Since the drug began selling in 1982, the FDA has reports of more than 2,000 pregnancies among users.
Holladay dermatologist LeonÂard Swinyer is a member of the Isotretinoin Advising Committee, which helped the FDA draft the new rules. He isn't sure the registry will help.
"I don't know how it's going to stop people from getting pregnant. You're not there on Saturday night to know what's going on," he said.
Swinyer has been cautious about recommending Accutane treatment, which costs $4,000 to $5,000 but is usually covered by insurance. He sends every female potential patient to an obstetrician-gynecologist for counseling, and won't write a prescription until the obstetrician has told him he or she believes the patient will comply with birth control directions.
None of his patients has become pregnant while using the drug.
At times, the dermatologist sees parents become offended by the birth control requirement. "They get fired up about that kind of thing," he said.
Patients and parents are more aware of the risks of the drug now, and "more today say they want to think about it for a while," he said. He has had three patients who developed depression, which disappeared when they stopped using Accutane.
Still, he adds: "It's a wonderful drug for the right person."
Swinyer hopes the added registry will reduce Accutane pregnancies, but fears it will just make prescribing the drug more difficult.
"We'll probably have to assign one or two medical assistants just to do the Accutane," he said. "There's an awful lot of paperwork to go through."
Brian Williams, a dermatologist in Murray, agrees. He predicts general practitioners will stop prescribing the drug because of the extra paperwork.
The drug isn't right for everybody. Centerville resident Natalie Fisher, 22, used Accutane about five years ago, but quit because she felt certain side effects were worse than the acne - such as dry skin, lips and eyes.
"It dries out everything inside and outside of your body," she said.
If she hadn't stopped then, the registry might have stopped her now, she said. The registry "would have deterred me a little bit. . . . I think I would have backed out."