Salt Lake Tribune: Acne drug users must report on birth control

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Acne drug users must report on birth control

National registry: In an effort to prevent birth

defects, the Food and Drug Administration has

toughened rules for the use of Accutane

By Tyler

The Salt Lake Tribune

Salt Lake Tribune

Every night before bed, 17-year-old Alison

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.

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.

on, 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. "

, 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 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. "

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