More than skin deep


As of the beginning of this year, the companies that make the acne drug isotretinoin, best known as Accutane, together with the Food and Drug Administration, have imposed mandatory prescribing rules. Any woman of childbearing age who is given the drug must meet several requirements.

KRT
Published: Wednesday, January 18, 2006 at 6:01 a.m.
Last Modified: Wednesday, January 18, 2006 at 12:03 a.m.
Janine Carpenter arrived at Columbia University in September with a complexion as clear as her bright blue eyes. But during her first month of college, her face began breaking out in pimples and deep, inflamed nodules, the same symptoms that had plagued her early in high school in San Jose, Calif. "My acne just immediately started to come back at a really rapid rate," Carpenter, 18, said. So her doctor gave her the potent acne drug isotretinoin, best known as Accutane.
The prescription came with a bright yellow label assuring the pharmacist that Carpenter was not pregnant, because Accutane can cause severe birth defects. She agreed to also have a pregnancy test each month before refilling her prescription, even though she takes birth control pills. These precautions were part of a program organized by the makers of Accutane and other brands of isotretinoin (Amnesteem, Claravis and Sotret) meant to prevent pregnancy in women taking the drug.
But voluntary programs like this, which have existed since the drug became available in 1982, were not entirely successful. Two to three out of 1,000 women taking isotretinoin still became pregnant, a survey of nearly 450,000 patients, conducted at Boston University from 1989 to 2003, found.
So, as of the beginning of this year, the companies that make isotretinoin, together with the Food and Drug Administration, have imposed mandatory prescribing rules. Any woman of childbearing age who is given the drug must meet several requirements. Before starting the medication she must have negative pregnancy tests two months in a row. While taking it, she must either promise in writing to abstain from sex with a man or else use two forms of contraception, one of which must be a highly effective kind like birth control pills or the injectable Depo-Provera. Each month during her treatment (usually five months) she must take a pregnancy test. And she must document every step she takes by logging onto iPledge, a national online database.
The new rules are meant to prevent isotretinoin-related birth defects once and for all. But the rules are so strict, some doctors say, they might discourage or even prevent many patients from using the drug, the only treatment that can erase severe acne. Many dermatologists say the iPledge program is overkill.
"It's one of the worst things that's happened to our specialty," said Dr. Ranella Hirsch, a Boston dermatologist who is the vice president of the American Society of Cosmetic Dermatology & Aesthetic Surgery. "We're taking a very good drug that is for many people the only real choice out of reasonable access."
Acne is the most common skin disease in the United States, affecting as many as 85 percent of people from 12 to 24 years old, according to the National Institutes of Health. Nearly 17 million people have it, most of them under 30.
Many acne sufferers are satisfied with simple, over-the-counter treatments like benzoyl peroxide cream. But isotretinoin has been the undisputed gold standard for extreme cases, and even for many moderate ones.
Roche, the maker of Accutane, estimates that nearly 7 million Americans have taken its drug. Hundreds of thousands more have taken other brands of isotretinoin since they came on the market after Roche's patent expired in 2002. "It is perhaps the most revolutionary drug in dermatology ever," said Dr. Lee Zane, the director of the Acne Specialty Practice at the University of California, San Francisco. "The number of people walking around with really severe scarring acne has diminished significantly with the advent of isotretinoin."
The most commonly reported side effects are dry skin and chapped lips, but the drug has also been linked to fatigue, severe joint pain, headache, upset stomach and blurred vision. Some suspect that isotretinoin may also cause depression or even suicide, although scientific studies have not demonstrated a connection.
But the importance of avoiding pregnancy is undisputed. Isotretinoin causes the most severe birth defects if an expectant mother takes it during her first trimester, when she is least likely to know she is pregnant.
Dr. Nancy Green, the medical director of the March of Dimes, which supports research and education to prevent birth defects, said: "We've been advocating since 2000 for FDA to take this kind of step. Is this the perfect solution? We'll have to wait and see." The new rules require that men who are prescribed isotretinoin, as well as women who have had hysterectomies or are otherwise unable to become pregnant, register with iPledge, though they are not required to use contraception or have pregnancy tests.
As of March 1, physicians and pharmacists will also be required to register each isotretinoin prescription with iPledge to verify that they have done their part to ensure against pregnancy.
Doctors say the new rules may force them to raise the price of treatment to cover the time and testing required. The drugs alone cost about $600 a month.

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