Preventing Isotretinoin-Related Birth Defects: Rules Too Harsh?
January 16, 2006
Preventing Isotretinoin-Related Birth Defects: Are the Rules Too Harsh?
Acne problems? If you're a woman and want a solution, you may have to take a pregnancy test - every month.
As of 2006, the US Food and Drug Administration (FDA), together with companies that make acne-treatment isotretinoin, has imposed strict mandatory prescribing rules, according to a report in the New York Times online on January 12, 2006.
Isotretinoin, available since 1982 and is sold under brand names Accutane, Amnesteem, Claravis and Sotret, can cause severe birth defects. A previous voluntary program designed to prevent women on isotretinoin from getting pregnant failed in 2-3 out of 1,000 women, according to a survey of almost 450,000 patients conducted at Boston University in 1989-2003.
Acne Facts
The most common skin disease in the US, acne affects an estimated 17 million people of all races and ages, although adolescents and young adults are more likely to have it. Nearly 85% of people aged 12-24 years are affected by acne, according to the National Institutes of Health. While the condition tends to disappear by the time people reach age 30 years, it persists in some people into their 40s and 50s.
Although over-the-counter medications such as benzoyl peroxide cream may offer some relief, isotretinoin continues to be the preferred treatment -particularly in extreme cases of the disease. In fact, isotretinoin is the only available effective treatment for severe acne.
Isotretinoin has been approved for severe acne, but doctors often prescribe it off-label to treat milder cases.
The New Rules
As of 2006, new FDA rules require that women of childbearing age who receive isotretinoin:
- must have negative pregnancy tests for two months in a row, before starting treatment with isotretinoin;
- while taking isotretinoin, either use two types of contraception, or provide a written promise that she will abstain from sex with a man. If she chooses the former, one of the forms of birth control must be a highly effective kind, such as birth control pills or Depo-Provera;
- during treatment, which usually lasts five months, take a monthly pregnancy test;
- document her relevant behavior online at iPledge, a national online database.
Are the Rules Too Strict?
The new FDA rules are designed to prevent isotretinoin-related birth defects. However, some doctors believe that the rules are excessive and might discourage or prevent patients from using isotretinoin.
"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, according to the New York Times. "We're taking a very good drug that is for many people the only real choice out of reasonable access."
Roche, who manufacture Accutane, estimates that nearly seven million Americans have taken the drug, according to the New York Times. Additionally, hundreds of thousands more people have received treatment with other brands of isotretinoin since 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 Risks Involved
Unquestionably, to avoid pregnancy while taking isotretinoin is highly desirable. The drug causes the most severe birth defects during the first trimester, when a woman is least likely to know she is pregnant.
"There's something that's known as Accutane embryopathy," said Margaret Honein, an epidemiologist at the National Center on Birth Defects and Developmental Disabilities, according to the New York Times. Exposed fetuses "often have a pattern of several major malformations" that may affect the head, eyes, ears, face, heart and brain.
Despite these risks, some doctors believe that the rare occurrence of pregnancy in women taking isotretinoin should not affect drug access for the millions of people who get acne. "If the use of Accutane goes down 75 percent, in my mind, the program will be a failure, because there will be tens of thousands of people who will have been hurt," said Dr. Noah Scheinfeld, a dermatologist at St. Luke's-Roosevelt Hospital Center in Manhattan, according to the New York Times. Dr Scheinfeld advocates returning to a voluntary pregnancy-prevention program.
Another risk of the strict new rules is that they may cause some patients to purchase isotretinoin from foreign sources, thereby entirely missing physician supervision and appropriate education about the risks of pregnancy and importance of avoiding it while on the medication.
However, of equal concern to dermatologists is the possibility that, if a few pregnancies still occur, the FDA may ban isotretinoin. Dr Zane of the University of California reportedly said, "[This] will send us back essentially to the dark ages of acne treatment, where there will be many, many, many people walking around with severe, scarring, debilitating and psychologically-devastating acne."
Sources:
Doctors Fear Acne Drug Rules Go Too Far, The New York Times,
January 12, 2006.
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and Answers About Acne, National Institutes of Health
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