Accutane Acne drug
Stricter rules explained
Aug 25, 2005 - Users and dispensers of Accutane acne drug must now register with the government as a way to prevent birth defects the drug causes.
If a woman becomes pregnant while taking Accutane, the fetus can die or the baby can be born with retardation or brain and heart deformities. The Food and Drug Administration reports that since Accutane hit the market in 1982, more than 2,000 women taking the drug have become pregnant, a figure considered largely underreported.
Starting Dec. 31, 2005, patients, doctors and pharmacists must enroll in the iPLEDGE computerized registry to receive Accutane or its generic competitors, the FDA announced this month. Users of the accutane acne drug must sign a document informing them of the drugs risks.
The FDA requires women of child-bearing age to take additional steps, including submitting to two pregnancy tests in a laboratory or doctor's office before the initial prescription is filled and monthly pregnancy tests before each refill. They also must be using two forms of birth control. The doctor must enter the results of the pregnancy test into the iPLEDGE system.
The FDA first attempted to tighten Accutane acne drug access in 2001 with many of the same procedures under the SMART program (System to Manage Accutane Related Teratogenicity). The restrictions were largely voluntary and were not uniformly applied.
Bill Halmi, a Phoenix dermatologist, answers some questions about accutane acne drug and its use:
Question: What is Accutane used to treat?
Answer: Primarily, severe acne. The standard of care is that you try other acne treatments first.
Q: How long does someone take Accutane?
A: Five months. People use it, and their acne is gone for life.
Q: How effective is Accutane?
A: Eighty-five percent of people who use it, never get (acne) back. It's an amazing drug.
Q: Can you explain how it works in simple terms?
A: It prevents the clogging of pores in a permanent manner.
Q: Will the new restrictions impact the number of Accutane prescriptions you write?
A: We've already gone through a lot of hoops to prescribe Accutane. There will be no more level of hassle in prescribing the drug. It won't alter the number of prescriptions.
Q: Have patients asked about the restrictions or expressed concern?
A: No. That probably won't happen for a few more months.
Q: Will the restrictions work in preventing fetal death and birth defects?
A: The vast majority of women who got pregnant on Accutane had done everything properly. The SMART system did not make a significant change in pregnancy issues. Patients, and not many, are just making bad choices, and we'll never be able to control that.
Q: Restrictions on Accutane have gotten progressively tighter over the past two decades. What if it were just eliminated as an option?
A: It is the most effective tool in fighting acne. I can tell you dermatologists would think it would be terrible. People who had scarring cystic acne would be permanently scarred for life.
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