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FDA Tightens Restrictions on Accutane

Tougher controls on prescription acne drug aimed at reducing pregnancy risks

FRIDAY, Nov. 2, 2001 (HealthDayNews) -- Women taking the acne drug Accutane soon will face tough new restrictions meant to ensure they don't become pregnant while taking the medication.

Severe birth defects and even fetal death have been linked to Accutane, known generically as isotretinoin, a drug approved to treat the most serious forms of acne.

For several years, regulations have required that a woman test negative for pregnancy twice before a doctor can prescribe a course of Accutane, and pregnancy tests must remain negative while she takes the drug. Women also must agree to use two separate forms of effective birth control -- such as condoms, oral contraceptives or sterilization -- from a month before they start taking Accutane until a month after they finish their treatment. And, they must sign several forms acknowledging information about side effects.

But this week, in response to concerns that pregnancies still are occurring among women taking Accutane, the Food and Drug Administration added a new layer of rules. When they take effect early next year:

  • A doctor will have to apply a special yellow sticker to all Accutane prescriptions, verifying that the woman has met the FDA's non-pregnancy requirements for taking the drug.
  • Pharmacists no longer can accept phone or electronic prescriptions or refill orders for Accutane. Only paper prescriptions with the required sticker will be accepted.
  • All prescriptions must be filled within seven days of the date on the sticker.
  • Pharmacists no longer will be allowed to dispense the traditional six-month course of Accutane. They can provide only a one-month supply at a time.
  • A medication guide about Accutane must be given out with every prescription.

The new regulations will become part of the pregnancy prevention program established 13 years ago by Hoffmann-La Roche, the New Jersey-based maker of Accutane. The company created the program after the drug was linked to fetal face, heart and brain deformities so severe that many doctors recommend abortions to women if they conceive while taking the drug.

"The pregnancy tests are not new," says company spokeswoman Gail Safian. "We've had those for years."

What's new, she says, is the "Accutane Qualification Sticker" that doctors wishing to prescribe the drug will need to start using.

Dr. Sancy Leachman, an assistant professor of dermatology at the University of Utah Health Sciences Center in Salt Lake City, says the stiffer regulations on prescribing Accutane stem from the fact that "it is a teratogenic drug," meaning one that can cause malformation of a fetus.

"It never hurts to put an extra precaution in place," she says.

But Leachman, who stresses she has no relationship with the manufacturer, says people also should remember that Accutane is not the only widely used drug with the potential to cause birth defects. And, although proper precautions are necessary, she says, the medication can be incredibly effective in treating severe acne that hasn't responded to other treatments.

"People who have this really, really bad acne, their whole self-image and the whole way that they view life is different if they get Accutane," Leachman says.

Safian says that Hoffmann-La Roche has been working with the FDA for years to minimize the number of pregnancies among women taking Accutane.

"The pregnancy rate among Accutane patients is significantly lower than the pregnancy rate in the general population," she says. "We do know that at least 97 percent of dermatologists who prescribe Accutane use the materials that we've had in place already."

Studies conducted by the drug company, she says, found that young men, young women and parents understand that the graphics on Accutane packaging mean the drug should not be taken during pregnancy. The graphic features a red circle with a slash superimposed over a silhouette of a pregnant woman.

However, an independent study published earlier this fall, which surveyed a small group of women of childbearing age, says that more than 25 percent of them interpreted the graphic as meaning that Accutane was a form of birth control.

Leachman says that, although it may be difficult to understand how such graphics are misunderstood, it underscores how important counseling from doctors and other medical professionals can be. She says she frequently shows younger patients taking Accutane an instructional video about the drug's risks.

The new regulations will take effect early next year, Safian says, after doctors have a chance to enroll in the program and obtain the needed stickers. Hoffmann-La Roche now is finalizing letters and brochures for patients, physicians and pharmacists and plans to distribute them by Jan. 2, she says.

"Our goal is to find ways to document that female patients are not pregnant when they start taking Accutane, and they do not become pregnant when they're on the medication," Safian says.

What To Do

Find out more about Accutane from Hoffmann-La Roche, RxList, American Family Physician or the FDA.

SOURCES: Interviews with Sancy A. Leachman, M.D., Ph.D., assistant professor, Department of Dermatology, Huntsman Cancer Institute, University of Utah Health Sciences Center, Salt Lake City; Gail Safian, spokeswoman, Hoffmann-La Roche, Nutley, N.J.
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