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Panel Seeks Tough Restrictions on Acne Drug

FDA committee recommends national registry for Accutane

FRIDAY, Feb. 27, 2004 (HealthDayNews) -- An advisory committee on Friday recommended that the federal government establish a national registry to help prevent pregnancy among women who are using the acne drug Accutane.

Even small doses of Accutane and its generic equivalent, isotretinoin, are known to cause birth defects, including brain and heart damage, mental retardation and other abnormalities such as cleft lip and palate. The risk is still present for about a month after discontinuing use of the drug.

"We've known it's an issue for many years," says Dr. Marsha Gordon, associate clinical professor of dermatology at the Mount Sinai School of Medicine in New York City. "Accutane is not the only medicine that can't be taken during pregnancy. A lot of precautions are in place."

Since 1982, when the drug was first introduced, the U.S. Food and Drug Administration has had more than 2,000 reports of women becoming pregnant while taking the drug. Most had an abortion, some gave birth to healthy babies but more than 160 babies were born with Accutane-related defects. Dr. Nancy S. Green, medical director of the March of Dimes, said in a statement that she feared the 2,000 figure "may be only the tip of the iceberg."

The FDA instituted a voluntary testing and contraceptive education program in 2001 for patients considering Accutane.

The strategy apparently failed to reduce the number of pregnancies among women taking the drug, however. In the first year, there were 120 pregnancies recorded, almost the same as the previous year even while the number of prescriptions dropped.

"Major birth defects caused by exposure to Accutane and other brands of isotretinoin... continue to occur in the United States each year because of the failure of voluntary safety measures meant to prevent them," read a statement from the March of Dimes.

The March of Dimes has been lobbying the FDA to impose more stringent restrictions on Accutane and isotretinoin modeled on the national registry system currently being used for thalidomide. Thalidomide was a morning sickness drug prescribed heavily until it was taken off the market for causing birth defects. But in recent years, it was found to help people with leprosy and HIV, and it was brought back under strict control.

The FDA advisory committee met Thursday and Friday to discuss the issue. At the end of the day Friday, the committee voted 16-8 for a registry system that would disallow women from getting their monthly supply of the medication without a negative pregnancy test. Women will also be directed to use not one but two forms of contraception while on Accutane, according to the Associated Press. Men also will be registered to discourage them from sharing prescriptions with women.

Any health worker who prescribes Accutane and any drugstore that dispenses it must also be signed up.

According to the AP, Hoffman-La Roche, the pharmaceutical company that makes Accutane, as well as makers of the generic version, are in favor of a registry.

Although the FDA is not bound to follow any committee's recommendations, it generally does so.

FDA officials have pointed out that even a registry will not eliminate pregnancies among Accutane users altogether.

There has also been concern that Accutane might contribute to depression and suicidality. "We are told that we need to discuss this with our patients and if they have a history of depression, that this may not be the medicine for them,"' Gordon says.

For its stated purpose, however, Accutane is legend. "It really works. We have this wonderful drug that cures acne in 80 to 90 percent of the people who take it and prevents a lifelong disfigurement," Gordon says. "I agree it's a serious medication with a lot of things you have to be careful about, but a lifetime of facial scarring is a hard way to go."

More information

For more on acne, visit or the American Academy of Dermatology. Meanwhile, the University of Iowa has more on Accutane.

SOURCES: Marsha Gordon, M.D., associate clinical professor of dermatology, Mount Sinai School of Medicine, New York; Associated Press; March of Dimes statement
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