Government scientists will ask the Food and Drug Administration to consider withdrawing the popular acne-fighting drug Accutane from the market because pregnant wom-en continue to take it even though it causes birth defects, the scientists said Friday.
Further restrictions on distribution of the drug, rather than complete withdrawal, are another measure that will be recommended for consideration, said Dr. David Ericson, chief of the birth defects and genetic diseases branch of the Centers for Disease Control in Atlanta.Ericson and other scientists as well as manufacturers' representatives will make their recommendations on the orally taken drug Tuesday at a meeting of a FDA advisory panel.
In a confidential memo, FDA officials estimated that between 900 and 1,300 babies were born with "severe birth defects" because of the drug from 1982 to 1986, according to The New York Times.
"I don't know personally that we really know the magnitude of the problem," Ericson said in a telephone interview. "We do know there have been babies born with birth defects because of this drug. There's a problem and we need to do something new to prevent them (the defects)."
The drug, whose generic name is isotretinoin, has been on the market since September 1982 for the treatment of severe acne. It is made by Roche Laboratories, a division of Hoffman-La Roche Inc. A Roche spokeswoman, Carolyn Glynn, said one million patients had taken the drug and half of them were women.
The drug packaging bears clear warnings, and the company has conducted information campaigns to alert consumers that the drug can cause devastating and sometimes fatal deformities if taken by pregnant women.
In addition to birth defects, the Times said the internal FDA memo attributed 700 to 1,000 spontaneous abortions to the use of Accutane, and estimated that another 5,000 to 7,000 women had induced abortions "solely because of Accutane exposure and fear of birth defects."
"I don't think we have an accurate figure on the number of babies (with birth defects) and all," said FDA spokesman Don McLearn.
McLearn said a major concern of the agency was that the drug was being over-prescribed.
"The number of people that have severe acne that would require this drug is too small to account for all the prescriptions being written," he said.
A difficulty is that some younger women for whom the drug is prescribed may not want to admit they're having sex and may be vulnerable to pregnancy, McLearn said.
However, he and Ericson pointed out the drug is valuable and one of the only ones that works on severe acne.