U.S. Reportedly Weighs Limit on Anti-Acne Drug
NEW YORK — Government officials are considering removing a popular anti-acne drug from the market because they estimate it has caused more than 900 babies to be born with severe birth defects, it was reported today.
The officials, quoted in today’s editions of the New York Times, said that they also are considering asking the maker of Accutane, Roche Laboratories, a division of Hoffman-La Roche Inc., t1864395881drug is used against disfiguring acne.
A spokeswoman for the manufacturer disputed the government figures, saying it has reports of 62 cases of Accutane-related birth defects among the 700,000 to 1 million patients with cystic acne for whom the drug has been prescribed.
Despite clear warnings that the drug can cause devastating and sometimes fatal deformities if taken by pregnant women, experts estimate thousands have taken Accutane during pregnancy since it came on the market in 1982, according to the newspaper.
In a confidential memorandum dated Feb. 11 and obtained Thursday by the Times, officials of the Food and Drug Administration estimated that 900 to 1,300 babies were born with severe birth defects because of the drug from 1982 to 1986.
They also attributed 700 to 1,000 spontaneous abortions to the use of Accutane, and they estimated that an additional 5,000 to 7,000 women had induced abortions “solely because of Accutane exposure and fear of birth defects,†the newspaper reported.
Carolyn Glynn, spokeswoman for Hoffman-LaRoche in Nutley, N.J., said the company would meet with the FDA on Tuesday to discuss ways to better educate the public, doctors and pharmacists about the dangerous, and often fatal side effects.
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