May Be as Dangerous as Thalidomide, Researchers Say : Acne Drug, Severe Birth Defects Linked

Accutane, a drug used to treat severe acne, may be as dangerous to fetuses as thalidomide, a drug that caused a rash of birth defects in the early 1960s, researchers said Wednesday.

Pregnant women who use Accutane run a high risk of miscarrying or having children with severe defects, said Dr. Edward J. Lammer of the Massachusetts General Hospital Embryology-Teratology Unit.

“It would be a grave mistake to say there is a safe time (during pregnancy) to take the drug,” said Lammer, primary author of the study in the New England Journal of Medicine. “There aren’t that many drugs that have that strong of an effect.”

Used as Last Resort

Accutane, manufactured by Hoffmann-LaRoche Inc., has been distributed since 1982. It is a medication of last resort for those who suffer from severe acne. A typical course of therapy lasts four to five months.

The study of 154 pregnancies in women who took Accutane showed that a fetus had a 20% chance of suffering a severe birth defect, provided that it had developed long enough to be able to survive outside the womb. This is an “unusually high” risk, Lammer said.

A comparable risk resulted from exposure to thalidomide, which caused malformations in about 20% of exposed fetuses.

Intended as Sedative

However, thalidomide was intended for pregnant women as a sedative, so the number of fetuses exposed from 1959 to 1962 was enormous. Accutane was never intended to be taken by pregnant women.

Consequently, “as a public health problem, there is no comparison” between the adverse impact of the two drugs, Lammer said.

Hoffmann-LaRoche spokeswoman Carolyn Glynn said that the firm and the Food and Drug Administration have issued strong and repeated warnings to doctors, pharmacists and the public that the medication should not be used during pregnancy.