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US government health experts on 17th August 2001, renewed warnings to
women not to take the acne medication Accutane during pregnancy because
the drug could cause devastating birth defects in newborns.
The Centers for Disease Control and Prevention said there were more than
2,000 reports of pregnancies exposed to Accutane between 1982 and March
last year.
Accutane is prescribed to treat severe acne. When taken by pregnant women,
it can cause brain, heart and facial defects in fetuses, and some babies
exposed to the drug while in the womb have been born without ears.
The Atlanta-based CDC said confusion over a symbol intended to remind
women not to get pregnant while taking Accutane and other medications
appeared to be at least partly responsible for some cases of exposure
to the drug.
Prescriptions that are not meant to be taken during pregnancy are usually
labelled with a symbol showing a pregnant woman in a circle with a slash
through it.
But a study published in the September issue of the journal Teratology
showed that one-third of women surveyed apparently confused medications
with birth control when they saw such symbols.
The CDC advised women who could be or could become pregnant to have two
negative pregnancy tests before taking Accutane.
While taking the drug, women should use two forms of birth control, have
monthly pregnancy tests and register for monitoring, the CDC said.
“Health-care providers must counsel their patients to ensure that
these recommendations are followed to prevent these serious and completely
preventable birth defects,” said Dr Jose Cordero, acting director
of the CDC’s National Center on Birth Defects and Developmental Disabilities.
Since 1988, the CDC and the Food and Drug Administration have worked together
to educate doctors and women of reproductive age of the potential dangers
of taking Accutane during pregnancy.
The FDA and Hoffman-LaRoche, the manufacturer of Accutane, are finalizing
an enhanced risk management program for the medication. Hoffman-LaRoche
is a unit of Roche Holding.
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