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Isotretinoin must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that isotretinoin will cause loss of the pregnancy, or will cause the baby to be born too early, to die shortly after birth, or to be born with birth defects physical problems that are present at birth.



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The acne drug Accutane is one of the most dangerous products on the market today. The drug causes serious side-effects, most notably birth defects. This combination—unique efficacy coupled with unique risk—has posed a serious challenge for the Food and Drug Administration FDA. Over the past two decades, FDA has grappled with how manage the completely preventable but persistently serious problem of Accutane-induced birth defects. On several occasions, the product spurred FDA to take unprecedented regulatory action. In when American researchers for Hoffmann-La Roche began studying the chemical, isotretinoin, they were struck by its remarkable effectiveness.


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