A patient taking isotretinoin (13-cis retinoic acid) for severe acne becomes pregnant. What is the risk?
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A
Highly teratogenic — causes craniofacial, cardiac, and CNS defects; strict pregnancy prevention required (iPLEDGE program equivalent in Saudi Arabia)
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B
Isotretinoin is safe in pregnancy after the first trimester
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C
Teratogenicity is theoretical — pregnancy outcomes are normal in clinical experience
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D
Only category B teratogenic risk — requires monitoring but no pregnancy prevention