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Investigators from multiple institutions conducted a retrospective analysis of reports made to the US Food and Drug Administration (FDA) to assess the rates of pregnancy-related adverse events associated with isotretinoin use before and after the 2006 implementation of the iPLEDGE program. iPLEDGE was meant to reduce fetal exposure to isotretinoin by requiring female patients of childbearing potential to have a negative pregnancy test and verify 2 forms of contraception monthly to obtain an isotretinoin prescription. iPLEDGE also requires prescribers to report to the FDA any pregnancies among isotretinoin users.
Investigators used the FDA …
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