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FDAs Clinical Pharmacology team disagreed, concluding the reductions "could pose a clinically significant risk of loss of efficacy of contraception and unintended pregnancy" which is the basis for the backup-contraception guidance in ref

However, many families have been reported in literature and over 300 patients have been described

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Patients should never obtain these medications from unregulated sources or use them without proper medical supervision, as this significantly increases safety risks