{"id":"1714be80-cb26-53f9-938b-c5668b38956e","stable_key":"6660bba2-4fa0-590a-bf52-9803a24bea9f:pregnancy-warning","predicate":"reported_relationship","statement":"Regulatory pregnancy concerns and contraceptive precautions are based on safety assessments, not proof of a specific arousal-circuit teratogenic mechanism.","claim_class":"observational","status":"source_recorded","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"d4a9bfc0-afde-5a94-8494-521a5b2c77b9","mechanism_event_label":"Regulatory pregnancy concerns and contraceptive precautions are based on safety assessments, not proof of a specific arousal-circuit teratogenic mechanism.","subject":{"id":"624e6a4b-f96d-5d12-8206-30d1e1715c26","slug":"modafinil","display_name":"Modafinil","entity_type_key":"drug"},"object":{"id":"d9d4e7a2-0bba-5b04-9013-bf1ebcd5005f","slug":"human-modafinil-pregnancy-risk","display_name":"Human modafinil pregnancy-risk observations and precautions","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"d4a9bfc0-afde-5a94-8494-521a5b2c77b9","stable_key":"6660bba2-4fa0-590a-bf52-9803a24bea9f:pregnancy-warning-event","event_type":"experimental_observation","label":"Regulatory pregnancy concerns and contraceptive precautions are based on safety assessments, not proof of a specific arousal-circuit teratogenic mechanism.","description":"Psychiatric, cardiovascular and pregnancy concerns need their own safety records. A proposed circuit mechanism cannot rule them out. Pregnancy risk assessments should distinguish observed associations, uncertainty and precautionary recommendations. [Regulatory safety assessment](https://www.gov.uk/drug-safety-update/modafinil-provigil-now-restricted-to-narcolepsy), [pregnancy advice](https://www.gov.uk/drug-safety-update/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy)","status":"provisional","compartment":null,"participants":[{"entity":{"id":"624e6a4b-f96d-5d12-8206-30d1e1715c26","slug":"modafinil","display_name":"Modafinil","entity_type_key":"drug"},"role":"tested factor","stoichiometry":null,"state_label":"as reported","sequence_order":0,"notes":""},{"entity":{"id":"d9d4e7a2-0bba-5b04-9013-bf1ebcd5005f","slug":"human-modafinil-pregnancy-risk","display_name":"Human modafinil pregnancy-risk observations and precautions","entity_type_key":"cellular_process"},"role":"measured outcome","stoichiometry":null,"state_label":"not_reported","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_access","value_text":"Official pregnancy and method-specific contraception guidance read; page dated 2020-11-16.\nOfficial safety guidance read; March 2011 article with subsequent pregnancy update. 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No clinical efficacy, nutrient deficiency or unique molecular mediation is inferred.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Regulatory pregnancy concerns and contraceptive precautions are based on safety assessments, not proof of a specific arousal-circuit teratogenic mechanism.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"MHRA modafinil pregnancy and contraception update | https://www.gov.uk/drug-safety-update/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"MHRA restricted indication and safety advice | https://www.gov.uk/drug-safety-update/modafinil-provigil-now-restricted-to-narcolepsy","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"source_locator","value_text":"Reviewed reference lines 168-168; exact primary location described in quoted passage where extracted.","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"4d65d6e2-91d6-5ad2-a86a-2ea8b42cd219","evidence_kind":"source_excerpt","locator":"Lines 168-168","start_line":168,"end_line":168,"excerpt":"Psychiatric, cardiovascular and pregnancy concerns need their own safety records. A proposed circuit mechanism cannot rule them out. Pregnancy risk assessments should distinguish observed associations, uncertainty and precautionary recommendations. [Regulatory safety assessment](https://www.gov.uk/drug-safety-update/modafinil-provigil-now-restricted-to-narcolepsy), [pregnancy advice](https://www.gov.uk/drug-safety-update/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy)","model_system":"Official regulatory safety guidance; precaution distinguished from measured mechanism.","directness":"reported_statement","verification_status":"source_recorded","notes":"Exact excerpt of the retained AI-assisted reviewed reference; primary sources are cited in primary_references and access scope is retained. Not a verbatim quotation from a primary paper.","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"17a64928-eaa2-5117-ba4f-52dcbdf9cc9e","stable_key":"import-6660bba2-4fa0-590a-bf52-9803a24bea9f","title":"Modafinil: detailed mechanisms of action (reviewed 3 October 2026)","document_type":"imported_text","citation_label":"Original AI-assisted review of primary studies and, where relevant, official regulatory records. Access level is retained per claim. Corrections, null results and unresolved questions remain explicit. Not publisher full text or independent replication.","file_path":"","sha256":"006008cb4cfd183dd3b0846d3abc66c8ebf40cf1b6bd1f0bcdb4f4d937a8e115","revision_id":"c85b3e2e-c18a-59fc-9e79-5c375e64d119","review_status":"source_recorded","notes":""}}],"relations":[],"conflicts":[],"corrections":[],"research":null}