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Стоит ли избегать sulindac при беременности? | VeriMom

Sulindac is an NSAID with human and animal evidence of fetal harm (e.g., fetal renal dysfunction/oligohydramnios and ductus arteriosus effects that are class warnings for NSAIDs) and is listed by some safety sources as suspected/known developmental hazard; therefore reproductive hazard is suspected (H361 level evidence from registrants/SDSs and clinical reports). Mechanism is demonstrated COX/prostaglandin inhibition with known placental/fetal effects. Topical cosmetic use would give negligible systemic exposure compared with oral dosing; therefore exposure from a cosmetic topical route is judged negligible for adults. (Sources: LactMed (NLM), StatPearls/NCBI review of NSAIDs in pregnancy, clinical/toxicology studies; SDSs listing H361).

ECHA regulatory hazard statements

  • H360
  • H361

What to use instead

Pregnancy-safe ingredients that serve a similar function:

FAQ

Безопасен ли sulindac при беременности?
Sulindac is an NSAID with human and animal evidence of fetal harm (e.g., fetal renal dysfunction/oligohydramnios and ductus arteriosus effects that are class warnings for NSAIDs) and is listed by some safety sources as suspected/known developmental hazard; therefore reproductive hazard is suspected (H361 level evidence from registrants/SDSs and clinical reports). Mechanism is demonstrated COX/prostaglandin inhibition with known placental/fetal effects. Topical cosmetic use would give negligible systemic exposure compared with oral dosing; therefore exposure from a cosmetic topical route is judged negligible for adults. (Sources: LactMed (NLM), StatPearls/NCBI review of NSAIDs in pregnancy, clinical/toxicology studies; SDSs listing H361).
Безопасен ли sulindac при грудном вскармливании?
Breastfeeding guidance (LactMed) advises avoidance or preference for alternatives because data are lacking and sulindac has a long half‑life and metabolites; systemic maternal exposure can transfer drug/metabolites to milk. Mechanism (COX inhibition/systemic distribution) is established. Topical cosmetic use would be expected to give negligible maternal systemic exposure, so direct exposure via milk from cosmetic use is expected to be negligible. (Sources: LactMed, NCBI reviews, SDSs).
Безопасен ли sulindac для кожи малыша?
No infant‑specific dermal toxicity data were found. Hazard and mechanism remain the same (suspected reproductive/developmental hazard via prostaglandin inhibition). For baby skin (0–3 yr) exposure score is increased by +1 relative to adult because infant skin barrier is immature and systemic absorption may be greater if measurable; although topical cosmetic use of sulindac is uncommon and absolute absorption is likely low, infant exposure via dermal application cannot be assumed negligible without formulation data. (Sources: LactMed, NCBI/StatPearls on NSAIDs; SDSs/EHS listings).
Как VeriMom оценивает sulindac?
VeriMom оценивает sulindac в 27/100 (высокий риск) на основе EU CosIng, классификаций ECHA и исследований PubMed.
Какие безопасные альтернативы sulindac при беременности?
См. наш список безопасных альтернатив sulindac с аналогичной функцией и классификацией без известных рисков.

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Медицинская оговорка

Данная информация предоставлена исключительно в образовательных целях и не является медицинской рекомендацией. Оценки безопасности основаны на общедоступных данных и могут не отражать все риски. Всегда консультируйтесь с вашим врачом перед использованием любых средств во время беременности или грудного вскармливания.

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