Folic Acid
Regulatory sources consulted
Approved indications
- Prevention and treatment of folic acid deficiency states: megaloblastic anemia, in childhood, pregnancy, malabsorption syndrome.
- Prevention of neural tube defects in the fetus in women with a history of a child or fetus with these alterations.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Untreated megaloblastic anemia due to Vitamin B12 deficiency, as it can mask neurological symptoms.
Clinical warnings
- Major warning · Folic acid treatment can mask vitamin B12 deficiency, which can allow the progression of irreversible neurological damage. B12 deficiency must be ruled out before starting treatment for megaloblastic anemia. — AEMPS CIMA
Drug interactions
- ModeratePhenytoinN03AB02
Mechanism: Folic acid may increase the metabolism of phenytoin, decreasing its plasma concentrations and seizure control. In turn, antiepileptics can decrease folate levels.
Recommendation: Monitor phenytoin levels and adjust the dose if necessary. Consider monitoring folate levels in patients on chronic antiepileptic treatment.
AEMPS CIMA
- HighMethotrexateL01BA01
Mechanism: Folic acid is a pharmacodynamic antagonist of methotrexate (a dihydrofolate reductase inhibitor). It can reduce the antineoplastic efficacy of methotrexate.
Recommendation: Avoid concomitant administration of folic acid with methotrexate in oncological indications. In rheumatoid arthritis, folic acid is administered to reduce methotrexate toxicity, but on different days.
AEMPS CIMA
Adverse events
Common (≥1%)
anorexia · nausea · abdominal distension · flatulence
Rare but serious
anaphylactic reaction · bronchospasm
Pregnancy and lactation
FDA category: A
Indicated for the prevention of neural tube defects during pregnancy. Folic acid is excreted in breast milk, but no adverse effects have been observed in infants. Its use is compatible with lactation.
Recent literature (PubMed)
Revisión que destaca la relación entre el estado nutricional y la pérdida auditiva, sugiriendo que las estrategias de intervención nutricional, que podrían incluir la suplementación con folatos, son necesarias para promover la salud auditiva. La etiología es multifactorial.
Metaanálisis en red de ECA que evalúa el efecto de antioxidantes dietéticos en el riesgo de cáncer de próstata. El ácido fólico mostró el menor efecto protector entre los agentes estudiados, siendo superado significativamente por las catequinas del té verde.