Acetylsalicylic acid
Regulatory sources consulted
- AEMPS CIMA FT_42991
- PubMed PMID:39174149 ↗
- PubMed PMID:37019801 ↗
- Clinical Pharmacist Knowledge
- AEMPS CIMA · nº registro 42991 ↗
- RxNorm rxcui 198471 ↗
Approved indications
- Secondary prevention of myocardial infarction, ischemic stroke, and other cardiovascular events in high-risk patients (e.g., stable angina, history of TIA).
- Management of obstetric antiphospholipid syndrome to prevent pregnancy complications, usually in combination with low-molecular weight heparin. · off-label
Contraindications
Absolute
- Hypersensitivity to salicylates or NSAIDs, active peptic ulcer, bleeding diathesis, severe renal/hepatic/cardiac failure, third trimester of pregnancy.
- Concomitant use with methotrexate at doses ≥ 15 mg/week.
Clinical warnings
- Major warning · Risk of gastrointestinal bleeding. Use with caution in patients with a history of ulcers or bleeding disorders. — AEMPS CIMA
- Major warning · Reye's Syndrome: Should not be given to children or adolescents with viral infections (chickenpox, flu) due to the risk of developing Reye's syndrome. — AEMPS CIMA
Drug interactions
- HighMethotrexateL01BA01
Mechanism: Decreased renal clearance of methotrexate, increasing its hematological toxicity.
Recommendation: Contraindicated with methotrexate doses ≥ 15 mg/week. Monitor closely with lower doses.
AEMPS CIMA
- ModerateIbuprofenM01AE01
Mechanism: Ibuprofen may antagonize the irreversible antiplatelet effect of low-dose aspirin, limiting its cardioprotective benefit.
Recommendation: If ibuprofen use is required, administer it at least 30 minutes after or >8 hours before immediate-release aspirin.
AEMPS CIMA
Adverse events
Common (≥1%)
dyspepsia · gastrointestinal pain · increased bleeding time · epistaxis · gingival bleeding
Rare but serious
severe gastrointestinal bleeding · intracranial hemorrhage · Reye's syndrome · anaphylactic reactions · thrombocytopenia
Pregnancy and lactation
FDA category: D (3rd trimester: X)
Contraindicated in the 3rd trimester. Low doses (75-100 mg) are used under medical supervision for specific indications like pre-eclampsia prevention or in antiphospholipid syndrome. High doses can cause fetal toxicity. Lactation: With low doses (75-325 mg/day), salicylate levels in milk are low; monitor infant for bruising or bleeding. Avoid continuous high doses.
Recent literature (PubMed)
Revisión sobre el síndrome antifosfolípido obstétrico que destaca la aspirina a dosis bajas, a menudo con heparina, como la base del tratamiento para prevenir complicaciones. También aborda la seguridad de la aspirina a dosis bajas durante la lactancia, señalando que los niveles en leche materna son bajos.
Revisión narrativa que explora el uso de estatinas y aspirina en infecciones parasitarias. Concluye que, si bien las estatinas pueden ser un adyuvante factible, no hay evidencia experimental sólida para el uso de aspirina en este contexto, y se necesitan más estudios.