Is aceclofenac (a nonsteroidal anti-inflammatory drug (NSAID)) contraindicated during pregnancy?

Aceclofenac is Contraindicated During Pregnancy

Aceclofenac, like other NSAIDs, is contraindicated during pregnancy, especially in the third trimester, due to significant risks to fetal development and pregnancy outcomes. 1

Risks of NSAIDs in Pregnancy

First and Second Trimester

• While early pregnancy exposure to NSAIDs shows no clear evidence of increased risk of miscarriage or teratogenicity, data specifically for aceclofenac is limited 1
• Most reassuring data exists for ibuprofen and diclofenac, but even these should be used cautiously 1
• Even in the second trimester, NSAIDs should only be used short-term (7-10 days) at the lowest effective dose 1
• Long-term use of NSAIDs (including diclofenac, which is structurally similar to aceclofenac) even before gestational week 28 can cause early-onset oligohydramnios 2

Third Trimester (After Week 28)

• NSAIDs are absolutely contraindicated after gestational week 28 due to:
  • Premature closure of the ductus arteriosus 1, 3
  • Oligohydramnios 3, 2
  • Fetal renal injury 3
  • Risk of persistent pulmonary hypertension in the newborn 3
  • Necrotizing enterocolitis 3
  • Intracranial hemorrhage 3

Fertility Considerations

• NSAIDs can interfere with ovulation as this process depends on prostaglandins 1
• Continuous periovulatory exposure can induce luteinized unruptured follicle syndrome, reducing fertility 1
• Women having difficulty conceiving should consider discontinuing NSAIDs 1

Alternative Medications in Pregnancy

For pain management during pregnancy, consider:

• Acetaminophen (paracetamol) - generally considered safe during pregnancy 4
• If anti-inflammatory treatment is absolutely necessary:
  • Prednisone/prednisolone at the lowest effective dose (ideally ≤5 mg/day) 1
  • For severe, refractory conditions, consult with specialists for pregnancy-compatible alternatives 1

Important Caveats and Recommendations

• Despite contraindications, studies show approximately 3% of women still use NSAIDs close to delivery 5
• About 6% of prescriptions to pregnant women contain drugs that are not recommended, and 1% contain drugs that are contraindicated 6
• Many women are unaware of the risks associated with NSAID use during pregnancy 5
• Patient education about avoiding over-the-counter NSAIDs is crucial, as many women may not realize these medications are contraindicated

Conclusion

Aceclofenac should be avoided throughout pregnancy, with absolute contraindication after gestational week 28. The risks to fetal development and pregnancy outcomes outweigh potential benefits, especially when safer alternatives are available.