In the pharmaceutical industry, Aceclofenac is a phenylacetic acid derivative within the Non-Steroidal Anti-Inflammatory Drug (NSAID) class. As a pharmacist and manufacturer, I classify this as a high-risk medication during pregnancy, particularly during the third trimester.
The safety profile of Aceclofenac is categorized by potential fetal toxicity and interference with the physiological process of labor.
Safety Profile by Trimester
| Pregnancy Stage | Safety Status | Clinical Risk |
| First Trimester | Avoid / Not Recommended | Possible increased risk of miscarriage and congenital malformations (heart/abdominal wall). |
| Second Trimester | Use only if Essential | Use at the lowest effective dose for the shortest duration if benefits outweigh risks. |
| Third Trimester | Strictly Contraindicated | High risk of premature closure of the fetal ductus arteriosus and renal dysfunction. |
Mechanism of Action & Fetal Risk
Aceclofenac works by inhibiting the enzymes COX-1 and COX-2, which stops the production of Prostaglandins. While this reduces pain for the mother, it can be dangerous for the fetus.
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Closure of Ductus Arteriosus: In the womb, the ductus arteriosus must remain open to allow blood to bypass the fetal lungs. Prostaglandins keep this vessel open. By blocking them, Aceclofenac can cause the vessel to close prematurely, leading to fetal pulmonary hypertension.
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Renal Impairment & Oligohydramnios: Aceclofenac can affect fetal kidney function, leading to a decrease in the production of amniotic fluid (the “water” surrounding the baby), a condition known as oligohydramnios.
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Labor Complications: Prostaglandins are essential for initiating labor. Inhibiting them can lead to delayed or prolonged labor and increased bleeding risk for both mother and child.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your WHO-GMP facility in Mumbai, ensuring clear safety labeling is a critical regulatory requirement:
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Marketing Accuracy: When listing Aceclofenac 100 mg tablets on your digital platforms, the “Contraindications” section must explicitly state “Pregnancy” (especially late-stage). This demonstrates your firm’s commitment to international safety standards like those set by the EMA and CDSCO.
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Alternative Recommendations: For clients inquiring about pain management during pregnancy, you might suggest Paracetamol, which remains the first-line, safer alternative for analgesia in pregnant populations.
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Dossier Support: We ensure that our Product Information Leaflets (PIL) and Summary of Product Characteristics (SmPC) contain updated safety warnings regarding female fertility and pregnancy, which is essential for successful product registration in regulated markets.
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Packaging Compliance: For export to regions with strict pharmacovigilance (like the EU or Middle East), clear “Not for use in pregnancy” icons on the outer carton can be a significant USP.