Is Celestine (Celecoxib) injection safe to use during the second trimester of pregnancy?

Celecoxib Injection in Second Trimester: Safety Assessment

Direct Recommendation

Celecoxib should be avoided during the second trimester of pregnancy due to significant fetal risks, including premature closure of the ductus arteriosus and oligohydramnios, particularly after 20 weeks gestation. 1

Evidence-Based Rationale

FDA Drug Label Warnings

The FDA explicitly warns against celecoxib use in pregnancy with the following critical concerns:

• Premature closure of the fetal ductus arteriosus: NSAIDs, including celecoxib, should be avoided at approximately 30 weeks gestation and later because they can cause premature closure of the fetal ductus arteriosus 1

• Oligohydramnios and neonatal renal impairment: If celecoxib is necessary at about 20 weeks gestation or later, it must be limited to the lowest effective dose and shortest duration possible (ideally <48 hours) 1

• Monitoring requirements: If treatment extends beyond 48 hours, ultrasound monitoring for oligohydramnios is required, and the drug must be discontinued if oligohydramnios occurs 1

Clinical Guidelines on NSAIDs in Pregnancy

The 2025 EULAR recommendations provide clear guidance on NSAID use:

• NSAIDs can be used only during the second trimester for short duration (7-10 days maximum) at the lowest effective dose 2, 3

• NSAIDs should be discontinued after the 28th week of gestation due to increased fetal risks 3

• All NSAIDs are contraindicated in the third trimester 2, 3

Limited Research on Celecoxib-Specific Use

One pilot case series examined celecoxib use for preterm labor in the second trimester, showing that administration for more than 48 hours might be tolerable with careful ultrasound monitoring of ductus arteriosus peak systolic velocity and amniotic fluid volume 4. However, this study:

• Involved only 15 patients 4
• Required intensive fetal monitoring 4
• Documented three cases where ductus arteriosus velocity exceeded the 95th percentile, requiring dose reduction or discontinuation 4
• Was conducted specifically for tocolysis when conventional agents failed, not for routine pain management 4

Animal Data Concerns

Celecoxib caused significant developmental toxicity in animal studies:

• Ventricular septal defects in rabbits at doses ≥150 mg/kg/day (approximately 4 times the maximum human dose) 1
• Diaphragmatic hernias in rats at doses ≥30 mg/kg/day (approximately 13 times the maximum human dose) 1
• Pre-implantation and post-implantation losses in rats 1

Clinical Algorithm for Pain Management in Second Trimester

First-line approach:

• Paracetamol (acetaminophen) is the recommended first-line medication for pain during pregnancy 3

Second-line approach (if paracetamol insufficient):

• Short-acting NSAIDs (ibuprofen preferred) may be considered only during weeks 14-28 of gestation 2, 3
• Maximum duration: 7-10 days 2, 3
• Lowest effective dose 2, 3
• Ibuprofen has the most reassuring safety data among NSAIDs 2

Celecoxib-specific considerations:

• Should only be considered in exceptional circumstances when other options have failed 4
• Requires intensive fetal monitoring with serial ultrasounds 1, 4
• Must be discontinued if used beyond 20 weeks and approaching 28 weeks 3, 1

Critical Pitfalls to Avoid

• Do not use celecoxib routinely for pain management in pregnancy when safer alternatives exist 2, 3
• Do not extend treatment beyond 48 hours without ultrasound monitoring for oligohydramnios and ductus arteriosus constriction 1
• Do not use any NSAID after 28-30 weeks gestation due to unacceptable fetal risks 2, 3, 1
• Do not assume COX-2 selectivity provides safety in pregnancy—the fetal risks are mechanism-based and apply to all NSAIDs 1