Safety Insights from the EASE‑O‑MAPP Study: Mefenamic Acid Oral Suspension in Pediatric Practice

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Safety remains a primary concern for pediatricians when selecting antipyretic therapy, particularly with NSAIDs. The EASE‑O‑MAPP study provides real‑world clinical evidence on the safety and tolerability of mefenamic acid oral suspension when used in children with febrile illness.

Comprehensive Safety Evaluation

In the EASE‑O‑MAPP observational study, safety was systematically assessed through clinical monitoring, laboratory investigations, urinalysis, fecal occult blood testing (FOBT), and a structured gastrointestinal (GI) symptom questionnaire. Fifty pediatric patients aged six months to under 18 years were evaluated at baseline and after completion of therapy.

Hematological Safety Findings

Hematological parameters remained stable throughout the study period. No clinically significant changes were observed in hemoglobin levels, total leukocyte count, platelet count, or red blood cell indices. Overall, the findings indicate that mefenamic acid oral suspension did not adversely affect hematological health.

Hepatic and Renal Safety Profile

Liver and kidney function parameters showed no evidence of treatment‑related toxicity. Serum transaminases (SGOT and SGPT), alkaline phosphatase, and bilirubin levels remained stable from baseline to Day 7. Similarly, renal function markers including blood urea nitrogen and serum creatinine demonstrated no statistically or clinically significant changes. These results confirm the hepatic and renal safety of mefenamic acid oral suspension at the recommended pediatric dose.

Urinary Findings

Urinalysis findings were largely unremarkable. Trace hematuria was observed in two subjects; however, these findings were transient, not associated with clinical symptoms, and were not considered treatment‑related.

Gastrointestinal Tolerability

Gastrointestinal safety was carefully evaluated using a structured symptom questionnaire and FOBT. None of the participating children reported GI symptoms such as abdominal pain, nausea, vomiting, bloating, heartburn, or altered bowel habits. Two subjects showed transient FOBT positivity during treatment, which resolved by follow‑up without any accompanying GI symptoms or clinical abnormalities. These isolated findings were not indicative of GI mucosal injury or bleeding.

Clinical Implications for Pediatric Practice

The EASE‑O‑MAPP study demonstrates that mefenamic acid oral suspension (MEFTAL-P), when used at a dose of 5 mg/kg three times daily, is well tolerated in pediatric patients, even in the presence of concomitant medications. The absence of treatment‑related adverse events and the stability of laboratory parameters reinforce its favorable short‑term safety profile.

For pediatricians, these findings provide reassurance that mefenamic acid oral suspension can be used safely for the symptomatic management of febrile illness in children when prescribed at recommended doses and with appropriate clinical judgment.

Key Takeaways of EASE-O-MAPP Study on Safety Parameters of Mefenamic acid

• In the EASE-O-MAPP study, mefenamic acid oral suspension (MEFTAL-P) showed a favorable safety profile in children aged six months to <18 years.
• No treatment-related adverse events or clinically significant changes were observed in hematological, hepatic or renal parameters.
• Excellent gastrointestinal tolerability was noted, with no reported GI symptoms and only transient, clinically insignificant FOBT findings.

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URL Reference:  https://www.meftal.com/product/meftal-p-mefenamic-acid-suspension

Reference: Khalatkar V, Kasture P N, Kumar D. Cureus. 2025; 17(12) : 1-10