Mefenamic Acid Minimum Age
Mefenamic acid is indicated for patients ≥14 years of age according to FDA labeling, and should not be prescribed below this age threshold. 1
FDA-Approved Age Restriction
- The FDA explicitly states that mefenamic acid is indicated "for relief of mild to moderate pain in patients ≥14 years of age, when therapy will not exceed one week (7 days)" and "for treatment of primary dysmenorrhea." 1
- There is no approved pediatric indication for children under 14 years of age in the United States. 1
Duration Limitation
- Even in patients ≥14 years of age, mefenamic acid therapy should not exceed one week (7 days) for pain management. 1
- This duration restriction is critical to minimize gastrointestinal and other NSAID-related adverse effects. 1
Clinical Context
- While older research from 1977 studied mefenamic acid in children as young as 3 months for antipyretic effects, this does not reflect current regulatory approval or safety standards. 2
- The FDA approval age of ≥14 years represents the evidence-based safety threshold for clinical use. 1
Important Safety Considerations
- The FDA emphasizes using the lowest effective dose for the shortest duration consistent with individual patient treatment goals to minimize risks of gastrointestinal bleeding, ulceration, and perforation. 1
- Mefenamic acid carries typical NSAID risks including gastrointestinal toxicity, which informed the age restriction and duration limits. 1