Chymoral Forte Should Not Be Given to Children
Chymoral Forte (trypsin-chymotrypsin enzyme combination) is not recommended for use in children due to the absence of FDA approval, lack of established pediatric safety data, and insufficient evidence from well-controlled studies in the pediatric population. 1
Regulatory and Safety Considerations
The fundamental issue with Chymoral Forte in children is the lack of regulatory approval and safety evidence:
- The FDA requires specific approval with established safety and efficacy data for medications used in children, and Chymoral Forte lacks this approval for pediatric populations 1
- Pharmacotherapy in children and adolescents should only include approved medications with established safety profiles, as recommended by the American Academy of Pediatrics 1
- The use of unapproved medications in children requires extreme caution due to lack of well-controlled studies and long-term safety data 1
Why Pancreatic Enzymes Are Different
While pancreatic enzyme replacement therapy (PERT) is well-established for specific pediatric conditions, Chymoral Forte is fundamentally different:
- Approved pancreatic enzyme formulations are used in children with documented pancreatic insufficiency (such as cystic fibrosis), where they are FDA-approved with established dosing protocols 2
- Chymoral Forte is a proteolytic enzyme combination marketed for anti-inflammatory purposes, not for pancreatic insufficiency, and lacks the regulatory framework that approved PERT products have 3, 4
Clinical Practice Standards
The evidence strongly supports a conservative approach:
- Healthcare providers should recommend only FDA-approved therapies with established pediatric safety profiles, as suggested by the American Academy of Pediatrics and the American College of Clinical Pharmacy 1
- Even for approved medications, pediatric pharmacotherapy requires close monitoring by qualified healthcare providers 1
- 50-90% of drugs used in children have never been studied in this population, making it particularly important to avoid medications without pediatric data 5
Common Pitfalls to Avoid
- Do not extrapolate adult dosing or safety data to children, as pediatric populations represent a spectrum of different physiologies with significant variation in pharmacodynamics and pharmacokinetics 5
- Avoid off-label or unlicensed medications in children when approved alternatives exist 5
- Do not assume that "natural" enzyme products are inherently safe in children without proper safety studies 1
Alternative Approach
If pancreatic enzyme supplementation is genuinely needed in a child, use only FDA-approved PERT formulations with established pediatric dosing (such as for documented pancreatic insufficiency in cystic fibrosis or other conditions) 2. For anti-inflammatory purposes, consider approved pediatric anti-inflammatory medications with established safety profiles rather than unapproved enzyme combinations 1.