What is the age limit for prescribing Anafranil (clomipramine) for obsessive-compulsive disorder?

Age Limits for Prescribing Anafranil (Clomipramine) for OCD

Anafranil (clomipramine) is FDA-approved for treating OCD in patients 10 years of age and older, with no upper age limit specified, though caution is advised in elderly patients. 1

Age-Related Prescribing Guidelines

Lower Age Limit

• Clomipramine has been specifically studied and approved for children and adolescents 10-17 years of age with OCD 1
• Safety and effectiveness in pediatric patients below the age of 10 have not been established, and therefore specific recommendations cannot be made for this age group 1
• The FDA label explicitly states that the medication was studied in children as young as 10 years old in controlled clinical trials 1

Upper Age Limit

• There is no specific upper age limit for prescribing clomipramine
• The FDA label mentions that clinical studies included 152 patients at least 60 years of age who received clomipramine for periods ranging from several months to several years 1
• For elderly patients, dose selection should be cautious, typically starting at the lower end of the dosing range due to:
  • Greater frequency of decreased hepatic, renal, or cardiac function
  • Higher likelihood of concomitant disease or drug therapy
  • Increased risk of clinically significant hyponatremia 1

Dosing Considerations by Age Group

Children and Adolescents (10-17 years)

• Maximum dose: 3 mg/kg/day up to 200 mg 1
• In clinical trials, children and adolescents experienced approximately 37% improvement on the Yale-Brown Obsessive Compulsive Scale 1
• Adverse reaction profile in this age group is similar to that observed in adults 1

Adults

• Maximum dose: 250 mg/day for most adults 1
• Adults typically experienced 35-42% improvement on the Yale-Brown Obsessive Compulsive Scale in clinical trials 1

Elderly Patients (65+ years)

• Lower starting doses recommended
• Careful monitoring required, especially for hyponatremia 1
• No unusual age-related adverse events were identified in the elderly population studied 1

Important Monitoring Considerations

• Long-term effects: The risks associated with extended use in children and adolescents have not been systematically assessed 1
• Growth and development: While there is no evidence suggesting clomipramine adversely affects growth, development, or maturation, the absence of such findings is not adequate to rule out potential effects in chronic use 1
• Periodic reevaluation: For extended treatment periods (beyond 10 weeks), physicians should periodically reevaluate the long-term usefulness of the drug for the individual patient 1
• Cardiovascular monitoring: Particularly important in combination therapy, as studies have shown potential for QTc interval prolongation and tachycardia 2

Special Considerations for Refractory OCD

For severe, treatment-resistant OCD requiring more intensive interventions, guidelines suggest:

• Age 18-75 years for consideration of surgical interventions for refractory OCD 3
• Increasing age is noted as a relative contraindication for surgical interventions 3

In summary, clomipramine is approved for patients 10 years and older with OCD, with appropriate dose adjustments and monitoring based on age group. While there is no specified upper age limit, careful consideration of risks and benefits is particularly important in elderly patients.