Functional constipation in children can be a significant cause of concern owing to the apparent lack of a clear systemic cause. As such, its management can be quite complex, requiring frequent disimpaction along with pharmacological therapy. The USFDA recently approved a novel oral therapy called linaclotide for pediatric patients aged 6-17 years with functional constipation. The approval was based on the results of a phase III trial comprising of 328 patients randomized to receive either oral therapy of 72 mcg linaclotide or a placebo.
Endpoint: Patients in the treatment group showed an average 2.6 times change in frequency of spontaneous bowel movement per week. Recommended dosage: 72 mcg administered orally once every day Adverse events included diarrhea, abdominal pain, abdominal distension, and flatulence. The drug is contraindicated in patients below two years of age due to the…
