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Kids who have irritable bowel syndrome with constipation (IBS-C) now have a new treatment option as the Food and Drug Administration (FDA) this month approved linaclotide for pediatric patients 7 years and older. There is no known underlying cause for IBS-C in children, and symptoms include chronic constipation and abdominal pain. Linaclotide is the first treatment approved for IBS-C in pediatric patients with a recommended dose of 145 mcg orally once daily. A 12-week, double-blind, randomized trial in children showed the drug exceeded the adult placebo responder rate of 16% for the primary endpoint of achieving at least a 30% reduction in abdominal pain and an increase of at least 2 spontaneous bowel movements per week from baseline for at least 6 of the 12 treatment weeks. The safety of linaclotide in clinical studies was similar in adult and pediatric patients, and the most common side effect reported in pediatric patients was diarrhea.
At the pharmacy: Linaclotide was approved for IBS-C in adults in 2012 and also for functional constipation in kids aged 6 years and older in 2023. Full prescribing information for linaclotide for pediatric IBS-C is available on the FDA website.