The FDA recently approved linaclotide (Linzess, Ironwood) to treat pediatric patients 7 years of age and older who have irritable bowel syndrome with constipation, making it the first approved treatment for pediatric IBS-C.
The approval follows results of a 12-week trial that showed efficacy similar to that seen in adults treated for IBS-C, according to an FDA news release. The primary end points were a “30% reduction in abdominal pain and an increase of at least two spontaneous bowel movements per week from baseline for at least 6 weeks [of the trial].”
The most common side effect was diarrhea, the FDA reported. Patients younger than 2 years of age can be at risk for dehydration and should not take linaclotide for any indication. In addition, patients with suspected bowel obstruction should not use the medication.
The once-daily oral pill was approved for adults with IBS-C or chronic idiopathic constipation in 2012 and for younger patients with functional constipation in 2023.
—GEN Staff
