In the current approval, the FDA has allowed using Linzess for treating functional constipation (FC) in children who are 2-5 years old.
Previously, it was only cleared for managing FC in children aged 6 years and older.
In children, FC is a long-term condition marked by difficult, hard, or infrequent bowel movements, without any known causes.
FC is commonly seen in preschool‑age children, affecting about 3% of them around the world. Linzess is a type of guanylate cyclase‑C agonist that contains linaclotide, a peptide that activates receptors in your gut. This draws more fluid into your intestines, helping the stools move faster and more easily. Linzess is not a traditional laxative and is also used for treating chronic idiopathic constipation (CIC) in adults and IBS‑C in adults, adolescents, and children ages 7 years and older. This approval matters because Linzess is now the only FDA-approved prescription medicine for treating FC in children ages 2-5 years, helping address a treatment gap for very young patients with limited treatment choices.
Why Was It Approved?
The FDA’s approval for children ages 2-5 years was based on a 12‑week study comparing Linzess to a placebo. Children who took Linzess once daily had more spontaneous bowel movements (SBMs) than those on a placebo. The improvement in SBM was seen as early as the first week and lasted throughout the 12 weeks of therapy. In pooled safety data for ages 2-5 years, one child reported mild diarrhea in the first week, which went away without treatment being stopped. The most common side effect is diarrhea, which can sometimes be severe and may lead to serious dehydration. Overall, the safety results in this age group were generally similar to those seen in adults with CIC and in older children with FC.
What Do I Need to Know?
For children ages 2 years and older with FC, the dose is 72 mcg once daily. Your child should swallow the capsule whole, on an empty stomach, not sooner than 30 minutes before a meal, and preferably at the same time each day. If your child is unable to swallow a capsule, you can open the capsule and sprinkle the beads on applesauce or mix it with water, then give it to your child right away. You can also give it through certain feeding tubes as instructed by your health care provider. Do not break, crush, or chew the beads. If you miss a dose, skip it and give the next dose at its usual time. Do not give two doses together.
