Dr Veena Aggarwal
The US FDA has given the green signal for the use of linaclotide to treat functional constipation in children and adolescents. Occasional bowel movements with hard stools that are either difficult or painful to pass characterize functional constipation. There is also a history of withholding bowel movement. This makes Linaclotide the first approved treatment for this indication in the pediatric age group. It is marketed by the name of “Linzess” and is available as 72 mcg capsules.1,2
Linaclotide has earlier been FDA approved for use in adults with chronic idiopathic constipation and constipation-predominant irritable bowel syndrome (IBS-C).
Indication: Functional constipation (FC) in children aged 6 to 17 years
Dosage and administration: 72 µg orally once daily to be taken on an empty stomach at least half an hour before meals at the same time daily. The capsule should be swallowed whole and not chewed or crushed.
Side effects: Diarrhea (most common), nausea, dehydration
Contraindications
- Children younger than 2 years due to the risk of serious dehydration
- Patients with known or suspected mechanical gastrointestinal obstruction
Warnings and precautions
- Severe diarrhea may occur. In such cases, linaclotide should be discontinued and rehydration therapy should be initiated.
- Avoid prescribing linaclotide to children younger than 2 years of age.
References
- FDA News Release. Available at: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-pediatric-functional-constipation, 06/12/2023. Accessed on June 14, 2023.
- Linzess (linaclotide) capsules prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202811s021lbl.pdf.Accessed on June 14, 2023.