FDA Approves Linzess for Children with IBS-C: A First in Paediatric Care

The United States Food and Drug Administration (FDA) has approved Linzess (linaclotide) for children aged seven years and older suffering from Irritable Bowel Syndrome with Constipation (IBS-C). This marks the first-ever FDA-approved medication for this condition in paediatric patients, offering a breakthrough in the treatment of chronic constipation and abdominal pain among children.

Understanding IBS-C in Children

IBS-C is a functional bowel disorder that affects both children and adults, causing abdominal discomfort, bloating, and hard, infrequent bowel movements. The condition can severely impact a child’s daily life, including emotional well-being and school performance. Unlike structural gut problems, IBS-C stems from how the intestines function, influenced by factors like stress, diet, and gut sensitivity.

How Linzess Works

Linzess, known generically as linaclotide, enhances bowel movement by increasing intestinal fluid secretion and promoting motility. The medicine was tested in both adult and paediatric populations, with a 12-week clinical trial showing significant improvement in children aged 7–17. Participants experienced at least two additional bowel movements per week and a 30% reduction in abdominal pain.

Safety and Dosage Details

The recommended paediatric dosage is 145 micrograms (mcg) once daily, taken orally. The most common side effect is mild diarrhoea. In rare cases of severe diarrhoea, treatment should be stopped and hydration maintained. Linzess is not approved for children under two years old due to the risk of dangerous dehydration and must not be used by anyone with a bowel blockage.

Exam Oriented Facts

• Linzess (linaclotide) is the first FDA-approved treatment for IBS-C in children aged 7 years and above.
• IBS-C causes abdominal pain and constipation without visible structural abnormalities in the gut.
• The FDA approval followed a 12-week trial showing improved bowel frequency and reduced pain.
• Linzess is contraindicated in children under 2 years due to risk of dehydration.

Significance of the FDA Approval

This approval provides doctors and families with the first evidence-based, FDA-reviewed option for treating paediatric IBS-C, reducing reliance on off-label therapies. It offers renewed hope for children struggling with chronic constipation and abdominal discomfort, ensuring safe, regulated care that meets international medical standards.