The U.S. Food and Drug Administration (FDA) has officially approved Linzess (linaclotide) for treating Irritable Bowel Syndrome with Constipation (IBS-C) in children aged seven years and older. This marks the first-ever FDA-approved medication for paediatric IBS-C, offering new hope for children suffering from chronic constipation and abdominal pain.
FDA Approves Linzess as First Treatment for IBS-C in Children Aged 7 and Above
Understanding IBS-C in Children
IBS-C (Irritable Bowel Syndrome with Constipation) is a functional bowel disorder that causes:
- Abdominal pain and bloating
- Hard, infrequent bowel movements
- Discomfort affecting mood and school performance
Unlike structural issues in the intestines, IBS-C is related to how the gut functions. It is influenced by diet, stress, and intestinal sensitivity, often making daily life challenging for young patients.
How Linzess Works
Linzess, also known as linaclotide, helps regulate bowel movement by:
- Increasing fluid secretion in the intestines
- Improving intestinal motility
- Easing abdominal discomfort
A 12-week clinical trial in children aged 7–17 years showed promising results:
- Participants had two or more additional bowel movements per week
- A 30% reduction in abdominal pain was reported
These results led to the FDA’s approval, confirming Linzess as both effective and safe for paediatric use.
Safety and Dosage
- Recommended Dose: 145 micrograms (mcg) once daily (oral).
- Common Side Effect: Mild diarrhoea.
- Precaution: In case of severe diarrhoea, stop treatment and ensure hydration.
- Warning: Not approved for children under 2 years old, as it can cause severe dehydration.
- Should not be used by anyone with a bowel blockage.
Significance of the FDA Approval
This approval is a major medical milestone. For the first time, doctors and families now have an FDA-reviewed, evidence-based treatment for paediatric IBS-C. It reduces dependence on off-label or unregulated therapies and ensures that children receive safe, standardised care under global medical guidelines.
Exam-Oriented Notes
- Linzess (linaclotide) – First FDA-approved drug for IBS-C in children aged 7+.
- Condition: IBS-C causes constipation and abdominal pain without structural gut issues.
- Trial Duration: 12 weeks, showing improved bowel frequency and reduced pain.
- Dosage: 145 mcg once daily.
- Not for: Children under 2 years (risk of dehydration).
Question & Answer
Q1. Which drug has been approved by the FDA for treating IBS-C in children aged 7 and above?
(a) Omeprazole
(b) Linzess (linaclotide)
(c) Loperamide
(d) Domperidone
Answer: Linzess (linaclotide)**
Q2. Linzess has been approved for which medical condition in children?
(a) Ulcerative colitis
(b) Irritable Bowel Syndrome with Constipation (IBS-C)
(c) Crohn’s disease
(d) Diarrhoea-predominant IBS
Answer: Irritable Bowel Syndrome with Constipation (IBS-C)**
Q3. What is the recommended paediatric dose of Linzess for IBS-C?
(a) 50 mcg once daily
(b) 145 mcg once daily
(c) 200 mcg twice daily
(d) 500 mcg once daily
Answer: 145 mcg once daily**
Q4. Why is Linzess not approved for children under 2 years old?
(a) It is ineffective
(b) Causes dehydration
(c) Causes allergy
(d) Not tested in infants
Answer: Causes dehydration**
Q5. How long was the clinical trial conducted before FDA approval of Linzess for children?
(a) 6 weeks
(b) 8 weeks
(c) 12 weeks
(d) 24 weeks
Answer: 12 weeks**
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