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FDA Approves 1st Drug for Children 7 Years and Older with Irritable Bowel Syndrome with Constipation
Action
The U.S. Food and Drug Administration (FDA) has approved Linzess (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). Linzess is the first treatment approved for IBS-C in pediatric patients.
Disease or Conditions
IBS-C is a common condition affecting children and adolescents characterized by chronic constipation (which occurs when patients have infrequent bowel movements with hard stools that may be difficult or painful to pass), abdominal pain, and bloating. There is no known underlying organic cause and there are typically multiple contributing factors.
Efficacy
The effectiveness of Linzess to treat IBS-C was established in pediatric patients 7 years and older. Linzess for this indication was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7 to 17 years who met modified Rome III criteria for child/adolescent IBS-C. The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two spontaneous (i.e., naturally occurring) bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period. The efficacy results were consistent with results demonstrated in the adult IBS-C population.
Safety
The safety of Linzess in these clinical studies was similar in adult and pediatric patients. The most common side effect reported in pediatric patients 7 to 17 years with IBS-C was diarrhea. If severe diarrhea occurs, patients should discontinue Linzess and be rehydrated. Patients younger than 2 years can be at risk of serious dehydration and should not take Linzess for any indication, nor should patients with known or suspected mechanical gastrointestinal obstruction (bowel blockage). See the full prescribing information for additional information on risks associated with Linzess.
The recommended dosage for pediatric patients 7 years and older with IBS-C is 145 mcg orally once daily.
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