IBS subtype in children receives first FDA approval

The U.S. Food and Drug Administration approved the use of linaclotide in pediatric patients aged 7 years and older who have irritable bowel syndrome with constipation.

The approval followed positive findings indicating that the drug was effective in reducing abdominal pain and increasing spontaneous bowel movements each week. The safety and efficacy of linaclotide mirrored findings from trials involving adult patients with IBS with constipation. The drug was contraindicated in patients under 2 years of age as a result of the risk of severe dehydration.

The FDA’s action marked the first treatment approval in this patient population.

Read more: FDA

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