The FDA has approved Linzess capsules for treating irritable bowel syndrome with constipation in pediatric patients seven years and older, according to a Nov. 5 news release.
Here are five things to know:
1. Linzess is now the first treatment approved for pediatric IBS-C.
2. The approval was based on adult efficacy data and a 12-week, double-blind trial involving patients ages seven to 17 who met criteria for pediatric IBS-C.
3. Participants needed to demonstrate at least a 30% reduction in abdominal pain and two or more additional spontaneous bowel movements per week for at least six of the 12 study weeks.
4. Side effects in pediatric patients were similar to adults. The most common was diarrhea, and the FDA recommends discontinuation and rehydration if severe diarrhea occurs.
5. Linzess is not approved for children under 2 years due to the risk of serious dehydration.
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