The FDA has expanded the indication for linaclotide to children as young as age 6 years with functional constipation, making it the first approved treatment for pediatric functional constipation.
The US Food and Drug Administration has expanded the indication for linaclotide to children as young as age 6 years with functional constipation, making it the first approved treatment for pediatric functional constipation.Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
They also had to experience one or more of the following at least once weekly, for at least 2 months prior to the trial screening visit:History of painful or hard bowel movementsPresence of a large fecal mass in the rectumThe primary efficacy endpoint was a 12-week change from baseline in SBM frequency rate. Children on linaclotide experienced greater improvement in the average number of SBMs per week than peers given placebo.
The most common adverse reaction is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
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