š¢ FDA Approves Linzess (Linaclotide) Capsules for Pediatric Functional Constipation Treatment! š
13 Jun 2023 ⢠š The FDA has granted approval for Linzess (linaclotide) capsules as the first-ever treatment for pediatric functional constipation in patients aged 6 to 17 years. Functional constipation is a common condition in children and adolescents, characterized by infrequent and hard-to-pass bowel movements. š½
š¬ Clinical trials, including a 12-week double-blind study demonstrated the efficacy of Linzess. Pediatric patients experienced a significant improvement in the average number of spontaneous bowel movements per week compared to those who received a placebo. š
š The recommended dosage is 72 mcg orally once daily. However, it is important to note that patients under 2 years old should not take Linzess due to potential risks. Additionally, individuals with known or suspected mechanical gastrointestinal obstruction should avoid the medication. If severe diarrhea occurs, patients should discontinue Linzess and seek rehydration. š¦
This groundbreaking approval provides hope and relief for pediatric patients struggling with functional constipation! š
Source: US Food & Drug Administration | Read full story