Linzess: First Drug Approved for Children and Adolescents With IBS-C

2 min read

What Is It, and Why Does It Matter?

Linzess (linaclotide) is a prescription medicine that helps ease constipation caused by irritable bowel syndrome (IBS-C). It works by drawing more fluid into your intestines, which makes it easier for stool to pass. The FDA has now approved it to treat IBS-C in children ages 7 years and older. This is first drug approved for this condition in this age group.

IBS-C is a digestive issue that is estimated to occur in 1%-3% of children and adolescents in the United States, but IBS may not be recognized as the cause of constipation in many people. It can cause stomach pain, bloating, and hard or infrequent bowel movements. While the exact cause isn’t clear, the symptoms can affect your child’s comfort and daily life. This approval gives families and health care providers a new option to help manage these symptoms. 

Why Was It Approved?

Linzess was approved for children with IBS-C based on results from a 12-week study. In the study, kids who took Linzess had more regular bowel movements and less stomach pain than those who took a placebo. About 3 in 10 children who took Linzess met the main goal of the study, which was having both fewer symptoms and more bowel movements for at least half of the treatment period.

The most common side effect was diarrhea. In some cases, it was serious enough that the medicine had to be stopped. The safety results in children were similar to what has been seen in adults. 

What Do I Need to Know?

Linzess is taken by mouth once a day on an empty stomach, at least 30 minutes before eating. 

Do not give Linzess to children under 2 years old. It can cause serious diarrhea and dehydration in very young children. Also, your child should not take Linzess if they have a known or suspected blockage in the intestines.

If your child has severe diarrhea while taking Linzess, stop the medicine and contact your health care provider right away. Linzess may be a helpful option if your child has ongoing constipation and stomach pain that hasn’t improved with other treatments.