FDA approves Linzess (Linaclotide) for kids 7+ with IBS-C: First-ever treatment for pediatric constipation pain

The FDA just approved a new medication called Linzess (linaclotide) for kids aged 7 and older who have irritable bowel syndrome with constipation (IBS-C). This is a big deal because until now, there wasn’t an approved drug for younger kids with this specific problem, doctors had to use other options, and none were officially cleared by the FDA for this age group.

What is IBS-C?
IBS-C stands for irritable bowel syndrome with constipation. It’s a stomach issue that impacts both kids and adults. If you have IBS-C, you usually deal with tummy pain, bloating, and hard, infrequent poops that are tough or painful to pass. It can make kids feel pretty miserable and mess with their mood and even their school life. IBS-C isn't caused by something obviously “broken” in the body—it's more about the gut not working the way it should, and many things can play a role, like stress or certain foods.

How does Linzess help?
Linzess works by helping the intestines move things along more smoothly and increasing the amount of fluid in your bowels, making stool softer and easier to pass. The FDA decided it was safe and effective for children based on data from studies in both adults and kids. In a 12-week trial in kids ages 7 to 17, Linzess helped more children have at least two more bowel movements per week, and a noticeable drop (at least 30%) in belly pain—compared to how they felt before starting the medicine.

How safe is it?
The safety of Linzess looks similar whether you’re a kid or an adult. The most common side effect is diarrhea. While that may sound worrying, most cases are mild. If diarrhea gets serious, kids should stop taking the medicine and make sure they stay well-hydrated. It’s super important to know that Linzess is NOT for children under 2 years old because it can cause severe dangerous dehydration in babies and toddlers. It’s also not to be taken by anyone with a bowel blockage.

How do you take it?
For kids 7 and up with IBS-C, the recommended dose is 145 micrograms (mcg) once a day, taken by mouth. It’s a capsule, so older kids and teens shouldn’t have trouble swallowing it. Like with all new medications, it’s best used under a health provider’s supervision to make sure it’s safe and to watch out for any side effects.

Why is this approval important?
This approval means doctors and families have a proven, FDA-reviewed option for treating IBS-C in younger kids—not just trial and error or off-label use. That's good news because childhood constipation and IBS can be tough to manage, and now there's a medication tested to help with both the pain and the “blockage” part of things.

So if you know a child struggling with ongoing belly troubles and constipation, this new approval could mean some real relief is finally available—with government health experts making sure it’s safe and effective.