HealthDay News — The FDA has approved linaclotide (Linzess, Ironwood Pharmaceuticals) to treat forms of chronic constipation that don’t respond to traditional treatment and irritable bowel syndrome (IBS) accompanied by constipation.

Approximately 63 million people are affected by chronic constipation, and about 15.3 million have IBS, the National Institutes of Health estimate. Linaclotide should be taken once daily on an empty stomach, at least 30 minutes before the first meal.

The FDA granted approval after results from two double-blind clinical trials involving 1,604 patients randomly assigned to 290 mg of linaclotide or placebo for at least 12 weeks showed that linoclotide was more effective in reducing the amount of abdominal pain and increasing the number of complete spontaneous bowel movements than placebo. The most frequently noted adverse reaction was diarrhea.

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Linaclotide’s drug label contains a boxed warning stating that the drug should not be taken by people aged 17 years or younger.