The U.S. Food and Drug Administration approved the drug developed by Ironwood Pharmaceuticals and Forest Laboratories on Aug. 30, 2012. The agency determined, however, that Linzess could not be considered safe and effective for children and teens younger than 17 years and asked the drugmakers to add a boxed warning to product labeling advising against prescribing the medication to younger patients. Animal studies on the use of Linzess in pediatric patients continue.
Patients should take a single Linzess capsule once each day, at least half an hour before eating their first meal. A higher dose of 290 micrograms is recommended for IBS sufferers, and a dose half that is recommended for people experiencing chronic constipation.
When announcing the drug's approval, Ironwood and Forest pointed particularly to the pain-relieving effects of Lizness.
The most common side effects experienced by patients taking Linzess during clinical trials were diarrhea, gas, stomach swelling and abdominal pain. In addition to the age warning, the drug's label states that Linzess should not be given to people whose intestines are blocked.
Here is the full prescribing information for Linzess.
Illustration courtesy of the National Institute of Diabetes and Digestive and Kidney Diseases