New IBS Rx Gets Green Light

FDA approves Ibsrela (tenapanor) for irritable bowel syndrome with constipation

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to treat irritable bowel syndrome with constipation.

This newly approved tablet medication is called Ibsrela (brand name) and tenapanor (active ingredient). The FDA approved it to treat adults who have irritable bowel syndrome with constipation (IBS-C).

Tenapanor's approval comes after two clinical trials showed the medication to be effective in reducing constipation and stomach pain in adults with IBS.

It is to be taken by mouth twice a day on an empty stomach (before the first meal of the day and right before dinner).

Common side effects of Ibsrela included stomach bloating, diarrhea, gas and dizziness. Serious side effects may include severe diarrhea. If you experience severe diarrhea, let your doctor know.

Tenapanor comes with a boxed warning regarding the drug's use in children. In children, this medication may pose a risk of severe diarrhea, which can lead to severe dehydration.

This approval was granted to Ardelyx, Inc.

Speak with your health care provider if you have any questions about this medication or IBS.

Written by Anyssa Garza, PharmD, BCMAS