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FDA Approves Reintroduction of IBS Medication

On March 29th, 2019, the United States Food and Drug Administration (FDA) allowed the reintroduction of Zelnorm (tegaserod) for the treatment of Irritable Bowel Syndrome with constipation (IBS-C). Zelnorm will be given in a twice-daily dosage and is approved for the use in adult women under the age of 65.1,2 Currently, Zelnorm is the only selective serotonin (5-HT4) receptor agonist approved to treat IBS-C. Within the first four weeks of use, significantly more Zelnorm patients saw a reduction of their symptoms than patients on placebos in clinical trials. Patients who were on Zelnorm for four weeks also saw their frequency in bowel movements increase from an average of fewer than four movements a week to more than six movements per week. The safety and effectiveness of Zelnorm in men with IBS-C has not been tested.

History of Zelnorm

Zelnorm had been previously approved by the FDA in 2002 for women with IBS-C but was voluntarily withdrawn from the market in 2007. The medication was withdrawn due to cardiovascular safety concerns, but despite the withdraw, the medication was still available for specific populations through an FDA expanded access program.1 Patients who continued to take Zelnorm had to be women under the age of 55 with no history of heart problems.2

In October of 2018, an FDA Gastrointestinal Drugs Advisory Committee (GIDAC) reviewed data from 29 placebo-controlled trials and other new sources of treatment outcome data. The GIDAC overwhelmingly (11-1) voted to reintroduce Zelnorm for women with no more than one risk factor for cardiovascular disease and no history of ischemic cardiovascular disease.2

Serious side effects of Zelnorm

As with all medications Zelnorm can have side effects, and some of these can be serious. Some of the most serious side effects of Zelnorm are:1

  • Major cardiovascular side effects, such as heart attack, stroke, and death
  • Ischemic colitis and other intestinal problems
  • Diarrhea, including severe diarrhea
  • Increased risk of suicidal thoughts and behaviors

Other common side effects of Zelnorm are:1

You should talk to your health care team about Zelnorm, and discuss the risks versus the benefits. You should discuss your cardiovascular risk factors, any kidney or liver problems you have or have had in the past, any mental health issues you have or have had in the past, and if you are considering getting pregnant, are pregnant, or if you are nursing.1

If you and your health care team decide that Zelnorm is the right choice for your health care needs, you should be aware of the symptoms of a heart attack, stroke, mini-stroke (transient ischemic attack) and angina. If you have any symptoms, you should get emergency medical help immediately.1

If you notice you have any rectal bleeding, bloody or severe diarrhea, increased severe abdominal pain, or dizziness, you should contact your healthcare team right away.1

Your family and friends should monitor you for any changes in behavior, and if you have any unusual changes in behavior or mood, and suicidal or self-harm thoughts, or worsening symptoms of depression, you should contact your health care team right away.1

Though patients with Zelnorm should be monitored closely, this medication has been proven effective in treating patients with IBS-C and opens therapy options where there has been a gap in patient needs.

  1. FDA approves the reintroduction of Zelnorm™ (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65. Prnewswire.com. https://www.prnewswire.com/news-releases/fda-approves-the-reintroduction-of-zelnorm-tegaserod-for-irritable-bowel-syndrome-with-constipation-ibs-c-in-women-under-65-300821611.html. Published 2019. Accessed April 7, 2019.
  2. Brooks M. FDA OKs Reintroduction of Tegaserod for IBS-C in Women Under 65. Medscape. https://www.medscape.com/viewarticle/911237. Published 2019. Accessed April 7, 2019.

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