Medications No Longer Approved To Treat IBS

Irritable bowel syndrome (IBS) can be a difficult disease to treat, and patients often must try several different treatment options before finding the one or a combination that works best for them. Despite the varying options available, people with IBS are frustrated with the treatments available. In a recent survey by the International Foundation for Functional Gastrointestinal Disorders (IFFGD) in conjunction with the University of North Carolina Center, only 8% of patients with IBS noted they were very or extremely satisfied with their all types of treatment, and one-third expressed they were not at all satisfied. There are some prescription medications on the market, but only one-third of patients are very or extremely satisfied with their current medications.1

Occasionally, medications that are approved by the FDA must be later taken off the market due to concern over serious side effects. There have been two such cases in IBS treatments: Zelnorm (tegaserod) and Lotronex (alosteron).

Zelnorm (tegaserod)

In March 2007, the FDA requested that Novartis, the manufacturer of Zelnorm, suspend their marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart or chest pain) in patients treated with Zelnorm compared to treatment with a placebo (inactive substance that produces no physical effect). Then, in July 2007, the FDA allowed restricted use of Zelnorm under the “treatment investigational new drug” process. Novartis later announced that they would no longer provide Zelnorm under a treatment investigational new drug application protocol to treat IBS. Novartis agreed to continue to supply Zelnorm in emergency situations, such as those that are immediately life-threatening or serious enough to qualify for hospitalization. Requests for Zelnorm in emergency situations must go through the FDA, which may deny authorization if it is deemed that the drug would pose an unreasonable or significant additional risk to the patient.2

Lotronex (alosteron)

Lotronex was approved for marketing by the FDA in February 2000, but was withdrawn from the market in November 2000 because of serious, life-threatening, gastrointestinal side effects. (Some patients experienced serious complications of constipation and reduced blood flow to the bowel, known as ischemic colitis. These side effects can happen suddenly and may lead to a hospital stay and in rare cases, blood transfusions, surgery and death.3) In June 2002, it was approved again by the FDA for marketing in a restricted manner as part of a sponsored program for managing the risks associated with treatment. This means that physicians who prescribe Lotronex must attest to having certain qualifications and agree to fulfill specific responsibilities, including informing their patients of the risks and benefits of Lotronex. Lotronex is only indicated for women with severe, diarrhea-predominant IBS who have failed to respond to other treatments for IBS.4

Affect on Patients

When the FDA has taken drugs that treat IBS off the market, it has significant impact on those people taking the products and receiving relief from their symptoms. The IFFGD survey found that of those patients who were taking one or both of the drugs that were removed from the market, 45% found the withdrawal considerably or completely disruptive to the control of their IBS. In addition, one-third found the withdrawal considerably or completely disruptive to their daily lives.1

Because of the severity of IBS symptoms and the impact IBS has on quality of life, some patients with IBS are willing to consider significant risks from their medications in order to receive relief. When asked how much risk they would assume to take a medication providing total relief from their IBS symptoms but with serious side effects, 8% of all respondents would accept a 1 in 100 chance of death to be symptom-free. For those with severe IBS, 15% would accept a 1 in 100 chance of death to be symptom-free, and 11% would accept a 1 in 100 chance of serious and disabling side effects to be symptom-free. These responses are striking and suggest just how crucial symptom relief is to the well-being of people living with IBS.1

Written by: Emily Downward | Last reviewed: June 2016.
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