For patients and healthcare providers managing Irritable Bowel Syndrome (IBS), the availability of medications can change due to various factors, including safety concerns, business decisions, or the introduction of generics. While new treatments emerge, some notable IBS drugs have been discontinued or faced restrictions over the years. The most recent is the permanent withdrawal of Zelnorm (tegaserod) in 2022.
The Discontinuation of Zelnorm (Tegaserod)
Zelnorm has a complex history. Initially approved by the U.S. Food and Drug Administration (FDA) in 2002 for the short-term treatment of IBS-C in women, it was withdrawn from the market in 2007.
Why was Zelnorm recalled in 2007?
The initial withdrawal in 2007 was due to a safety analysis showing a higher incidence of cardiovascular events in patients taking the drug compared to a placebo. The manufacturer voluntarily withdrew the drug at the FDA's request.
Why was Zelnorm withdrawn again in 2022?
Following a safety review, the FDA approved Zelnorm's reintroduction in 2019 with a restricted label for women under 65 with IBS-C and no history of heart disease. However, in June 2022, Alfasigma announced the permanent withdrawal of Zelnorm, citing a business-related decision, not safety concerns.
The Case of Lotronex (Alosetron): A Restricted Comeback
Lotronex (alosetron), approved in 2000 for women with severe diarrhea-predominant IBS (IBS-D), was withdrawn later that year due to serious gastrointestinal adverse events, including ischemic colitis.
Lotronex's return under restrictions
After re-evaluation, Lotronex was re-approved by the FDA in 2002 with a strict Risk Management Plan. It is now limited to a specific group of women with severe IBS-D who haven't responded to other treatments, and prescribing requires enrollment in a special program.
The Fate of Bentyl (Dicyclomine) Brand Name
The branded version of Bentyl (dicyclomine) has also been discontinued. Generic dicyclomine, an anticholinergic for intestinal spasms, remains available but is prescribed less often due to potential side effects.
Comparing Discontinued and Restricted IBS Drugs
| Drug | Status | Primary Reason for Discontinuation/Restriction | Year(s) Affected |
|---|---|---|---|
| Zelnorm (tegaserod) | Permanently discontinued in 2022 | Business decision (2022), Cardiovascular risks (2007) | 2007, 2022 |
| Lotronex (alosetron) | Restricted availability since 2002 | Severe gastrointestinal side effects | 2000 |
| Bentyl (dicyclomine) | Brand name discontinued, generics available | Shift to generics, side effect profile | May 2025 |
Modern Alternatives for IBS Management
Alternatives are available for both IBS-C and IBS-D.
Alternatives for IBS with Constipation (IBS-C)
- Linzess (linaclotide): Increases intestinal fluid and movement.
- Trulance (plecanatide): Increases intestinal fluid secretion.
- Tenapanor (Ibsrela): Reduces sodium absorption and increases water secretion.
- Lubiprostone (Amitiza): Increases intestinal fluid.
Alternatives for IBS with Diarrhea (IBS-D)
- Xifaxan (rifaximin): An antibiotic for gut bacteria.
- Viberzi (eluxadoline): Decreases bowel contractions.
- Over-the-counter options: Loperamide (Imodium).
Non-Pharmacological Treatments
Non-drug approaches can also help:
- Dietary changes: The low-FODMAP diet.
- Stress management: Techniques like mindfulness.
- Probiotics: Certain strains may help.
Conclusion: Navigating the Evolving Treatment Landscape
The discontinuation of drugs like Zelnorm and restrictions on others like Lotronex show that pharmaceutical treatments change. While challenging, this also leads to newer therapies. The final withdrawal of Zelnorm for business reasons, not safety, illustrates that market forces play a role in drug availability. With many alternatives available, patients should work with their healthcare providers to find the best treatment strategy.
