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tegaserod (Zelmac, Zelmorm)

Withdrawn from US market 2007* [8] & again in 2022. Indications: 1) irritable bowel syndrome with constipation as predominant symptom 2) demonstrated to be effective ONLY in women 3) chronic idiopathic constipation in men & women [5,6] 4) may be useful for [3,4] b) gastroparesis c) GERD * restricted use under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) & chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines [9] Contraindications: 1) severe renal or hepatic impairment 2) history of intestinal obstruction 3) gallbladder disease Dosage: -> 6 mg PO BID, at least 30 minutes before meals Pharmacokinetics: -> expect modest improvement, usually within a month Adverse effects: 1) diarrhea generally resolves with continued treatment -> discontinue for severe diarrhea 2) reports of ischemic colitis [4] 3) increased risk of serious cardiovascular events (0.1%) (withdrawn from US market 2007) Mechanism of action: 1) partial 5HT-5 receptor agonist [2] 2) stimulates bowel motility to reduce abdominal pain, bloating & constipation 3) modestly effective (response of chronic constipation to tegaserod 6 mg BID is 40% vs 27% placebo) [6] Notes: Manufacturer: Novartis Cost about $137-180/month (2003-2005) [3,6]

Related

irritable bowel syndrome (IBS)

General

gastrointestinal agent

Database Correlations

PUBCHEM correlations

References

  1. Prescriber's Letter 7(8):44 2000
  2. Prescriber's Letter 9(8):45 2002
  3. Prescriber's Letter 10(7):42 2003
  4. Prescriber's Letter 11(6):31-32 2004 FDA Updates Zelnorm Labeling with New Risk Information Detail-Document#: 200602 (subscription needed) http://www.prescribersletter.com
  5. Prescriber's Letter 11(10): 2004 Zelnorm for Chronic Constipation Detail-Document#: 201003 (subscription needed) http://www.prescribersletter.com
  6. Journal Watch 25(7):58, 2005 Kamm MA, Muller-Lissner S, Talley NJ, Tack J, Boeckxstaens G, Minushkin ON, Kalinin A, Dzieniszewski J, Haeck P, Fordham F, Hugot-Cournez S, Nault B. Tegaserod for the treatment of chronic constipation: a randomized, double-blind, placebo-controlled multinational study. Am J Gastroenterol. 2005 Feb;100(2):362-72. Erratum in: Am J Gastroenterol. 2005 Mar;100(3):735. PMID: 15667494
  7. FDA MedWatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm
  8. Prescriber's Letter 14(5): 2007 Zelnorm (Tegaserod): Withdrawn From the U.S. Market Detail-Document#: 230504 (subscription needed) http://www.prescribersletter.com - Focht M Irritable Bowel Syndrome Therapy Removed From Market (Again). Medscape. June 30, 2022 https://www.medscape.com/viewarticle/976460
  9. FDA MedWatch: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm
  10. Prescriber's Letter 14(9): 2007 Detail-Document#: 230906 FDA permits restricted use of Zelnorm for qualifying patients (subscription needed) http://www.prescribersletter.com