tegaserod (Zelmac, Zelmorm)
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Introduction
Withdrawn from US market 2007*[8] & again in 2022.
Indications
- irritable bowel syndrome with constipation as predominant symptom
- demonstrated to be effective ONLY in women
- chronic idiopathic constipation in men & women[5][6]
- may be useful for[3][4]
* 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
- severe renal or hepatic impairment
- history of intestinal obstruction
- gallbladder disease
Dosage
Pharmacokinetics
- expect modest improvement, usually within a month
Adverse effects
- diarrhea generally resolves with continued treatment
- discontinue for severe diarrhea
- reports of ischemic colitis[4]
- increased risk of serious cardiovascular events (0.1%) (withdrawn from US market 2007)
Mechanism of action
- partial 5HT-5 receptor agonist[2]
- stimulates bowel motility to reduce abdominal pain, bloating & constipation
- 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]
More general terms
Additional terms
References
- ↑ Prescriber's Letter 7(8):44 2000
- ↑ 2.0 2.1 Prescriber's Letter 9(8):45 2002
- ↑ 3.0 3.1 3.2 Prescriber's Letter 10(7):42 2003
- ↑ 4.0 4.1 4.2 Prescriber's Letter 11(6):31-32 2004 FDA Updates Zelnorm Labeling with New Risk Information Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=200602&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 5.0 5.1 Prescriber's Letter 11(10): 2004 Zelnorm for Chronic Constipation Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=201003&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 6.0 6.1 6.2 6.3 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: https://www.ncbi.nlm.nih.gov/pubmed/15667494
- ↑ FDA MedWatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm
- ↑ 8.0 8.1 Prescriber's Letter 14(5): 2007 Zelnorm (Tegaserod): Withdrawn From the U.S. Market Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=230504&pb=PRL (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 - ↑ 9.0 9.1 FDA MedWatch: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm
- ↑ Prescriber's Letter 14(9): 2007 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=230906&pb=PRL FDA permits restricted use of Zelnorm for qualifying patients (subscription needed) http://www.prescribersletter.com