Novartis suspends tegaserod sales at FDA’s request

Thompson, Cheryl A.

doi:10.2146/news070044

Cited by 40 publications

(35 citation statements)

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“…Tegaserod was used to treat irritable bowel syndrome, but stands withdrawn due to the increased number of cardiovascular events (Beglinger, 2002;Thompson, 2007). In our study, maximum contractile response to tegaserod was observed at 10 μM, which is roughly 50,000 times the free concentration found in human plasma (total C max is 9 nM, plasma protein binding is 98% (Swan et al, 2003)) after administration of the usual clinical dosage (6 mg oral dose, Appel-Dingemanse, 2002;Appel-Dingemanse et al, 2001).…”

Section: Clinical Usementioning

confidence: 48%

“…For instance, the 5-HT 4 receptor agonist cisapride, which has also affinity for the 5-HT 2A receptor, has been clinically used as a gastroprokinetic agent, but was withdrawn in the U.S.A. due to its propensity to induce cardiac adverse effects (Farrington, 1996;Mohammad et al, 1997). Also, the partial 5-HT 4 receptor agonist tegaserod, which was introduced in the U.S.A. to treat irritable bowel syndrome, was withdrawn in 2007 after a meta-analysis indicating an increased number of cardiovascular ischemic events in treated patients (Beglinger, 2002;Thompson, 2007). The cardiac adverse events with cisapride and tegaserod are different in nature and both unrelated to 5-HT 4 receptors (Morganroth et al, 2002;Wysowski and Bacsanyi, 1996).…”

Section: Introductionmentioning

confidence: 99%

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Inotropic effects of prokinetic agents with 5-HT4 receptor agonist actions on human isolated myocardial trabeculae

Chai¹,

Chan²,

Vries³

et al. 2012

Life Sciences

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Section: Clinical Usementioning

confidence: 48%

Section: Introductionmentioning

confidence: 99%

Inotropic effects of prokinetic agents with 5-HT4 receptor agonist actions on human isolated myocardial trabeculae

Chai¹,

Chan²,

Vries³

et al. 2012

Life Sciences

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“…96 However, tegaserod was withdrawn from the market in 2007 as data from trials (88% female patients with iBs) showed that tegaserod (n = 11,614) had a 0.11% increased risk of cardio vascular events (myocardial infarction, stroke, transient ischemic attack) compared with 0.01% risk with revIews placebo (n = 7,031). 97 in the usa, tegaserod is available only under an FDa emergency drug protocol (table 3).…”

Section: Fiber and Bulking Agentsmentioning

confidence: 99%

Diagnosis and management of IBS

Khan¹,

Chang²

2010

Nat Rev Gastroenterol Hepatol

103

107

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IBS is a common gastrointestinal condition characterized by chronic or recurrent abdominal pain associated with altered bowel habits. IBS is considered a functional bowel disorder (that is, not defined by structural or biochemical abnormalities) and is diagnosed using symptom-based criteria. Limited and judicious use of diagnostic testing is recommended, particularly in patients with typical symptoms of IBS without alarm signs and symptoms. Management of IBS is based on a multifactorial approach and includes establishment of an effective patient-provider relationship, education, reassurance, dietary alterations, pharmacotherapy, behavioral and psychological treatment. Patient-centered care is recommended, in which management is focused on the patient's most bothersome and impactful symptoms, their preferences and previous experiences with treatment, and addressing factors associated with the onset and exacerbation of symptoms. Pharmacotherapy is typically targeted against the predominant symptom. This Review discusses the current evidence-based recommendations for the diagnosis and management of IBS. An improved understanding of the recommended diagnostic and therapeutic approaches for IBS will lead to greater patient satisfaction, as well as reduced health-care costs.

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“…However, concern about safety due to cardiotoxicity resulted in withdrawal of both promotility agents after they were approved by the FDA (Locke et al 2000;Altabas et al 2003;Johanson et al 2004;Müller-Lissner et al 2004;Thompson 2007).…”

Section: Unmet Needsmentioning

confidence: 99%

Prucalopride: the evidence for its use in the treatment of chronic constipation

Coremans¹

2008

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Introduction: Chronic constipation is a common condition that is difficult to treat. Existing options for the treatment of patients with different subgroups of constipation are limited. A new efficacious and safe drug is needed to limit the frequently observed adverse effects induced by laxatives, to improve general wellbeing and quality of life, and to provide an alternative for enemas or even resectional surgery in patients in whom stimulant laxatives cause disabling adverse effects or fail to increase bowel movement frequency.

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Novartis suspends tegaserod sales at FDA’s request

Cited by 40 publications

References 0 publications

Inotropic effects of prokinetic agents with 5-HT4 receptor agonist actions on human isolated myocardial trabeculae

Inotropic effects of prokinetic agents with 5-HT4 receptor agonist actions on human isolated myocardial trabeculae

Diagnosis and management of IBS

Prucalopride: the evidence for its use in the treatment of chronic constipation

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