The FDA and  The Lancet : an exchange

Hirschfeld, Steven; Kieffer, Lydia; McGuinn, W. David; Rothmann, Mark D.; Timmer, William C.

doi:10.1016/s0140-6736(01)05561-1

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2003

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“… 9 However, alosetron was withdrawn from the market following reports of serious complications, including death 10 ,. 11 A spirited debate on the drug approval process followed 12–18 . The FDA has now approved the restricted distribution of alosetron for women with severe diarrhoea‐predominant irritable bowel syndrome who have failed conventional therapy 19 .…”

Section: Introductionmentioning

confidence: 99%

Safety, efficacy and costs of pharmacotherapy for functional gastrointestinal disorders: the case of alosetron and its implications

Ladabaum

2003

Aliment Pharmacol Ther

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SUMMARYBackground: Functional gastrointestinal disorders cause substantial morbidity, but not mortality. Alosetron may achieve 'adequate relief ' in diarrhoea-predominant irritable bowel syndrome, but may cause major complications, including death. Aim: To appraise, quantitatively, the trade-off between possible symptomatic improvement and serious complications in the treatment of functional gastrointestinal disorders. Methods: A decision analytical model was used to examine alosetron or standard treatment for 6 months in 45-year-old women with diarrhoea-predominant irritable bowel syndrome using the health care system's perspective. Results: Assuming a 14% higher 'adequate relief' rate with alosetron compared to standard care, and a

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Section: Introductionmentioning

confidence: 99%

Safety, efficacy and costs of pharmacotherapy for functional gastrointestinal disorders: the case of alosetron and its implications

Ladabaum

2003

Aliment Pharmacol Ther

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show abstract

The FDA and The Lancet : an exchange

Cited by 1 publication

References 1 publication

Safety, efficacy and costs of pharmacotherapy for functional gastrointestinal disorders: the case of alosetron and its implications

Safety, efficacy and costs of pharmacotherapy for functional gastrointestinal disorders: the case of alosetron and its implications

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