Fenfluramines strongly associated with AR, MR, TR and valve surgery

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Fenfluramines strongly associated with AR, MR, TR and valve surgery Researchers from the US have conducted the largest study of the duration of exposure to fenfluramines* and the first to estimate the incidence of consequent valvular surgery. Their observational study evaluated data from 5743 fenfluramine users who underwent echocardiography between July 1997 and February 2004 at the Utah Valley Regional Medical Center in Provo, US. Overall, 7457 echocardiograms were completed, and the duration of fenfluramine use was available from 4519 individuals. Mild or greater aortic regurgitation (AR) or moderate or greater mitral regurgitation (MR) was observed in 18.4% of patients; the prevalence was 19.6 % in women and 11.8% in men (p < 0.0001). Mild or greater AR and MR at baseline were both significantly associated with age, female gender, duration of fenfluramine use and time elapsed between the date fenfluramine was removed from the market and the date the scan was performed. 1020 patients had repeat scans, with a mean period of 30.3 months between scans. During this period, AR increased in 15.4%, was stable in 63.1% and improved in 21.5%, and the corresponding values for MR were 24.8%, 47.6% and 27.6%, respectively. Over the 6.5 years of follow-up, heart valve surgery was undertaken in 38 patients, of whom 25 had evidence of fenfluramine-related valvular disorders. The researchers noted that "valvular requiring surgery, while not common in absolute terms, was substantially increased above expected rates and may continue to be seen by clinicians well into the future". * The manufacturers of fenfluramine and dexfenfluramine were asked to withdraw these products from the market by the US FDA in 1997. Dahl CF, et al. Valvular regurgitation and surgery associated with fenfluramine use: an analysis of 5743 individuals. BMC Medicine 6: Online first [33 pages], No. 801075422 34, 6 Nov 2008. Available from: URL: http://www.biomedcentral.com

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Reactions 29 Nov 2008 No. 1230