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Titolo:
Comparison of FDA reports of patient deaths associated with sildenafil andwith injectable alprostadil
Autore:
Cohen, JS;
Indirizzi:
Univ Calif San Diego, Dept Family & Prevent Med, La Jolla, CA 92093 USA Univ Calif San Diego La Jolla CA USA 92093 nt Med, La Jolla, CA 92093 USA
Titolo Testata:
ANNALS OF PHARMACOTHERAPY
fascicolo: 3, volume: 35, anno: 2001,
pagine: 285 - 288
SICI:
1060-0280(200103)35:3<285:COFROP>2.0.ZU;2-O
Fonte:
ISI
Lingua:
ENG
Soggetto:
ERECTILE DYSFUNCTION; ORAL SILDENAFIL; CITRATE;
Keywords:
erectile dysfunction; sildenafil;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
10
Recensione:
Indirizzi per estratti:
Indirizzo: Cohen, JS 2658 Del Mar Hts Rd,Box 120, Del Mar, CA 92014 USA 2658 Del MarHts Rd,Box 120 Del Mar CA USA 92014 , CA 92014 USA
Citazione:
J.S. Cohen, "Comparison of FDA reports of patient deaths associated with sildenafil andwith injectable alprostadil", ANN PHARMAC, 35(3), 2001, pp. 285-288

Abstract

BACKGROUND: Sildenafil (Viagra) has been linked to 240 deaths (128 verified, 112 unverified) reported to the Food and Drug Administration (FDA) during 7.5 months of availability, and to 522 reported deaths after 13 months ofavailability. To date, no updated information about FDA-reported deaths has emerged, and no comparative analyses have been published. OBJECTIVE: To compare the mortality rates between sildenafil and injectable alprostadil, both of which are used exclusively for treating erectile dysfunction. METHODS: A comparison of the number of deaths per filled prescriptions reported to the FDA involving sildenafil and:injectable alprostadil was undertaken to perhaps provide further insight into this issue. Materials includedFDA statements on sildenafil adverse event reports to the FDA involving sildenafil and injectable alprostadil, and data on prescriptions filled for sildenafil and injectable alprostadil. RESULTS: The number of deaths per prescriptions filled reported in association with sildenafil was significantly greater (5.15-6.28 times) than in association with injectable alprostadil. DISCUSSION: Previous explanations for sildenafil-associated deaths have been based On the expected attrition within the population of men with erectile dysfunction and its commonly associated disorders, the physiologic stress of renewed sexual activity, and a pharmacologic effect of sildenafil. The results of this analysis may indicate that a pharmacologic effect of sildenafil is responsible for these deaths. However, other factors may also explain these findings. a greater frequency of reporting of sildenafil-associated events by physicians, a differencein the populations using these two drugs, or the number of prescriptions filled may not accurately reflect actual exposure. CONCLUSIONS: Further study should be undertaken to clarify the issues associated with sildenafil-related deaths. In the meantime reasonable precautions might be considered in prescribing sildenafil, such as initiating treatment with a low test dose of sildenafil.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 28/03/20 alle ore 23:34:06