Document Detail


Comparison of FDA reports of patient deaths associated with sildenafil and with injectable alprostadil.
MedLine Citation:
PMID:  11261524     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 of availability. 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 included FDA 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 sidenafil 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 difference in 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.
Authors:
J S Cohen
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  The Annals of pharmacotherapy     Volume:  35     ISSN:  1060-0280     ISO Abbreviation:  Ann Pharmacother     Publication Date:  2001 Mar 
Date Detail:
Created Date:  2001-03-22     Completed Date:  2001-06-21     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9203131     Medline TA:  Ann Pharmacother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  285-8     Citation Subset:  IM    
Affiliation:
Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, USA. jacohen@ucsd.edu
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MeSH Terms
Descriptor/Qualifier:
Alprostadil / administration & dosage,  adverse effects*
Erectile Dysfunction / complications*
Humans
Injections, Intravenous
Male
Mortality
Phosphodiesterase Inhibitors / administration & dosage,  adverse effects*
Piperazines / administration & dosage,  adverse effects*
Poisson Distribution
Purines
Sulfones
United States
United States Food and Drug Administration
Vasodilator Agents / administration & dosage,  adverse effects*
Chemical
Reg. No./Substance:
0/Phosphodiesterase Inhibitors; 0/Piperazines; 0/Purines; 0/Sulfones; 0/Vasodilator Agents; 139755-83-2/sildenafil; 745-65-3/Alprostadil
Comments/Corrections
Comment In:
Ann Pharmacother. 2001 Sep;35(9):1143   [PMID:  11573871 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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