Comparison of FDA reports of patient deaths associated with sildenafil andwith injectable alprostadil

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 dysf unction. METHODS: A comparison of the number of deaths per filled prescriptions repo rted to the FDA involving sildenafil and:injectable alprostadil was underta ken to perhaps provide further insight into this issue. Materials included FDA statements on sildenafil adverse event reports to the FDA involving sil denafil and injectable alprostadil, and data on prescriptions filled for si ldenafil and injectable alprostadil. RESULTS: The number of deaths per prescriptions filled reported in associat ion with sildenafil was significantly greater (5.15-6.28 times) than in ass ociation with injectable alprostadil. DISCUSSION: Previous explanations for sildenafil-associated deaths have been based On the expected attrition wit hin the population of men with erectile dysfunction and its commonly associ ated disorders, the physiologic stress of renewed sexual activity, and a ph armacologic 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 frequenc y of reporting of sildenafil-associated events by physicians, a difference in the populations using these two drugs, or the number of prescriptions fi lled may not accurately reflect actual exposure. CONCLUSIONS: Further study should be undertaken to clarify the issues assoc iated with sildenafil-related deaths. In the meantime reasonable precaution s might be considered in prescribing sildenafil, such as initiating treatme nt with a low test dose of sildenafil.