Is the sildenafil product information adequate to facilitate informed therapeutic decisions?

BACKGROUND: Optimal therapeutics and the prevention of adverse drug effects begin with complete information. When new drugs are released, the manufact urer's product information is the main and often only:readily available sou rce of drug information and, therefore, greatly influences treatment strate gies. Thus, it is vital that the information in the package insert is not o nly complete, but also as relevant as possible for the great diversity of p atients that physicians encounter. OBJECTIVE: To review the product information for sildenafil for comprehensi veness and accuracy,;with respect to whether the information is sufficient to facilitate optimal therapeutics and to prevent avoidable adverse events in the wide diversity of patients with erectile dysfunction seen in clinica l practice. DATA SOURCES: Sildenafil package inserts, unpublished information provided by the manufacturer, Food and Drug Administration reports. and articles ret rieved through MEDLINE through March 2000. DATA SYNTHESIS: Deficiencies or inaccuracies persist, in the sildenafil pro duct information regarding sildenafil's effects on blood pressure; potentia l drug interactions with cimetidine, protease inhibitors, some antihyperten sive drugs, alcohol, and drugs that may competitively inhibit cytochrome P4 50 pathways; and recommended sildenafil doses for older patients. CONCLUSIONS: For physicians to practice optimal therapeutics, adequate, cli nically relevant drug information is required. Several brief changes and ad ditions in the sildenafil product information would assist physicians in ma king therapeutic decisions regarding the use of sildenafil in a very divers e patient population and in avoiding preventable adverse events.