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 manufacturer's product information is the main and often only readily available source of drug information and, therefore, greatly influences treatment strategies. Thus, it is vital that the information in the package insert is not only complete, but also as relevant as possible for the great diversity of patients that physicians encounter.


OBJECTIVE
To review the product information for sildenafil for comprehensiveness 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 clinical practice.


METHODS
Sildenafil package inserts, unpublished information provided by the manufacturer, Food and Drug Administration reports, and articles retrieved through MEDLINE through March 2000.


RESULTS
Deficiencies or inaccuracies persist in the sildenafil product information regarding sildenafil's effects on blood pressure; potential drug interactions with cimetidine, protease inhibitors, some antihypertensive drugs, alcohol, and drugs that may competitively inhibit cytochrome P450 pathways; and recommended sildenafil doses for older patients.


CONCLUSIONS
For physicians to practice optimal therapeutics, adequate, clinically relevant drug information is required. Several brief changes and additions in the sildenafil product information would assist physicians in making therapeutic decisions regarding the use of sildenafil in a very diverse patient population and in avoiding preventable adverse events.
Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, USA. jacohen@ucsd.edu
J S
JS
Cohen
D000368:Aged; D004347:Drug Interactions; D007172:Erectile Dysfunction / Q000150:complications*; D006801:Humans; D007255:Information Services; D008297:Male; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects*; D011687:Purines; D000068677:Sildenafil Citrate; D013450:Sulfones
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate