On Sildenafil Citrate.
From the marketing on Sildenafil Citrate (Viagra) in late March through mid-November 1998, during which more than 6 million outpatient prescriptions (representing about 50 million tablets) were dispensed, the FDA received reports of 130 U.S. patients who died after having been prescribed this drug. Excluded were reports of 55 foreign patients, 35 with unverifiable information (from hearsay, rumor, the media, or unidentifiable reporters), and 22 with unconfirmed Viagra use.
Of the 130 U.S. patients, two men died from homicide and drowning; three had strokes; and 77 had cardiovascular events (41 with definite or suspected myocardial infarction, 27 with cardiac arrest, 6 with cardiac symptoms, and 3 with coronary artery disease). Cause of death was unmentioned or unknown for 48. All with gender specified were men. Age was provided for 104 individuals whose average age was 64 years (median = 64, range = 29-87). Of 62 with Viagra dose reported, 3 had taken 25 mg; 46, 50 mg; 9, 100 mg; 2, 50-100 mg.; 1, more than 100 mg (exact dose unknown); and 1, an overdose. Sixteen men took or were administered nitroglycerin or a nitrate medication that is contraindicated with the use on Sildenafil Citrate. In addition, three men were found with nitroglycerin in their possession, but it is not known if it was taken.
Time from use on Sildenafil Citrate to death or onset of symptoms leading to death was examined since the drug is taken periodically and since a direct effect of the drug would be limited to a finite period after drug ingestion. Excluding the two men who died from homicide and drowning, 44 (34%) of the 128 patients died or had onset of symptoms leading to death within 4 to 5 hours on Sildenafil Citrate use (including 27 during or immediately after sexual intercourse). Six died or developed symptoms later the same day; 8, the next day; 5, two days later; and 4, three to seven days after Viagra use. The time from drug ingestion to death or onset of symptoms leading to death was not stated or was unknown for 61 men (48%).
Ninety (70%) of the 128 patients had one or more risk factors reported for cardiovascular or cerebrovascular disease (hypertension, hypercholesterolemia, cigarette smoking, diabetes mellitus, obesity, previous cardiac history). Three additional persons without identified heart disease or risk factors had severe coronary artery disease detected at autopsy. Twelve were reported to have no previous history of cardiac disease or risk factors, but for 10 of these, the time from last Viagra use to death or onset of symptoms leading to death was unknown or was at least two days later. Two men, 60 and 70 years old, had no mentioned risk factors, no sexual activity, and died shortly after Viagra ingestion.
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