BR, Randy & all, here's the FDA Postmarketing Safety of Sildenafil Citrate (Viagra) report. Date of report 22-Jul-1998 12:44:48 pm, date published on FDA site Aug 24, 1998. No alients/extraterrestrials mentioned. No need to involve Mulder and Scully, at least not yet...or perhaps there's a conspiracy out there..???
Postmarketing Safety of Sildenafil Citrate (Viagra)
In response to Freedom of Information requests, the FDA is posting a summary of reports of death in sildenafil citrate (Viagra) users. This posting does not suggest a change in FDA's perspective concerning the safety of Viagra. The intent is simply to provide easier access for those who have requested this information.
The limitations of spontaneous postmarketing adverse drug event data should be considered when interpreting these data:
Reports are submitted voluntarily, and the magnitude of
underreporting is unknown. Some of the factors that may influence
whether an event is reported include: awareness by health
professionals and consumers of adverse drug event reporting,
seriousness of the reaction, market share of the drug, length of time
since marketing, publicity about a drug or an adverse event,
litigation, and regulatory actions.
Because of underreporting and uncertainty concerning the number
of persons exposed to a drug, it is not possible to calculate a true
incidence rate of a particular event for a specified drug.
In some reports, clinical information (such as medical history,
validation of diagnosis, time from drug use to onset of illness, dose,
and use of concomitant drugs) is missing or incomplete. Follow-up
information may not be available.
An accumulation of adverse event reports does not necessarily
indicate that the adverse event was caused by the drug; rather, the
event may be due to an underlying disease or some other factor(s).
The reports summarized below have been reviewed to eliminate
duplicates. Numbers of reports from a computerized listing of the
Adverse Event Reporting System (AERS) should therefore not be
expected to match the numbers below, as those listings also
contain duplicate reports and reports that are little more than
hearsay.
Summary of Reports of Death in Viagra Users Received
from Marketing (late March) through July 1998
From the marketing of sildenafil citrate (Viagra) in late March through July 1998, during which more than 3.6 million outpatient prescriptions were dispensed, the FDA received reports of 123 patients who died after having been prescribed this drug. Twelve deaths concerned foreign patients and 30 concerned patients with unverifiable information (from hearsay, rumor, the media, or unidentifiable reporters). In addition, reporters stated that they did not know if the drug had been used for 12, leaving 69 U.S. patients who died after having taken Viagra. Of these, cause of death was unmentioned or unknown for 21, two patients had strokes, and 46 had cardiovascular events (21 with definite or suspected myocardial infarction, 17 with cardiac arrest, 4 with cardiac symptoms, 3 with coronary artery disease, and one with severe hypotension leading to cardiac arrest).
Of the 69 U.S. patients, 66 with gender specified were men. Age was provided for 55 individuals whose average age was 64 years (median = 64, range = 29-87). Of 31 with dose reported, 26 had taken the 50 mg dose, 3 had taken the 100 mg dose, and 2 were prescribed 50-100 mg. Twelve men self-medicated or were administered nitroglycerin or a nitrate medication that is contraindicated with the use of Viagra.
Time from use of Viagra 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. Twenty-five (36%) of the 69 patients died or had onset of symptoms leading to death within 4 to 5 hours of drug use (including 18 during or immediately after sexual intercourse). Three died or developed symptoms later the same day of Viagra use; 7, the next day; 4, two days later; and 2, three to four 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 28 men (41%).
Fifty-one (74%) of the 69 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. Five were reported to have no previous history of cardiac disease or risk factors.
As with all approved medications, the FDA will continue to monitor the postmarketing safety of Viagra by carefully reviewing reports of death and other serious adverse events and will continue to evaluate the need for regulatory action.
Back to Viagra Information Page
August 24, 1998
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