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Synopsis of Fatal Outcome Reports Submitted
to the FDA Regarding Viagra Use

In response to Freedom of Information Requests, the FDA has posted these synopses of fatal outcome reports submitted to the FDA in which Viagra was a listed, associated drug. These present reports do not change the FDA's perspectives on the safety of this drug as expressed in previous public talk papers.

In reviewing these reports, it is essential to remember the limitations associated with data derived from a spontaneous reporting system. In some of these cases, the reported clinical data was incomplete, and there is no way to determine that these drugs caused the reported reactions. Furthermore, a given reaction may actually have been due to an underlying disease process or to another coincidental factor.

Lastly accumulated case reports cannot be used to calculate incidence or estimates of drugs risk. The length of time a drug is marketed, the market share, size and sophistication of the sales force, publicity about an adverse reaction and regulatory actions are all factors that influence the probability that an event will even be reported. Comparisons of drug safety cannot be made from this data.

The numbers of reports in the adverse events database (AERS) may not be an accurate representation of the number of patients experiencing a reported adverse event. This is because there may be duplicate reports for the same patient, more than 1 reporter for the same patient or follow up reports on a previously reported case.

As of June 8, 1998, the FDA had received 16 unduplicated reports for Viagra in which there was a fatal outcome.

Case #1 -
A 63-year old man, on Glucotrol, allopurinol and aspirin therapy, had a history of Type II diabetes mellitus, hypercholesterolemia, hypertension and paroxysmal atrial fibrillation. Approximately one hour after taking medication and engaging in sexual activity, patient had a hemorrhagic stroke. Patient's condition deteriorated in the hospital, and he expired. Cause of death was not listed.
Case #2 -
A 62-year old man, on digoxin, insulin and blood pressure medication, had a history of diabetes mellitus, congestive heart failure, heart rhythm problems and some pulmonary fibrosis. Approximately half an hour to an hour after taking an initial dose of Viagra, without engaging in sexual activity, his head dropped and he was no longer breathing. Admitted to the emergency room with no respiration and no pulse. Resuscitation attempts were not successful. Cause of death was listed as myocardial infarct, congestive heart failure and hypertension.
Case #3 -
A 64-year old man, on Imdur therapy, had a history of cardiomyopathy, coronary artery disease, adult onset diabetes mellitus and possible history of angina. He took one dose of Viagra, engaged in sexual activity, and passed out. Resuscitation attempts were unsuccessful. The causes of death were listed as ventricular arrhythmia and myocardial ischemia.
Case #4 -
A 60- year old man, with unknown medical history and concomitant medications, expired after he was prescribed Viagra. It is not known if the patient took the medication. Cause of death was not listed.
Case #5 -
Reporter learned through the media of a patient who died while taking Viagra.
Case #6 -
A 73-year old man, on Hytrin, had a history of high blood pressure. After his second dose of Viagra, the patient collapsed during sexual activity. At the hospital he was found to have had a brain stem stroke and myocardial infarction. He did not regain consciousness and died. Cause of death was not listed.
Case #7 -
A 73-year old man, on no known concomitant therapy, had a history of previous MI. Subsequent to his use of Viagra, the patient was hospitalized with chest pain, hypotension and third degree block. Patient did not respond to resuscitative therapy, and he died a few hours after admission. No information given regarding sexual activity. Cause of death was not listed.
Case #8 -
A 48-year old man, for whom concomitant therapy is not known, had a history of diabetes. After taking Viagra, the patient had chest pains during sexual activity. He was given nitroglycerin in the ambulance. Chest pain subsided and the patient was stable for 30 minutes. Chest pain began again, and the patient went into cardiac arrest. He died in the emergency room. Cause of death was not listed.
Case # 9 -
Reporter learned through the media of a patient who took Viagra, experienced chest pain, and was treated with sublingual nitroglycerin. No information given regarding sexual activity. The patient subsequently died. Cause of death was not listed.
Case # 10 -
Reporter learned through the media of a patient who died while taking Viagra. No information given regarding sexual activity.
Case #11 -
A 74-year old man, on glyburide, Hytrin, Glucophage, and Cozaar therapy, had a history of type II diabetes mellitus, hypertension and malignant melanoma. Adverse event reported as sudden death in the morning after an evening dose of Viagra. No information given regarding sexual activity. Cause of death was identified as cardiopulmonary arrest.
Case #12 -
An 80-year old man, on Hytrin therapy, had a history of chronic atrial fibrillation and benign prostatic hypertrophy. Patient collapsed suddenly during sexual activity. Cause of death was not listed.
Case #13 -
A 57-year old man, with unknown concomitant drugs or medical history, took a dose of Viagra and engaged in sexual activity. Immediately after he experienced severe chest pain. He was given nitroglycerin. He expired in the emergency room. Cause of death was not listed.
Case #14 -
A 70-year old man, on Cardizem, Tenormin, and Synthroid, had a history of coronary artery disease, hypertension, and hypothyroidism. The patient used Viagra, and died at an unspecified date. No information given regarding sexual activity. Cause of death was not listed.
Case #15 -
A 67-year old man, on captopril, Pravachol, atenolol and aspirin, had a history of cardiac disease, hypertension, and hypercholesterolemia. Approximately one to one and a half hours after taking Viagra, and engaging in sexual activity, patient died. He turned gray color and had breathing problems. Patient was DOA at hospital. Cause of death was not listed.
Case # 16 -
Reporter learned of a 53-year old man, on insulin therapy, who died after recent use of Viagra. No information given regarding sexual activity. Cause of death was not listed.

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