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AHA: Impotence May Be Early Warning Of Heart Disease
ATLANTA, GA -- November 10, 1999
VIAGRA DEATHS
Source: 8 June 1998 -- MedWatch Program
Food and Drug Administration
In response to Freedom of Information Requests, FDA is posting today these synopses of fatal outcome reports submitted to the FDA in which Viagra was a listed, associated drug. These present reports do not change FDA's perspectives on the safety of this drug as expressed in previous public talk papers. These synopses are being posted simply to make access to them easier for those in the general public who have expressed an interest in these reports.
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 has 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.
Case # 17 - #100-Total now over 100
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ATLANTA, GA -- November 10, 1999 -- Erectile dysfunction may be an early warning sign of heart disease, according to research being presented at the American Heart Association Scientific Sessions. Therefore, physicians should determine the cause of a man's erectile dysfunction and recommend additional evaluation in cases where it may be the result of diseased blood vessels, says the researcher.
Erectile dysfunction is defined as an inability to achieve or maintain an erection. "Erectile dysfunction could be called a 'penile stress test,' and may be another way for detecting diseased blood vessels in much the same way that the exercise stress test, which measures electrical signals from the heart, is used to detect diseased blood vessels of the heart," says Dr. Marc R. Pritzker, of the Minneapolis Heart Institute Foundation. "We now understand that atherosclerosis detected in one set of blood vessels markedly increases the chances of having this form of blood vessel disease in other areas of the body including the heart, brain, legs and kidneys. Because the blood vessels that supply the penis are narrower than arteries in other areas of the body, atherosclerosis -- the disease process that leads to heart attacks and strokes -- may manifest itself as erectile dysfunction before the disease becomes apparent in other arteries. This provides a wonderful opportunity for strong preventive programs that could reduce the risk of heart attacks and strokes," Pritzker says. Pritzker reviewed the histories and test results of 50 men with erectile dysfunction who had sought prescriptions for Viagra (a drug to treat impotence) and in turn were referred by their physicians for further evaluation. Although none of the men had symptoms of heart disease, 20 of them, or 40 percent, were found to have significant blockages in heart arteries which are associated with chest pain and an increased risk of heart attack. "Our population of patients was a very select group. We do not wish to suggest that heart disease is behind every case of erectile dysfunction. However, a man having regular sexual activity who experiences a consistent change in erectile function may be demonstrating signs of atherosclerosis where arteries become clogged and the heart muscle does not receive enough blood. As we become more thorough in our questioning of patients, it is not uncommon to hear that erectile dysfunction preceded the onset of heart disease by a year or more. Thus erectile dysfunction may be an early warning sign of the potential for heart problems." Pritzker adds that anywhere from 30 to 50 percent of cases of erectile dysfunction are the result of blood vessel disease. Other possible causes include use of prescription drugs such as heart or high blood pressure medications, pelvic injury, depression, drug dependency, degenerative diseases such as multiple sclerosis, and even fatigue and stress. Erectile dysfunction can also be the result of psychological factors, he says. "The experience to date with Viagra has shown it to be safe for patients with most forms of cardiovascular disease when the patients are appropriately counseled to avoid the use of nitroglycerin or nitroglycerin-like drugs and follow reasonable guidelines regarding physical exertion," Pritzker says. "The introduction of new treatments for erectile dysfunction offered options that were effective and easy. The openness that followed has significant public health implications," says Pritzker. "We now have another opportunity to look for heart disease, make a diagnosis, and offer appropriate prevention and, if necessary, treatment to men in an age group at risk for vascular disease, but who often don't visit a physician for routine check-ups. Only 15 of the 50 study participants had seen a physician within the two years before seeking treatment for erectile dysfunction. "The heart disease found in the study participants was treatable and, in many cases, the men's erectile dysfunction went away when they quit smoking or got their cholesterol levels under control," he says. None of the patients in Pritzker's study had symptoms of heart disease but 40 out of 50 had at least one risk factor for heart disease including cigarette smoking, elevated total cholesterol levels, high blood pressure, diabetes or a family history of heart disease. Treadmill exercise testing found signs of heart disease in 28 of the 50 men. Twenty of the men subsequently underwent angiography where a radioactive dye is injected into the heart arteries and then an X-ray is taken in order to detect blockages. Six of the 20 had blockages in all three major heart arteries, seven had two arteries that showed narrowing and one artery was blocked in the remaining seven men. The eight other men had positive exercise tests but further testing showed that either heart disease was not present or that angiography was not warranted for the minimal heart disease that was found. |