Viagra label warnings strengthened due to deaths

Patient types excluded from trials listed

The number of U.S. patient deaths associated with the use of Pfizer’s Viagra (Sildenafil) between March and mid-November 1998 now totals 128, according to the U.S. Food and Drug Administration. Based on that number and the range of the causes of death, extensive additions have been added as label warnings.

Seventy-seven of the deaths were due to cardiovascular events (41 from myocardial infarction, 27 from cardiac arrest, six with cardiac symptoms, and three based on coronary artery disease), while the cause of death was unclear in 48 cases. The average age was 64, and doses ranged from 25 mg to 100 mg. Forty-four patients died or showed symptoms leading to their cause of death within four to five hours of ingestion. Twenty-seven died during or immediately after intercourse. Between April 1998, when the drug was approved, and mid-November, more than 6 million outpatient prescriptions have been dispensed, representing some 50 million doses. (All figures are from the FDA and its MedWatch program.)

The new warning labels are listed by category:

1. Post-marketing cardiovascular events. These labels address reports of heart attack, sudden cardiac deaths, and hypertension.

2. Risks of sexual activity. These labels provide cautions against use for patients with pre-existing cardiovascular disease.

3. Vasodilatory effects. These caution use in patients susceptible to sudden or lengthy drops in blood pressure.

Other warning labels provide:

o cautions for patients with conditions not included in clinical trials, such as those who have suffered a heart attack, stroke, or severe arrhythmia in the last six months, those with high or low blood pressure, those with a history of cardiac or coronary conditions causing unstable angina, and those with retinitis pigmentosa or other eye disorders;

o cautions prompting that medical attention is necessary for patients suffering from priapism for more than four hours.

In addition to the new label warnings, the American College of Cardiology and the American Heart Association have issued interim recommendations on patient risks much like the new labeling, while reiterating strong contraindications of Viagra use for patients taking nitrates.

The recommendations also warn against prescribing the drug for patients taking combination hypertensive regimens and for patients who may experience prolonged half-life effects of the drug, particularly those with renal or hepatic disease or those taking erythromycin or cimetidine.

The FDA is making available a summary of the patient deaths associated with the drug.

For more details, call Pfizer Inc. at (800) 438-1985 or the FDA’s MedWatch program at (800) FDA-1088.