WASHINGTON — The Food and Drug Administration is adding serious new health warnings to the label on bottles of Viagra, the wildly popular anti-impotence drug that has been prescribed for 3 million men since it was approved for general use in April.
In expanded labels, the government warns doctors and patients that men with heart problems and very high or very low blood pressure should be carefully examined before getting a prescription for Viagra.
Patients with retinitis pigmentosa, an eye disease, also are at risk. And the new description warns about the rare occurrence of priapism, a dangerous condition involving painful, prolonged erections that can last more than four hours.
The government still considers Viagra safe and effective, the FDA said Tuesday. But it is sending a letter to doctors as well as expanding the information printed on the labels by Pfizer, the drug manufacturer.
Of the 130 deaths reported to the FDA among men taking the drug, none has been directly blamed on the drug. Instead, the FDA believes that many of those who died--whose average age was 64--had serious health problems that were aggravated by sexual activity, resulting in heart attacks or strokes.
"The people who died had underlying cardiovascular problems." said Dr. Lisa Rarick, director of the FDA division of reproductive and urologic drug products.
She added that the FDA is advising patients with serious heart problems to discuss with their doctors, "Is sex a good idea for me?"
Many men with heart disease may be impotent because of their medical condition. And the FDA is now emphasizing that sex for these patients "carries a potential cardiac risk."
If sex itself might be risky because of a patient's health problems, then impotence treatments such as Viagra should be avoided, the FDA said in its three-page announcement of the expanded warnings.
Viagra is prescribed for men who are unable to have erections. More than 6 million prescriptions have been written for 3 million men in the United States.
Currently, the Viagra label warns that the drug should not be used by people taking heart medicine containing nitrates. The combination of nitrates and Viagra can cause a dangerous, sometimes life-threatening drop in blood pressure.
The new label will advise that Viagra be prescribed with caution in patients who:
* Had a heart attack, stroke, or a "life-threatening arrhythmia (irregular heart beat) in the last six months."
