FDA panel backs new impotence pill despite worry over risks

BETHESDA, Md. -- A drug called Uprima is poised to give the famous blue impotence pill Viagra its first competition: Government advisers say it works well enough that it should be allowed to sell as long as men are warned that it has some dangerous side effects.

Unlike Viagra, which eases impotence by increasing blood flow to the penis, Uprima works in the brain.

Advisers to the Food and Drug Administration recommended on a 9-3 vote Monday that it helps enough men regain erections that it should be sold -- as long as patients and their doctors understand it causes worrisome problems and isn't for everyone.

One in every 30 men who tested Uprima's optimal dose fainted or suffered seriously low blood pressure. A few fell and hit their heads, one fracturing his skull. Another crashed his car.

''There will be some people who will probably lose their lives because they pass out at the top of stairs or are operating a car'' when they faint, warned FDA adviser and Philadelphia cardiologist Dr. Peter Kowey.

''This drug is clearly going to kill some people,'' agreed Dr. Robert Califf of Duke University, worried about heart patients taking other medicines that lower blood pressure. He also advised FDA to label Uprima with warnings against drinking alcohol while taking Uprima, saying even a few drinks may increase the risk.

Both Kowey and Califf joined the majority in recommending the drug. The FDA is not bound by its advisers' decisions.