Viagra's bad side may top forecasts
Problems with the anti-impotence drug are exceeding expectations. Misuse may be the cause. By Marie McCullough and Michael Vitez INQUIRER STAFF WRITERS
The latest on Viagra may leave a lot of men feeling blue.
The new anti-impotence drug that's flying off the shelves is causing some users to see blue. And to have blurred vision and sensitivity to light.
And to have headaches, flushing and upset stomachs.
Worst of all, for an estimated 30 percent of users, Viagra is causing nothing.
"When the pill came out, I was elated," said Frank J. Mitros, 69, of Audubon, Pa. "I thought I could throw away the needles. This would be so easy, like taking an aspirin. I'm bitterly disappointed."
Those side effects of Viagra, made by Pfizer Inc., were predicted, but may be a bigger problem than anticipated because of misuse. Viagra was approved only for men who are diagnosed as impotent, but men seeking to boost their performance are also rushing to try it. Some are also experimenting with high doses. The potential for abuse, and uncertainties about long-term side effects, prompted the American Academy of Ophthalmology to warn men yesterday to watch out for visual disturbances, especially if they have eye problems such as macular degeneration or retinitis pigmentosa.
Drug labeling
Pfizer's studies found that, at recommended doses -- a pill of 25 mg to 100 mg once a day -- visual changes were mild, lasted only a few hours, and occurred in 3 percent to 11 percent of users. The drug labeling advises patients with retinitis pigmentosa to use Viagra "with caution."
But eye doctors are already hearing that the bluish tinge to vision may be happening more frequently at prescribed doses, and they're worried about patients taking higher doses, said Academy spokesman Michael F. Marmor, a Stanford University ophthalmologist.
"This is the sort of drug [ where ] men tend to think: 'If one pill is good, then let's see what I can do with four,' " Marmor said.
He conducted a study that showed a 200-mg dose of Viagra reduced retinal function by 30 percent to 50 percent for at least five hours.
Another concern, Marmor said, is whether the drug may cause cumulative or permanent changes in vision. "We need to do some studies about the long-term effects of taking Viagra," he said.
The U.S. Food and Drug Administration has not required Pfizer to conduct any further studies, but Viagra's warning labeling could be revised if new information about adverse effects becomes available, FDA spokeswoman Susan Cruzan said.
Upset stomachs
At doses up to 100 mg, Viagra's most common side effects were minor in studies: Seven percent got upset stomachs, 10 percent had flushing, and 7 percent got headaches. One area urologist said yesterday he hasn't received enough feedback yet to draw conclusions.
"I've heard from a handful," said Leigh Bergmann, attending urologist with Bryn Mawr Hospital. "Three said they were doing better, and two asked if they could increase the dose beyond FDA recommendations." James Barada, an Albany, N.Y., urologist and spokesman for the American Urological Association, said: "One patient left me a note. It says: 'It works. Gleefully, Jack.' The other guy gives me his sample of Viagra back and says it gave him the worst headache, that brought him to his knees, and didn't help him . . . . Are we meeting expectations? To some we are, and to some we aren't."
Mitros is in the latter camp.
He tried twice last week. Both nights, he resorted to a second pill. All he got was an upset stomach.
"My lady fiend and I went to her apartment, played some music, and got into the usual procedures and all," Mitros said. "And she said to me: 'I don't see anything happening.' And I said: 'I don't feel anything happening.' I was not going to waste the evening. One didn't work. Maybe I better try two. Twelve o'clock came, and nothing happened." Same thing the next night.
"I spent $275," he lamented. "With all the advertisement, all the publicity, I thought: 'Gee, what a wonderful thing.' I was willing to spend $275 for 30 pills. I thought it would be worth it." |