As Uprima, an alternative to Viagra that helps men with erectile disfunction, inches closer towards Food and Drug Administration approval, there is a growing chorus of opposition that says the drug is too dangerous.
On its Web page, the maker of Uprima says the drug will offer men "a promising new option."
But it may inspire more sickness than romance, according to some medical experts.
CBS News Correspondent Sharyl Attkisson reports a full 20 percent of the men in one study were nauseated by Uprima. That's not surprising, perhaps, since it's made with the same medicine doctors once used to induce vomiting in children who swallowed poison.
Dr. Sidney Wolfe, of the consumer watchdog group Public Citizen, says there are more serious concerns.
He says, "Whereas nausea and vomiting may be unpleasant and not too compatible with having good sex, having your blood pressure go dangerously low, fainting unpredictably -- for instance when you're driving a car -- can be life threatening."
In one study, a man did pass out while driving after taking Uprima and caused a car accident. Another fainted and fractured his skull.
Others collapsed and required IV fluids, oxygen, and even hospitalization.
These side effects took place even though the men studied were the healthiest ever used to test this kind of drug, leading one FDA scientist to predict in internal documents that problems in the general public may be much worse.
One of the biggest concerns to critics is that men are advised to avoid alcohol before a Uprima interlude, or risk severe side effects.
The drug's lead FDA reviewer wrote that "may not be practical...in a real-world situation."
Wolfe says, "In the real world people are going to be drinking at the time that they are romanticizing and getting ready for having some kind of sex."
The FDA Advisory Committee noted many of those concerns, but agreed with the drugmaker that correct labeling and warnings would be enough to protect patients. A final decision on Uprima's approval will come by the end of the month.
The drugmaker is Illinois-based TAP Pharmaceuticals, a joint venture between Abbott Laboratories and Takeda Pharmaceuticals, a unit of Takeda Chemical Industries.
Pfizer Inc. makes rival Viagra, a blockbuster pill with sales of more than $1 billion last year.
In TAP's clinical trials of 1,900 patients, 0.6 percent of patients taking two and four milligram doses of Uprima fainted, a company spokeswoman says. TAP is asking for approval for the two milligram dose, which had the lowest rate of side effects.
"We're confident in Uprima and we were encouraged by the positive recommendation we got from the advisory panel," says TAP spokeswoman Kim Modory.
TAP has given the FDA new information on Uprima's safety that was not available when the advisory panel met, Modory added.
Uprima works by stimulating production of the brain chemical dopamine, which sends a signal for an erecton. Viagra, which increases blood flow to the penis, can be dangerous when combined with heart drugs known as nitrates.
An FDA spokeswoman said the agency would consider Public Citizen's letter on Uprima. "We will take it under consideration and review it," the spokeswoman said.
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