Consumer Group Urges FDA
To Reject Alternative to Viagra

WASHINGTON -- A consumer group is urging federal health officials to prevent a new impotence drug from entering the U.S. market because of safety concerns.

Uprima, a TAP Pharmaceuticals Inc. drug that has been touted as an alternative to Viagra, likely will cause serious health problems and even deaths if it is approved by the Food and Drug Administration, said Public Citizen. In a letter to Janet Woodcock, director of the FDA office in charge of drug reviews, the Washington group said approving Uprima would be a "serious mistake, adding to the toll of people injured or killed by drugs that should never have been approved."

The group pointed to clinical trials conducted by TAP, in which blood pressure dropped in 3% to 6% of the men who took a 4-mg dose of Uprima, while 1% to 2% experienced fainting. Higher doses, which many patients took in an open-dose trial, were associated with more side effects, Public Citizen said. In one case, a 33-year-old man who took a 4-mg dose crashed his car after losing consciousness. A 42-year-old man fell and fractured his skull after taking a 5-mg dose.

If Uprima wins FDA approval, "it will take no more than three or four months before a further group of accidents happens," said Sidney Wolfe, director of Public Citizen.

The letter also said labeling that warns against consuming alcohol with Uprima, as suggested by an FDA advisory committee that reviewed the drug, likely would be disregarded in many cases. In clinical studies, alcohol doubled or tripled the occurrence of Uprima's side effects, especially dizziness, pallor and low blood pressure, the letter said.

TAP spokeswoman Kim Modory said the company, a joint venture between Abbott Laboratories of Abbott Park, Ill., and Takeda Chemical Industries Ltd., of Osaka, Japan, remains confident in the drug and expects a response soon from the FDA. TAP has said Uprima, known generically as apomorphine, is an important alternative for men who don't respond to Pfizer Inc.'s Viagra, the first oral treatment for impotence approved by the FDA.

Viagra also has been associated with drops in blood pressure, as well as harmful interactions with certain heart medications. Sales of the drug, which was approved by the FDA in 1998, totaL about $1 billion annually. Dr. Wolfe said the safety risks for Uprima are "much more significant" than those with Viagra.

Uprima, which targets mechanisms in the brain to cause an erection, works after about 15 minutes, compared with the hour needed for Viagra, TAP told an FDA advisory panel that reviewed the drug in April. At that meeting, panelists voted in favor of 2-mg and 4-mg doses of Uprima, while voicing concerns about its side effects. "This drug is clearly going to kill some people," panelist Robert Califf of Duke University said at the meeting. He voted for approval but recommended that patients get leaflets that explain the drug's risks.

Panelist Leonore Tiefer of the Yeshiva University's Albert Einstein College of Medicine in New York said she voted against both doses because more data were needed about Uprima's interaction with other drugs and the effects it might have on people with other diseases. Ms. Tiefer said she was surprised by the panel's 9-3 vote that the 4-mg dose's risk-benefit ratio is acceptable. "There is a substantial number of people who could be endangered" by Uprima, she said Monday. "Why do we need to be in such a hurry?"

Though the panel's recommendations aren't binding, the FDA typically agrees with its committees' votes. An FDA spokeswoman said the agency hasn't made a decision about the drug and would take Public Citizen's letter into consideration.