WASHINGTON — U. S. health regulators are considering a new drug for impotence, the biggest issue in the world since the death of drug maker Eli Lilly and Company in 2003.
The Food and Drug Administration says it has found the impotence drug Viagra to have caused more than 20,000 cases of sexual dysfunction in patients over 60 years old.
Viagra, the brand name for Sildenafil, is a drug for impotence that was approved in 1999 by the Food and Drug Administration. The drug also was approved in 2003 by the Food and Drug Administration for the treatment of pulmonary arterial hypertension.
The FDA says it has found the impotence drug, which also is sold under the brand name Revatio, had an average of three reported cases in 2000, with an average of 10 cases in 2000.
The number of cases of sexual dysfunction is higher in older patients than in younger patients, the agency said. The number of cases of sexual dysfunction for women is higher than for men, it said.
The agency said Viagra was the most recent Viagra drug, which is sold under the brand name Revatio.
The FDA also said the FDA is studying a number of other impotence drugs, including another drug called Avandamet, and an impotence drug called Zimax.
The FDA has asked the makers of Viagra, Cialis, Levitra and Stendra to produce a list of all the drugs they are considering, including those that are sold under the brand name Revatio.
The FDA said that an advisory panel recommended the drug, which is marketed as "Viagra", be withdrawn from the market by the end of this year.
The FDA said it has not received any reports of sexual dysfunction in patients who took the drug or in patients who had taken the drug before, and it said it is not making any recommendations on the safety of the drug for those patients.
It has also said the drug has not been shown to cause an adverse reaction in patients who took Viagra or those who had taken Viagra with other drugs.
The drug maker Pfizer said it has made a decision to halt its marketing of the drug in favor of Viagra.
"We have made our decision to withdraw Viagra from the market," the company said in a statement.
The FDA said it has no plans to change its stance on Viagra or any other drug for impotence.
In June, the FDA ordered manufacturers to stop marketing Viagra, Viagra Connect and other generic versions of the drug that were sold under the brand name Revatio.
But last month, FDA officials said they have received reports of sexual dysfunction in patients who took Viagra or another drug, including one case of sexual dysfunction.
Since the drugmaker began marketing its own generic version, known as Revatio, in 2004, it has taken steps to address sexual side effects associated with the drug.
Viagra has been linked to a higher than expected sexual side effect rate in men over the age of 50, a condition that affects millions of men worldwide. Viagra and other drugs for this purpose are approved by the Food and Drug Administration for the treatment of this condition.
It is estimated that the prevalence of sexual dysfunction in the United States is 2.5 percent, or nearly 30,000 men.
For the drug industry, the problem is growing.
The pharmaceutical industry has spent $2.7 billion on research and development for Viagra, according to IMS Health. The drug is the most expensive drug in the U. S., with sales of $1.3 billion.
In a statement to the New York Times, Pfizer said the company is reviewing its decision, noting that the company has not received any reports of sexual dysfunction in patients who took the drug or in patients who had taken the drug before, and it is not making any recommendations on the safety of the drug for those patients.
The company also said it will continue to market and sell the drug without requiring patients to take a medical condition known as contraindications, the drug's label said.
The FDA said that Viagra's effectiveness in treating impotence has been the subject of ongoing clinical trials, and it has not received any reports of sexual side effects in patients who took the drug or in patients who had taken the drug before, and it is not making any recommendations on the safety of the drug for those patients.
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