WEDNESDAY, Aug. 20, 2003 (HealthDayNews) -- The new erectile dysfunction drug Levitra (vardenafil) won approval from the U.S. Food and Drug Administration late Tuesday, making it the first approved medication to compete with Viagra.
Like Viagra, Levitra acts by relaxing blood vessels and muscles in the penis, improving blood flow and aiding an erection. The new drug was evaluated during clinical trials involving more than 2000 men with erectile dysfunction, including those who suffered from diabetes mellitus and prostate cancer -- both major causes of impotence.
Trial participants who took Levitra, on average, were five times more likely to achieve a satisfactory erection than those who took a non-medicinal placebo.
The medication is meant to be taken an hour before sexual activity. It should not be taken with nitroglycerin tablets and other nitrates, and should not be used by men who take so-called alpha-blockers to treat an enlarged prostate or high blood pressure. And men with heart conditions are strongly urged to advise their doctors before taking Levitra, the FDA warns.
Side effects reported during clinical trials include headache, stuffy nose, dizziness, indigestion, and abnormal vision. Levitra is produced by Bayer AG and distributed in the United States by GlaxoSmithKline. It was recently made available in Europe.
Here is the FDA Talk Paper about Levitra. For more information about erectile dysfunction, visit National Kidney and Urologic Diseases Information Clearinghouse.