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Lilly ICOS Announces FDA Approval of Cialis -- tadalafil -- A New Oral Treatment for Erectile Dysfunction |
"Cialis is an exciting new option for men with ED,"
said Dr. Francois Eid, Thus, Cialis joins Viagra and Levitra as alternative oral medications, all 3 now approved by the U.S. FDA, for ED. A comparison of the 3 is available here The safety and efficacy of Cialis was evaluated in 22
clinical trials in Phase III Cialis trial data were published recently in Urology, with accompanying editorials by USRF Director Leonard S. Marks, M.D. and Johns Hopkins professor Arthur L. Burnett, M.D. "Cialis is a new treatment option for erectile dysfunction that will be available for men in the United States," said Sidney Taurel, chairman and chief executive officer of Eli Lilly and Company. "Erectile dysfunction is a significant medical condition that affects millions of men in the U.S. Men tell us they want an ED treatment that will reduce the constraints of planning and allow them to choose the moment that is right for intimacy." "Cialis is now available in approximately 50 countries and has been used by more than one million men worldwide, " said Paul Clark, ICOS chairman and chief executive officer. "The early success of Cialis in other markets makes us confident that American men and their partners will appreciate this new treatment option." Safety Profile Cialis is not for everyone. Men taking any form of nitrates (often used to control anginal chest pain) should never take Cialis, as the combination may cause an unsafe drop in blood pressure. Men taking medicines called "alpha blockers" (sometimes prescribed for prostate problems or high blood pressure), with the exception of Flomax(R)(1)(tamsulosin HCl) 0.4 mg once-daily, should not take Cialis. This combination could also cause a significant drop in blood pressure. In clinical trials, the most common side effects with Cialis were headache, upset stomach, backache, and muscle ache. Most men weren't bothered by the side effects enough to stop taking Cialis. In placebo controlled Phase III clinical trials, discontinuation rates in patients treated with Cialis 10 mg or 20 mg was 3.1%, compared to 1.4% in placebo treated patients. Cialis is not recommended in patients who have suffered a heart attack or stroke within the last six months, or patients who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment, or retinitis pigmentosa (a rare eye disorder). Men should discuss their health status with their doctors to ensure that Cialis is right for them and that they are healthy enough to engage in sexual activity. Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV. About ED ED is defined as the consistent inability to attain and
maintain an
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