Friday, April 25, 2008

FDA Approves Tadalafil for the Treatment of ED

United States Food and Drug Administration (FDA) has approved generic Cialis, a new oral PDE5 inhibitor, for the treatment of sexual dysfunction (ED). Cialis was shown to improve sexual dysfunction compared to placebo up to 36 hours following dosing. In lab studies, the ability to have sexual activity was increased in some patients at 30 minutes after having a dosage.

Thus, tadalafil joins Sildenafil and Vardenafil HCI as alternative oral pills, all 3 now approved by the U.S. Food & Drug Administration, for erectile dysfunction.

Cialis is not for everybody. Men taking any form of nitrates (often used to control certain chest pain) should not take tadalafil, as the combination could cause an unsafe drop in blood pressure. Men taking pills called "alpha blockers" (sometimes prescribed for prostate problems or high blood pressure) should not take tadalafil. This combination may also cause a significant reduction in blood pressure.

The safety and efficacy of Cialis was evaluated in twenty two clinical trials in more than 4,000 patients. Cialis was shown to be effective in treating impotance in patients 27 to 87 years old, including patients with other underlying medical symptoms. In 2 of these clinical trials, men had impotance associated with diabetes or following radical prostatectomy for prostate cancer.

In clinical studies, the most common side effects with generic Cialis were headache, upset stomach, backache, and muscle ache. Most men weren't bothered by the side effects enough to stop taking generic Cialis. In placebo controlled Phase III clinical studies, discontinuation rates in patients treated with generic Cialis 10 mg or 20 mg was 3.1%, compared to 1.4% in placebo treated patients. Generic 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 physicians to ensure that generic Cialis is right for them and that they are healthy enough to engage in sexual activity. Generic Cialis does not protect a man or his partner from STD, including HIV.