A new pill for erectile dysfunction will be on the market in September. The new pill is called Levitra. Levitra's makers say a major plus is that it works quickly. In clinical trials, some men using Levitra achieved an erection in 16 minutes. Viagra's maker has responded with studies showing half of men taking Viagra were able to have sex within 20 minutes.
Comment: No denying that 4 minutes is 4 minutes.
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August 19, 2003 -- The Food and Drug Administration approved Levitra (vardenafil), an oral medication to treat erectile dysfunction in men (impotence). This is the second oral product approved for the treatment of erectile dysfunction. (Sildenafil, better known as Viagra, was the first.)
Erectile dysfunction affects millions of men in the United States. Levitra acts by relaxing muscles in the penis and blood vessels, allowing increased blood flow into the penis, which produces an erection.
Levitra was evaluated in randomized, placebo-controlled trials involving more than 2000 men with erectile dysfunction. In two of the trials men had erectile dysfunction associated with diabetes mellitus or following radical prostatectomy for prostate cancer.
The drug's effectiveness was assessed using a sexual function questionnaire. In addition, patients were asked to report if they were able to achieve an erection adequate for intercourse and whether the erection was maintained to allow completion of intercourse. In all of the trials, Levitra improved patients' ability to achieve and maintain a penile erection.
The recommended dose is 10 mg taken 1 hour before sexual activity. A higher dose of 20 mg is available for patients whose response to the 10 mg dose is not adequate. Two lower doses (2.5 mg and 5.0 mg) are also available and may be necessary for patients taking other medicines or having medical conditions that may decrease the body's ability to metabolize vardenafil (Levitra). Levitra should not be used more than once a day.
Levitra should not be used with nitrates (such as nitroglycerin tablets or patches) or with alpha-blockers (medicines that may be used to treat benign prostatic hyperplasia and/or high blood pressure such as tamsulosin, terazosin, doxazosin, and alfuzosin) because the combination of an alpha-blocker with Levitra may significantly lower the blood pressure and lead to fainting in some men. Currently, there is no information available to support the safety of even the lower doses of vardenafil taken together with alpha-blockers. In addition, Levitra should not be used in patients who have a rare heart condition known as "prolongation of the QT interval" because of the possibility of producing abnormal heart rhythm.
Because some drugs may affect the metabolism of Levitra, patients should inform their doctors that they are taking Levitra and they should not begin taking new medicines without informing their doctor. For example, patients taking erythromycin should not take more than a 5 mg dose of Levitra and a maximum dose of 2.5 mg Levitra once every 72 hours is the maximum recommended dose for patients who are taking the protease inhibitor ritonavir (Norvir) for HIV/AIDS.
Levitra should not be taken by men in whom sexual activity is inadvisable because of their underlying cardiovascular status (heart condition). Patients should inform their doctor about any heart problems they have experienced before taking Levitra.
Levitra 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, end stage renal disease requiring dialysis, or the eye disorder retinitis pigmentosa.
The most common side effects reported in clinical trials included headache, flushing, rhinitis (runny nose), and indigestion. Dizziness was reported in about 2% of patients. A small number of patients taking Levitra also reported abnormal vision.
Before taking Levitra, patients are advised to undergo a thorough medical history and physical examination to diagnose the underlying cause of the erectile dysfunction and to identify appropriate treatment.
Levitra confers no protection against AIDS or other sexually transmitted diseases.
Levitra is manufactured by Bayer Corporation in Germany and will be distributed by Glaxo Smith Kline. The drug is currently available in Europe.
Based on FDA Talk Paper #T03-63, August 19, 2003 (www.fda.gov)