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FDA Approves 3rd Impotence Drug

Cialis joins Viagra and Levitra

FRIDAY, Nov. 21, 2003 (HealthDayNews) -- A third drug to treat male impotence has been approved by the U.S. Food and Drug Administration.

Eli Lilly's Cialis (tadalafil) joins Bayer's Levitra and the original anti-impotence drug, Pfizer's Viagra. The FDA says Cialis differs from competitors in that it stays in the body longer.

Impotence, or erectile dysfunction (ED), affects millions of men in the United States. Cialis acts by relaxing muscles and blood vessels in the penis, increasing blood flow and producing an erection.

The drug was tested among 4,000 men with ED, often caused by prostate surgery or illnesses like diabetes. The drug's effects are felt for up to 36 hours, and it remains in the body for as long as two days.

Cialis should not be used with nitrate-based drugs (nitroglycerin) or certain alpha blocker medications used to treat an enlarged prostate and high blood pressure. This combination could lower blood pressure enough to cause fainting and even death, the FDA says.

Patients with heart, kidney or liver disease should discuss these conditions with their doctors before using Cialis. People with an eye disorder known as retinitis pigmentosa should also be wary of using the drug, the FDA advises.

Most common side effects reported in the clinical trials included headache, indigestion, back pain, muscle aches, runny nose, and abnormal vision.

More information

To learn more about erectile dysfunction, visit the National Kidney and Urologic Diseases Information Clearinghouse and the National Library of Medicine's Medline Plus.

SOURCE: FDA Talk Paper, Nov. 21, 2003
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