THURSDAY, May 24, 2007 (HealthDay News) -- The U.S. Food and Drug Administration has approved Tindamax (tinidazole) to treat bacterial vaginosis (BV), the most common vaginal infection among women of childbearing age, drug maker Mission Pharmacal said Thursday.
It's the first new oral therapy in a decade to treat BV, which affects almost one-third of women in the United States, the company said. Caused by an overgrowth of certain bacteria, BV often does not have symptoms. When they are present, symptoms may include vaginal discharge, burning during urination, and itching.
Tindamax treats the entire reproductive tract, including the upper tract where the bacteria have been shown to migrate. Left untreated, BV can increase a woman's risk of acquiring sexually transmitted diseases including chlamydia, gonorrhea and HIV, the drug maker said. Among pregnant women, BV can increase a woman's risk of early pregnancy loss and premature delivery.
During clinical testing, side effects of Tindamax included metallic taste and nausea. First FDA approved in 2004, the drug was previously sanctioned for trichomoniasis, giardiasis, and amebic liver abscess.
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