Vandazole and Pregnancy

The prescription drug Vandazole (metronidazole vaginal gel) is specifically approved for use in women who are not pregnant. There are some concerns that using metronidazole products like Vandazole during pregnancy may be associated with a risk for childhood or adult cancer. In many cases, there may be oral medications that are better choices for treating bacterial vaginosis in pregnant women.

Can Pregnant Women Use Vandazole?

Vandazole® (metronidazole vaginal gel) is a prescription medication used for the treatment of bacterial vaginosis (BV). Specifically, this drug is approved only for use in women who are not pregnant. Even though metronidazole (the active ingredient) is a pregnancy Category B medication, it is unclear whether this product is completely safe for use during pregnancy.
There is some concern about the carcinogenic (cancer-causing) potential of metronidazole products, including Vandazole, when used during pregnancy. However, because bacterial vaginosis is a risk factor for some serious problems during pregnancy, the potential risks of the drug will likely be outweighed by the benefits.

What Is Pregnancy Category B?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies.
Metronidazole, the active ingredient in Vandazole, crosses the placenta. In general, animal studies have failed to show that metronidazole causes problems during pregnancy; however, one study suggested that metronidazole injected into the abdominal (stomach) cavity might cause miscarriages. Surveys and other similar types of studies in humans seem to suggest that metronidazole probably does not cause birth defects.
There is some concern that exposure to metronidazole during pregnancy might increase the risk of childhood or even adult cancers. Metronidazole increases the risk of certain cancers in mice and rats; it is unknown if the same is true for humans. Studies have failed to consistently show that metronidazole exposure does or does not increase the risk of childhood cancers.
More importantly, however, bacterial vaginosis is a risk factor for preterm delivery and low birth weights. This means that it is especially important to treat bacterial vaginosis in pregnant women. So, in many situations, the risks of the drug are probably outweighed by the potential benefits.
However, in many cases, oral antibiotics like oral metronidazole are preferred for use during pregnancy to make sure the condition is effectively treated. An oral antibiotic is usually more effective in cases where the condition has affected upper parts of the genital tract that would not necessarily be effectively treated with a vaginal gel like Vandazole.

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Last reviewed by: Kristi Monson, PharmD
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