-- Robert Preidt
WEDNESDAY, Aug. 3 (HealthDay News) -- Pregnant women who take
ongoing, high doses of the drug fluconazole (brand name Diflucan)
may be at increased risk of having babies with birth defects, the
U.S. Food and Drug Administration warned Wednesday.
The drug is used to treat yeast infections of the vagina, mouth,
throat, esophagus and other organs. It's also used to treat
meningitis caused by a certain type of fungus and to prevent yeast
infections in patients undergoing chemotherapy or radiation therapy
prior to a bone marrow transplant.
The FDA said chronic, high doses (400 to 800 milligrams per day)
of fluconazole during the first trimester of pregnancy may increase
the risk of a rare and distinct set of birth defects.
There doesn't appear to be any increased risk with a single, low
dose (150 mg) to treat vaginal yeast infection.
One expert agreed that the move shouldn't affect most women.
"Diflucan is generally reserved for resistant genital infections and when used for this indication the lower dose regimen is used," said Dr. Edwin R. Guzman, professor in the department of obstetrics and gynecology and director of maternal-fetal medicine at NYU Langone Medical Center, New York City. "It is generally used for non-genital tract/systemic infections and in patients who are immunocompromised. Therefore, long-term high dose use in pregnancy would not be a common occurrence."
He said that if a woman was prescribed the drug during
pregnancy, "it would be in unique situations where the benefits
would have to be carefully weighed against the fetal risks."
Based on the available information, the FDA has changed the
pregnancy category for extended, high-dose fluconazole use (other
than vaginal yeast infection) from category C to category D.
Pregnancy category D means there is evidence that this use of
the drug poses a risk to human fetuses, but may still be acceptable
due to the potential benefits from use in pregnant women with
serious or life-threatening conditions, the FDA said.
The pregnancy category for a single, low-dose of fluconazole was
not changed and remains category C.
Women who use fluconazole during pregnancy should be informed of
the potential risks to the fetus, and women who are or become
pregnant while taking the drug should notify their health care
providers, the FDA said.
The U.S. Centers for Disease Control and Prevention has more
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