The U.S. Food and Drug Administration is currently probing whether a drug used for treating yeast infection poses risks when taken during pregnancy.
The agency announced Tuesday that it is reviewing the results of Danish study, which concluded a potential miscarriage risk from the use of oral fluconazole (brand name Diflucan) for yeast infection therapy.
“Until FDA's review is complete and more is understood about this study and other available data, FDA advises cautious prescribing of oral fluconazole in pregnancy," its official statement said.
Published Jan. 5 in the Journal of the American Medical Association, the research found that pregnant subjects who took the oral medication emerged 48 percent more likely to suffer a miscarriage than those who did not take the drug.
Oral fluconazole targets yeast infection in the vagina, mouth, and esophagus, as well as a fungal infection in the brain and spinal cord known as cryptococcal meningitis. In cancer patients who already have weakened immunity, the drug also helps prevent spread of yeast infections to the rest of the body.
Pregnant women are deemed especially at risk for vaginal yeast infection, which the fungus Candida causes. Hormonal changes during this stage, particularly increased estrogen levels, disrupt the normal vaginal pH and lead to yeast overgrowth.
The Danish study added that around 10 percent of pregnant women in the U.S. harbor a yeast infection any time during their term.
While the Centers for Disease Control and Prevention recommends using only topical antifungals such as vaginal suppositories, healthcare providers sometimes prescribe oral fluconazole in a reemergence or severe case of the infection.
According to the current FDA drug label, available data “do not suggest” a greater miscarriage risk when pregnant women are exposed to a single 150-milligram (mg) dose of the medication. High doses of 400 to 800 mg per day taken much longer than a single dose, however, have been seen to lead to documented birth abnormalities.
The Danish study mostly used one or two 150 mg doses.
In its statement, FDA urged doctors to stick to prescription guidelines in treating pregnant women with vaginal yeast infection, which is using only topical methods. Pregnant women or those actively trying to conceive are also encouraged to discuss alternative treatments with their doctors.
