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Yeast Infection Drug May Cause Miscarriage

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A report from the US Food and Drug Administration on Tuesday cautioned doctors in prescribing pregnant women with fluconazole, an oral drug to treat yeast infections, as new research has linked the drug to possible miscarriages.

Yeast infections affect some 10% of pregnant women, a period that makes them more vulnerable. Symptoms include painful sex, abnormal vaginal discharge and itchiness in the genital area.

The FDA issued a previous warning that continuous use of fluconazole in high doses, brand name Diflucan, has shown evidence linking it to “a rare and distinct set of birth defects” in infants whose mothers took the drug in their first trimester. The doses were from 400-800mg a day, states the case reports.

A recent Danish study conducted at the State Serum Institute in Copenhagen is showing more negative effects from fluconazole use. The researchers did a review of medical records covering 1.4 million pregnancies in Denmark in 17 years.

Data showed that among the estimated 3,300 women who took the oral drug while 7 to 22 weeks pregnant, around 150 of them miscarried, compared with some 560 of 13,000 women matched for maternal and gestational age.

Pregnant women who used fluconazole in their first 22 weeks had a higher risk for miscarriage compared to those who did not use the drug. On the other hand, there was no evidence found linking fluconazole use and stillbirths.

Lyndsay Meyer, a representative for the FDA, stated that it is unclear whether the agency would announce any further recommendations. However, “until F.D.A.’s review is complete and more is understood about this study and other available data, we advise cautious prescribing of oral fluconazole in pregnancy,” she said in an email to The New York Times.

The Centers for Disease Control and Prevention have given the recommendation to use topical products to treat yeast infection in pregnancy. The same study also did a comparison of women who used topical azole yeast infection treatments and women who took the drug orally. The researchers found that the latter had a higher chance of miscarriage.

Rachel Hooper of Pfizer, the company that makes fluconazole, maintains that the drug has shown an effectivity, and a “well-established benefit risk-profile” in over 25 years of patient use.

The research, headed by Ditte Molgaard-Nielsen, was published in The Journal of the American Medical Association.

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