FDA Warning: Yeast Infection Drug May Increase Risk of Miscarriage

April 28, 2016



On Tuesday, April 26th, the FDA announced that oral fluconazole (Diflucan) may contribute to increased risk of miscarriage when taken during pregnancy.  In its announcement, the Agency stated that it is evaluating the results of a Danish study suggesting that there could be a link between miscarriages and the product’s use.  “We are also reviewing additional data and will communicate our final conclusions and recommendations when our review is complete,” said the FDA.

What is fluconazole?

Fluconazole, sold under the brand name Diflucan and also as generics, is used to treat “yeast infections of the vaginal area, mouth, and esophagus.”  In addition, the medication can also be used to treat a fungal infection of the brain and spinal cord called cryptococcal meningitis that most often affects people with weakened immune systems, and used to prevent yeast infections that can spread to the rest of the body in cancer patients who have a weakened immune system.” The product works by killing the fungus or yeast as well as preventing further growth.  Fluconazole is available in powder (for suspension), capsule, and tablet form and can be obtained only with a prescription.

FDA Warning

FDA says that health care professionals should be aware of the Center for Disease Control and Prevention’s (CDC’s) guidelines that advise pregnant women to use only topical antifungal products to treat vulvovaginal yeast infections, “including for longer periods than usual if these infections persist or reoccur.”

FDA also advises patients who are either pregnant or trying to become pregnant to talk to their doctor about alternative treatment options for yeast infections.

“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,” said the Agency in its recent warning about the medication.

General Regulatory Drug Approval

October 5, 2021

Four Benefits of Requesting an FDA Pre-IND Meeting

Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...

Read the Full Article
Agency Alerts General Regulatory

June 13, 2017

FDA Warns OTC Manufacturer After Finding Inaccurate Information in Product Listings

On Thursday, June 1st, the FDA issued a Warning Letter to Prestige Brands Holdings, an over-the-counter (OTC) drug manufacturer. PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s...

Read the Full Article
Agency Alerts General Regulatory

October 12, 2015

FDA Insider Shares Thoughts on Priority Review Vouchers

FDA’s priority review voucher program allows drug makers to receive expedited review of drug products intended to treat rare or neglected diseases (more details in our blog post here). The program...

Read the Full Article