Safety Alerts & Recalls
What does this mean?
If you are a woman who is pregnant or actively trying to get pregnant, this is a good reminder to tell all of your healthcare providers if you are pregnant or share your family planning goals with them. They will need to take this into account when they prescribe medicines, diagnostic tests, or medical procedures for you.
If you develop yeast infection while pregnant or actively trying to get pregnant, you should talk to your healthcare provider about alternative treatment options for yeast infections. If you have questions or concerns about this safety alert or any of your medicines, please follow up with your healthcare provider.
Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:
--- Telephone: 1-800-332-1088
--- Fax: 1-800-332-0178
--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
--- Website: http://www.fda.gov/Safety/MedWatch/default.htm
FDA Is Reviewing a Study Linking Fluconazole Use and Risk of Miscarriage
The U.S. Food and Drug Administration (FDA) is evaluating the results of a Danish study that linked a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections.
The current FDA prescribing information states that data available from studies in people do not suggest an increased risk of problems during pregnancy or abnormalities in developing babies when women are exposed to a single 150 mg dose of oral fluconazole to treat vaginal yeast infections. However, high doses of oral fluconazole (400-800 mg/day) taken by pregnant women for much longer than a single dose have resulted in reports of abnormalities at birth. In the Danish study, most of the oral fluconazole use appeared to be one or two doses of 150 mg – similar to the doses women take for yeast infection.
The FDA is reviewing the Danish study results plus additional data and will report final conclusions and recommendations when the review is complete. Until the FDA's review is complete and more is understood about this study and other available data, the FDA advises doctors to use caution when prescribing oral fluconazole.
Oral fluconazole is used to treat yeast infections of the vaginal area, mouth, and esophagus. It is also used to treat a fungal infection of the brain and spinal cord called cryptococcal meningitis. Fluconazole is available under the brand name Diflucan and also as generics.
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