FDA Issues Safety Alert for Fluconazole
April 26, 2016 – The U.S. Food and Drug Administration (FDA) issued a Safety Alert for the use of oral fluconazole by pregnant women. Fluconazole is an antifungal drug indicated to treat vaginal yeast infections with a low dose once daily 150mg tablet. It is also indicated to be used in higher doses and for longer periods, to prevent and treat some types of meningitis, pneumonia and other systemic infections that are caused by several different fungal organisms. A recent study found a possible increase in the risk of miscarriage when only one or two 150mg doses were used. The FDA is evaluating the study and other relevant information, and in the meantime, it advises that topical rather than oral antifungal products be used to treat vaginal yeast infections during pregnancy. Labeling for oral fluconazole, available as generics and the brand name, Diflucan®, manufactured by Pfizer, already have a warning that it should not be used long-term or in high doses for pregnant women because it can cause birth defects such as weakened bones, cleft palate and heart disease. The low, single-tablet dose is thought less likely to cause problems with fetal development.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.