The Food and Drug Administration recently added a strong warning to the yeast infection drug Diflucan for women who are pregnant, saying that even small doses have been associated with a higher risk of miscarriage.
Diflucan, taken orally, was approved by the FDA in 1990 and is sold by Pfizer. It is prescribed for a variety of fungal infections in the lungs, bladder, esophagus, mouth and blood, and is also indicated to fight infections in those with cancer or weakened immune systems. But it is used most often for vaginal yeast infections.
The agency had previously warned that the drug may cause a higher incidence of certain birth defects when taken during the first trimester, however, this is the first warning to address miscarriages.
Danish Study Shows Diflucan Miscarriage Link
The April 26 FDA warning came after a study out of Denmark found that women who took Diflucan from between the 7th and 22nd week of pregnancy for yeast infections had “significantly” higher chances of miscarriage.
And, in most cases, patients in the study had only used the recommended dose of 150 mg once or twice.
Now, the FDA will launch its own investigation to further examine the Danish study, as well as other available clinical data.
2011 FDA Warning About Diflucan Birth Defects
This isn’t the first warning to surface about the use of Diflucan during pregnancy. In 2011, the FDA warned that extended use of the 400 to 800 mg dosages of the drug during the first trimester could be linked to birth defects of the skull and cleft palate, among others.
The drug currently carries a label warning for such birth defect risks, but does not mention anything about miscarriages.
FDA Recommends Caution in Prescribing Diflucan
At this time, the FDA recommends that doctors use caution in prescribing Diflucan to women who are pregnant, until such time as the agency can complete its review. Those who are currently pregnant or are trying to become pregnant are advised to speak with their doctor about other treatment options.
It is important to note that the Centers for Disease Control and Prevention advises that women who are pregnant only be prescribed topical antifungal products for vulvovaginal yeast infections, not oral ones.
Lawyers are currently investigating whether Pfizer had prior information about the risk of miscarriages in pregnant women who took the drug but didn’t warn patients. If so, they may be liable for damages to those families affected.
For more information on the current warnings and side effects related to Diflucan, or to speak with a lawyer, contact DrugNews today.
FDA Drug Safety Communication: FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy. (April 26, 2016). Retrieved from www.fda.gov
Lowes, R. Low-Dose Fluconazole in Pregnancy Worries FDA. MedScape. (April 26, 2016). Retrieved from www.medscape.com
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.