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FDA Warning: Oral Diflucan May Increase Miscarriage Risk

FDA Warning: Oral Diflucan May Increase Miscarriage Risk

April 26, 2016 — The FDA is investigating a study linking the oral yeast infection drug Diflucan (fluconazole) with a 50% increased risk of miscarriage.

In January 2016, JAMA Internal Medicine published a study by researchers in Denmark who tracked outcomes for women who used Diflucan during weeks 7-22 of pregnancy.

They found a 48% increased risk of spontaneous abortion compared to women who did not use Diflucan or intravaginal formulations of topical azole anti-fungals. Of the 3,315 women exposed to oral Diflucan, 147 had a miscarriage.

The conclusions of the study were based on data from a national registry of 1.4 million pregnancies in Denmark between 1997 and 2013. The researchers warned:

“Until more data on the association are available, cautious prescribing of fluconazole in pregnancy may be advisable. Although the risk of stillbirth was not significantly increased, this outcome should be investigated further.

The label currently states that single 150-mg doses of Diflucan are not associated with birth defects or miscarriage. Most of the women in the Danish study took either one or two 150-mg dose.

In August 2011, the FDA warned that high-doses of Diflucan (400-800 mg/day) are associated with a rare and distinct set of birth defects, including:

  • Short, broad head
  • Abnormal looking face
  • Abnormal skull development
  • Cleft palate
  • Thin ribs, long bones, and bowed femur
  • Muscle weakness and joint deformity
  • Congenital heart disease

Diflucan (fluconazole) is primarily used to treat vaginal yeast infections, which are very common during pregnancy. It is also approved to treat yeast infections in the mouth and esophagus and cryptococcal meningitis, a fungal infection in the brain and spinal cord.

Do I have a Diflucan Lawsuit?

The Schmidt Firm, PLLC is currently accepting Diflucan induced injury cases in all 50 states. If you had a miscarriage or your child was born with a birth defect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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