FDA Reviews Diflucan after Study Links Usage to Fetal Death

The Food and Drug Administration has changed the pregnancy category for Diflucan (fluconazole) after a Danish study linked use of the drug during pregnancy to fetal risk. The study, which examined more than 1.4 million pregnancies over 16 years, found that low oral doses in the first trimester could cause birth defects, while high oral doses can result in spontaneous abortion.

Why Diflucan is prescribed to pregnant women

Business Insider reported, “Yeast infections occur in an estimated 10 percent of pregnancies. That’s largely because hormone changes during pregnancy disrupts the pH balance of the vagina, according to Mayo Clinic. Topical azole antifungal creams are typically the first line of treatment for pregnant women with yeast infections, but oral fluconazole is also often used, even though there is little information about its safety, the study said.”

The FDA has issued a Safety Announcement designed to inform both the general public and healthcare professionals in particular about the dangers of prescribing the oral antifungal during pregnancy. However, the agency has decided that a single low dose of the medication poses an insignificant risk. While the statistics uphold this decision, pregnant women who are prescribed a single low dose in the first trimester should be aware that the drug could cause birth defects or fetal death.

Safety Announcement carries unintentional risk

From the FDA, “Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single dose of fluconazole 150 mg to treat vaginal candidiasis has not changed and remains category C [emphasis ours]. Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks.”

While the health of the mother is a significant consideration during pregnancy, administering a low dose of a medication known to cause birth defects and spontaneous abortion seems like an unnecessary risk, especially considering that low dose Diflucan is for minor fungal infections that can usually be treated with a safe topical antifungal. Based on the FDA’s communication, a doctor may be inclined to prescribe a single dose without informing a pregnant patient about the category change for higher doses. This sort of partial advisory creates a moral gray area concerning informed consent, one that could have devastating consequences for a family.

When it comes to medical care, you are your best advocate and knowledge is power. Your healthcare provider has a responsibility to make informed decisions about your treatment, but the FDA is constantly updating and revising information about drugs of all kinds. If you are pregnant and have been prescribed Diflucan, your unborn child may be at risk and you may be a victim of medical malpractice. The experienced South Carolina defective drug attorneys at McGowan, Hood, Felder & Phillips LLC can evaluate your case and help get you the compensation you deserve. Call 803-327-7800 or contact us today for a free consultation.