The U.S. Food and Drug Administration (FDA) is currently reviewing a Danish study that indicates popular yeast infection drug Diflucan can cause miscarriages. While reviewing the Danish study and other data, the FDA is urging healthcare providers to be cautious when prescribing Diflucan, or its generic alternative fluconazole, during pregnancy. Healthcare providers and patients are also urged to report any adverse events that may occur while taking Diflucan, or shortly thereafter.
What is Diflucan?
Diflucan and generic fluconazole are manufactured by Pfizer for the treatment of yeast infections. Diflucan is commonly prescribed to patients suffering from yeast infections of the mouth, esophagus, and vaginal area. As an azole antifungal, fluconazole interferes with the formation of fungal cell membranes, thus killing the sensitive fungi. Fluconazole is known to successfully treat yeast infections, such as:
- Oropharyngeal candidiasis (also known as thrush)
- Vaginal candidiasis
- Esophageal candidiasis
- Miscellaneous candida infections including peritonitis, urinary tract infections, fungal meningitis, and gastrointestinal inflammation
Diflucan and Pregnancy
Yeast infections in the vaginal area (vaginal candidiasis) are particularly common among pregnant women due to changes in hormones. Generally, healthcare providers are urged to treat pregnant women with topical medications, such as over-the-counter creams or suppositories like Monistat (miconazole nitrate), Gyne-Lotrimin (clotrimazole), or Vagistat-1 (ticonazole). In severe or persistent yeast infection cases, however, oral Diflucan may be prescribed during pregnancy.
Current labeling for Diflucan and fluconazole products indicates that human studies do not suggest increased risks during pregnancy when women are exposed to single 150mg oral dosage. However, the FDA released a warning statement in 2011 warning that high doses, such as 400-800mg per day, may result in birth abnormalities including brachycephaly (flattened rear skull) and cleft palate. Results from the Danish study, however, suggest that even small doses of fluconazole (the standard dose studied was 150mg 1-2 times per day) may increase the risk of miscarriage.
Diflucan has been classified as a category D for use during pregnancy, which means that the FDA has found scientific evidence to support that there are risks associated with its use, including birth defects. In general, a category D suggests that the benefits of appropriate use may outweigh the risks. Category D is the second most severe FDA label.
The Danish Study
The report released by Danish researchers in January indicates that Diflucan can cause miscarriages. The study examined over one million pregnancies from 1997-2013 where fluconazole was ingested, and then compared the findings with similar pregnancies where the mother was not exposed to fluconazole. The results of the study suggest a clear correlation between exposure to fluconazole and complications during pregnancy, including miscarriage. Some of the most significant results indicated the following:
- Simply put, the study results indicate that women exposed to oral fluconazole during the first six months of pregnancy may be as much as 50 percent more likely to suffer a miscarriage than women without exposure.
- Of the 3,315 women exposed to fluconazole at 7-22 weeks gestation, 147 suffered spontaneous abortion, compared with 563 out of 13,246 unexposed women.
- Of the 5,382 women exposed to fluconazole at 7 weeks gestation to birth, 21 suffered a stillbirth, compared to 77 out of the 21,506 unexposed women.
Medication and Birth Defects/Miscarriage
There are numerous medications that can cause adverse events during pregnancy. In another post, we have discussed the link between certain medications and birth defects or complications of pregnancy, including:
- SSRI Medications: Used to treat anxiety and depression, dangerous medications include Zoloft, Paxil, Lexapro, Symbyax, and Prozac.
- Accutane: Used to treat acne, Accutane has been linked to severe birth defects and infant death.
- NSAIDS: Anti-inflammatory drugs like Motrin, Aleve, Bayer, and Excedrin have been linked to birth defects and abnormalities.
In light of the recent research and continued review, we find it necessary to add fluconazole, a.k.a. Diflucan, to the list of potentially dangerous medications.
Information for Patients
While the FDA has previously warned about oral fluconazole and potential risks during pregnancy, the recent information obtained in the Danish study suggests that there is still much to learn about how dangerous this drug can be. Patients who are pregnant, or are planning to become pregnant, should monitor progress of the FDA’s review and address treatment of yeast infections accordingly.
The FDA has guidelines for many medications and pregnancy, but the truth is, there is relatively little information available about how most medications interact with pregnancy. Healthcare providers are responsible for ensuring the medications they prescribe are safe for you, both in the short- and long-term, based on what is known about the medication and risks.
You can find additional information about medications and potential risks, as well as documented adverse event reports via the following:
- Organization of Teratology Information Specialists (OTIS): Works with pregnant women who have contacted them after taking medications to determine the safety and risks during pregnancy, or while breastfeeding.
- Adverse Event Reports: Organized through the FDA’s MedWatch Program, these reports are submitted by healthcare providers, researchers, and patients to record actual events.
- National Birth Defects Prevention Study (NBDPS): Organized by the Centers for Disease Control and Prevention (CDC), the NBDPS seeks to identify risk factors associated with taking certain medications during pregnancy.
- Pregnancy Registries: Sometimes drug manufacturers will conduct studies based on registries of pregnant women who have taken certain medications. After giving birth, the health of the child is compared to that of other children not exposed to the medication.
Your Legal Rights
As a patient, you have the right to receive quality care, which includes being prescribed only medications that are safe and applicable to your health and treatment of certain conditions. This is especially true if you are pregnant or planning to become pregnant soon. Always talk to your healthcare provider before choosing a medication or switching medications, even if they are over-the-counter.
If you have been prescribed Diflucan while pregnant, and have experienced a miscarriage or other pregnancy or birth-related complications, contact the birth injury attorneys at Brown Wharton & Brothers for a free case review. Defending your rights and seeking justice against drug manufacturers like Pfizer, as well as healthcare providers, can be daunting. It is important that you know that you are not alone.