Study Claims Fluconazole Raises Risk of Miscarriage and Birth Defects
The U.S. Food and Drug Administration (FDA) is currently reviewing a Danish study that suggests a popular vaginal yeast infection medication increases the risk of miscarriage if used while pregnant. Fluconazole is the only oral medication available for treatment of yeast infections and is the quickest-acting medication for resolving an infection. The FDA has long recommended against, but not banned, the use of fluconazole for pregnant women.
Source and Treatment of Candidiasis
Candida albicans is a type of fungus which occurs in the body naturally in small amounts. Normally found on the skin, mucous membranes, and in the gastrointestinal tract, this organism causes an infection called Candidiasis when overgrowth occurs. When the overgrowth is in the mouth, it is commonly called “thrush.” Genital/Vulvovaginal Candidiasis (VVC) is better known as a yeast infection and affects 75% of women at some point in their lives. A less common, but more deadly, form of candidiasis occurs when Candida enters the bloodstream. This infection, called invasive candidiasis or candidemia, is most often introduced into the body during surgery or during hospital procedures and does not represent a progression of the other kinds of candidiasis.
VVC or yeast infections are caused by an imbalance of some kind in the vagina. This imbalance can be due to hormonal or acidity changes whose root causes include pregnancy, diabetes, use of antibiotics or corticosteroids, or other conditions impacting the flora of the gastrointestinal tract. Symptoms include genital itching, burning, and in women, a thick, white discharge.
The infections are treated with antifungal medications that come in the form of creams, suppositories, and in the case of fluconazole or Diflucan, pills and oral suspension. Fluconazole works by inhibiting a key enzyme in fungus production, thereby making it much more difficult for the organism to grow and overproduce. It is around 90% effective.
Old Risk, New Risk
While current labeling of the drug notes a single, 150 milligram dose of fluconazole during pregnancy is safe, the FDA has previously warned of possible birth defects at higher doses. In 2011, the FDA changed long-term, high dose use of fluconazole from pregnancy Class C to Class D, acknowledging positive evidence of human fetal risk at long-term doses of 400-800 milligrams per day. This dosage is not typically used for yeast infection treatment and is reserved for more serious systemic candidiasis, such as is seen in HIV-positive patients or other individual with compromised immune systems. Possible birth defects in these cases include:
- Abnormalities of the head, face, or skullcap;
- Cleft lip;
- Cleft palate;
- Malformations of the thigh bones or ribs;
- Joint deformities and muscle weakness;
- Congenital heart disease.
The use of fluconazole for yeast infection treatment and given in a single, 150 mg dose remained in pregnancy Class C, meaning animal studies have shown some adverse fetal effects, so risk has not been ruled out. The new Danish study has caused the FDA to undertake a serious review of the data, as it presents new evidence showing higher risk at lower doses typically used for treatment of yeast infections. In fact, the study shows a 50% higher chance of fetal death (miscarriage) or stillbirth for those who used even one or two 150 mg doses of fluconazole. The study also acknowledges birth defect risks at these lower doses.
The FDA expects to conduct a full review of the Danish study and other data and may take action based on their findings. If you took fluconazole during pregnancy and your child was born with birth defects or you experienced a miscarriage, the anti-fungal drug may be to blame. Contact the Indianapolis-based defective drug attorneys at Wagner Reese today for a FREE consultation: (888) 204-8440.