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.