Diflucan Side Effects Linked To Increased Miscarriage Risk: Study
New research suggests that side effects of the yeast infection drug Diflucan may increase the risk of women suffering a miscarriage when taken during pregnancy.
In a study published this week in the Journal of the American Medical Association (JAMA), researchers from Denmark found that women who took Diflucan during the first two trimesters of pregnancy had a 50% increased risk of miscarriage.
The miscarriage risk adds to concerns over the potential side effects of Diflucan, which has been linked to an increased risk of birth defects when used by pregnant women as well.
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Diflucan (fluconazole) is a prescription drug introduced by Pfizer used to treat yeast infections of the vagina, mouth, esophagus and other organs. It is also used to treat some kinds of meningitis and used as a yeast infection preventative in patients being treated with chemotherapy or radiation therapy before receiving a bone marrow transplant.
In recent years, case reports have suggested that Diflucan side effects cause a pattern of birth defects when high-doses of the medication are used to treat severe fungal infections during pregnancy.
This latest study looked at data on 1,405,663 pregnancies in Denmark from 1997 to 2013, with outcomes for those women using Diflucan during pregnancy compared to those who did not.
Researchers found that, of 3,315 women who took Diflucan before the 22nd week of gestation, 147 experienced a spontaneous abortion. That compares to 563 miscarriages among 13,246 women who did not use the drug who were matched based on a number of similar factors, such as gestational age, maternal age and other similar traits. Researchers calculated the increased risk to be about 48%.
“In this nationwide cohort study in Denmark, use of oral fluconazole in pregnancy was associated with a statistically significant increased risk of spontaneous abortion compared with risk among unexposed women and women with topical azole exposure in pregnancy,” the researchers determined. “Until more data on the association are available, cautious prescribing of fluconazole in pregnancy may be advisable.”
In August 2011, the FDA issued a drug safety communication about the potential Diflucan pregnancy risks, warning that the agency was changing high doses of Diflucan from a Category C to a Category D pregnancy drug, meaning that there was positive human evidence of a risk of birth defects.
The agency did not change the category for single, low-dose uses, but high doses were associated with a number of rare and distinct birth defects and congenital anomalies.
Case studies have linked Diflucan to birth defect risks when taken in the first trimester, at time when many woman do not even know they are pregnant.
According to the FDA, birth defects seen in infants exposed to long-term, high-doses of Diflucan during the first trimester included abnormal head, skull and face defects, cleft palate, cleft lip, bowing of the thigh bones, thin ribs, long bones, muscle weakness, joint deformities and congenital heart disease at birth.
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