FDA Investigating Fluconazole Risk Of Miscarriage When Prescribed To Pregnant Women
The U.S. Food and Drug Administration (FDA) has warned health care professionals to use caution when prescribing fluconazole to treat yeast infections in pregnant women. The antifungal medication Fluconazole or Diflucan may pose an increased risk of miscarriage based on studies the federal regulatory agency has reviewed.
The FDA issued a safety announcement in late April regarding fluconazole, which is marketed under the brand name Diflucan and manufactured by Pfizer Inc. However, generic fluconazole is available through other drug makers. Fluconazole is used to treat yeast infections of the vaginal area, mouth, and esophagus, cryptococcal meningitis (a fungal infection of the brain and spinal cord), and used to prevent yeast infections that can spread to the rest of the body in cancer patients who have a weakened immune system, according to the FDA. The federal agency recommends doctors follow the Centers for Disease Control and Prevention’s guidelines of using topic anitfungals to treat pregnant women with yeast infections.
[fda.gov/Drugs/DrugSafety/ucm497482.htm, FDA, April 26, 2016]
The current FDA drug label states that studies do not suggest an increased risk of problems for developing babies when expectant mothers are exposed to a single 150 mg dose of oral fluconazole to treat vaginal yeast infections. However, birth defects in babies have been reported when pregnant women take higher doses of oral fluconazole (400-800 mg/day) for much longer than a single dose.
The FDA now says it is evaluating data from a Danish study that has found a link between using fluconazole during pregnancy and the risk of spontaneous abortion. The Danish study examined a cohort of 1,405,663 pregnancies from 1997-2013 and compared oral fluconazole-exposed pregnancies with up to 4 unexposed pregnancies matched on propensity score, maternal age, calendar year, and gestational age. Researchers discovered a 48 percent increased risk of spontaneous abortion associated with fluconazole exposure. No significant association was found between fluconazole exposure and stillbirth. Most of the oral fluconazole use appeared to be 1 or 2 doses of 150mg, according to the study published in January in The Journal of the American Medical Association.
[jama.jamanetwork.com/article.aspx?articleid=2480487, JAMA, January 5, 2016]
The FDA has noted its concerns in the past about the antifungal drug. In August 2011, the federal agency issued a safety announcement warning that chronic, high doses (400-800 mg/day) of Diflucan could cause a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy. The birth defects include a short, broad head, abnormal-looking face, cleft palate, congenital heart disease, muscle weakness and joint deformities. Based on the birth defect reports, the FDA changed the pregnancy category for fluconazole from category C to category D, which means there is positive evidence of human fetal risk based on human data.
[fda.gov/Drugs/DrugSafety/ucm266030.htm#data, FDA, August 3, 2011]
The Diflucan attorneys at Southern Med Law are evaluating Diflucan birth defect complaints involving families who believe their children were injured due to the mother being prescribed Diflucan or generic fluconazole during pregnancy. To learn more about the litigation involving Diflucan and other drugs that cause birth defects, please contact the Firm as soon as possible. You can arrange for a free, no obligation Diflucan lawsuit review by calling Southern Med Law today, at 205-547-5525.
About Southern Med Law and Filing A Diflucan Birth Defect Lawsuit:
Southern Med Law is an experienced law firm providing legal representation individuals across the country who have been victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
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