Recent studies have linked Trican (fluconazole) to an increased risk of birth defects when high doses are taken during the first trimester of pregnancy. Although case reports have linked Trican and birth defects since the 1990s, warnings were only added to the label in 2010.
Need a Texas Trican Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one had a baby with a birth defect after taking Trican during pregnancy, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
What is Trican (fluconazole)?
Trican (fluconazole) is an anti-fungal medication sold by Pfizer. Trican is primarily used to treat Candida (yeast) infections of the vagina, mouth, and esophagus. It is also used to treat fungal meningitis infections and opportunistic fungal infections in people with weakened immune systems.
Evidence Linking Trican and Birth Defects
Pregnant women are more susceptible to yeast infections, which is why Trican is often prescribed during pregnancy. This has raised concern about a potential risk of birth defects. The first case reports linking Trican and birth defects include:
- 1992 — A 22 year-old woman who used 400-mg/day fluconazole had a baby with birth defects of the face, skull, bones, cleft palate, bowed femur, and more.
- 1996 — Case reports link two more cases of birth defects to high-dose fluconazole, including severe cranial defects in an infant exposed to 800-mg/day.
- 1997 — Infant exposed to 1200-mg/day fluconazole in a woman with meningitis was born with severe birth defects of the skull, face, joints, and more.
- 2005 — Infant exposed to 400-mg/day fluconazole in a mother with HIV had a baby with long bones and birth defects of the skull.
Additional case reports are described in Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, published in March 2012 by Gerald G. Briggs, Roger K. Freeman, and Sumner J. Yaffe.
Trican Birth Defects
Birth defects seen in infants exposed to high-dose fluconazole resemble Antley-Bixler Syndrome. These symptoms include:
- Short, broad head (brachycephaly)
- Abnormal facial features
- Abnormal skull cap
- Cleft lip
- Cleft palate
- Bowed thigh bones
- Thin ribs
- Long bones
- Muscle weakness
- Joint stiffness or immobility (arthrogryposis)
- Congenital heart disease
- Heart defects
- Tetralogy of Fallot
Single-Dose Trican Linked to Heart Defect (Tetralogy of Fallot)
August 29, 2013 — The New England Journal of Medicine has published a study investigating the risk of birth defects from single doses of 150-mg fluconazole. They found that birth defects occurred in 2.86% of fluconazole-exposed babies, compared to 2.6% of non-exposed babies. Researchers found a 3.16-fold increased risk of Tetralogy of Fallot, a severe heart defect, although the number of cases was small.
FDA Safety Warnings for Trican
In August 2010, the U.S. Food and Drug Administration (FDA) published a Drug Safety Communication to warn that pregnant women who take at least 400-mg/day of Trican during the first three months of pregnancy (first trimester) could have a baby with a distinct set of birth defects.
The Pregnancy Category has been changed from a C to a D, meaning that there is positive evidence linking Trican and birth defects, but the benefits may outweigh the risk for pregnant women with severe fungal infections.
Need a Trican Lawyer in Texas?
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The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact our Texas Trican lawyers for a free lawsuit review.