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Diflucan® and Muscle Weakness

Newborn weakness of the muscles and joints, when it occurs with other anomalies, might signify the child has Antley-Bixler syndrome, a rare genetic disorder. Other characteristics that distinguish this syndrome include:

  • Short, broad head
  • Abnormal looking face, including protruding eyes and cleft lip or palate
  • Abnormal development of the skullcap
  • Bowing of the thigh bones
  • Congenital heart disease
  • Thin ribs, thigh bones, and fingers

This cluster of symptoms has been linked by some published reports in the medical literature and by the U.S. Food and Drug Administration to the mother's use of high doses of Diflucan® (fluconazole) during the first trimester of her pregnancy. As a result of this association between the syndrome and high dose usage of Diflucan®, the FDA has changed the label on the medication to a category D pregnancy drug from a category C drug.

This category D applies only to Diflucan® when used in high doses (400 mg to 800 mg) over an extended period of time. A single low dose (150 mg) is not considered to harm the fetus and Diflucan® remains as a pregnancy C category medication in this instance.

Category C drugs have been shown to cause fetal birth defects in animals whose mothers were exposed to a drug, but there are no "adequate and well-controlled studies in humans." The potential benefits of the drug might outweigh the possible risks when taken by pregnant women.

Category D drugs have positive evidence of human fetal risk. This information is based on studies or experience with these drugs after they were on the market. The risks of using these drugs in pregnant women clearly outweigh any potential benefits.

Diflucan® and FDA Alert

Diflucan® is an antifungal drug used to treat yeast infections of the vagina, mouth, esophagus and other organs. It is used to treat meningitis caused by a certain fungus. It also is prescribed to prevent yeast infections in patients undergoing chemotherapy or radiation therapy before a bone marrow transplant.

The FDA published a safety communication on the subject in August 2011. It warned patients that:

  • Long-term use of Diflucan® in high doses during the first three months of pregnancy puts the fetus at risk of developing Antley-Bixler syndrome.
  • The pregnancy category for Diflucan® is now a category D for indications other than a vaginal yeast infection.
  • A single dose (150 mg) of Diflucan® to treat a vaginal yeast infection does not appear to be associated with birth defects.

Contact a Diflucan® Birth Defects Lawyer

If you took high doses of Diflucan® during your pregnancy and your baby is born with a birth defect, you may qualify to seek compensation. To find out if you qualify, please contact our birth defect lawyers today. We provide free case reviews for parents who believe they may have a claim. Call today to find out how we can help you and your baby.

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