August 3, 2011 — The US Food and Drug Administration (FDA) warned today that chronic use of fluconazole (Diflucan, Pfizer)
in high doses (400 - 800 mg/day) during the first trimester of
pregnancy may be associated with certain birth defects in infants.
The risk does not appear to be associated with a single, low dose of fluconazole (150 mg) used to treat vaginal candidiasis (yeast infection), the agency emphasizes.
According to the agency, "a few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in utero to high-dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester."
"The features seen in these infants include brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease. These effects are similar to those seen in animal studies," the agency notes.
Four of the case reports involved maternal use of chronic high-dose intravenous fluconazole for coccidioidal meningitis, and 1 report involved an HIV-positive mother who received chronic high-dose oral fluconazole for vaginal candidiasis.
Cases associated with high-dose fluconazole use all shared some characteristics with the autosomal recessive genetic disorder known as Antley-Bixler syndrome, the FDA notes. This combination of congenital anomalies occurs rarely in the general population and is similar to anomalies seen in animals following in utero fluconazole exposure.
Category Change
On the basis of available information, the FDA has changed the pregnancy category for fluconazole indications (other than vaginal candidiasis) from category C to category D.
"Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks," the FDA explains.
The pregnancy category for a single, low dose of fluconazole has not changed and remains category C.
The FDA recommends that healthcare professionals counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug. "If a patient uses fluconazole during pregnancy, the patient should be informed of the potential risk to the fetus," the agency says.
More information on the alert is available on the FDA Web site.
Adverse events related to this product can also be communicated to MedWatch, the FDA's adverse event and reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
The risk does not appear to be associated with a single, low dose of fluconazole (150 mg) used to treat vaginal candidiasis (yeast infection), the agency emphasizes.
According to the agency, "a few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in utero to high-dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester."
"The features seen in these infants include brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease. These effects are similar to those seen in animal studies," the agency notes.
Four of the case reports involved maternal use of chronic high-dose intravenous fluconazole for coccidioidal meningitis, and 1 report involved an HIV-positive mother who received chronic high-dose oral fluconazole for vaginal candidiasis.
Cases associated with high-dose fluconazole use all shared some characteristics with the autosomal recessive genetic disorder known as Antley-Bixler syndrome, the FDA notes. This combination of congenital anomalies occurs rarely in the general population and is similar to anomalies seen in animals following in utero fluconazole exposure.
Category Change
On the basis of available information, the FDA has changed the pregnancy category for fluconazole indications (other than vaginal candidiasis) from category C to category D.
"Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks," the FDA explains.
The pregnancy category for a single, low dose of fluconazole has not changed and remains category C.
The FDA recommends that healthcare professionals counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug. "If a patient uses fluconazole during pregnancy, the patient should be informed of the potential risk to the fetus," the agency says.
More information on the alert is available on the FDA Web site.
Adverse events related to this product can also be communicated to MedWatch, the FDA's adverse event and reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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