This was successfully posted to your pofile.
This box will close automatically in a few seconds. Close this window
We don't have an e-mail address on file for you. To use AAFP Connection, you must have an e-mail address in our records. Click Here
Birth Defects Linked to Fluconazole Prompt Change in Pregnancy Category
High Doses of Drug in First Trimester Pose Risk, Says FDA
By News Staff
The FDA said in an Aug. 3 safety announcement that those risks do not appear to be associated with the single 150-mg dose of fluconazole that is used to treat vaginal candidiasis. When used for that indication, the drug retains its category C designation, which means there are no adequate studies in humans, and, although studies of animals have shown an adverse effect on the fetus, potential benefits may warrant use of the drug in pregnant women despite potential risks.
In addition to vaginal candidiasis, fluconazole is used to treat yeast infections of the mouth, throat, esophagus, and other organs, as well as coccidioidal meningitis.
The FDA issued the following information for physicians:
- Published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in utero to high-dose fluconazole during the first trimester.
- The features seen in affected infants include brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease.
- If fluconazole is used during pregnancy, or if a patient becomes pregnant while taking fluconazole, the patient should be informed of the potential risks.
- Adverse events involving fluconazole should be reported to the FDA's MedWatch program.
Share this on AAFP Connection
This was successfully posted to your pofile.
This box will close automatically in a few seconds. Close this window
We don't have an e-mail address on file for you. To use AAFP Connection, you must have an e-mail address in our records. Click Here
Remain Vigiliant for Novel Coronavirus, Says CDC
DTaP Remains in Short Supply This Summer
Though Waning, H7N9 Still Poses Pandemic Potential
AUA Says No to Routine PSA Screening
AAFP Criticizes Appeal of Plan B One-Step Ruling
AAFP to Hospitals: Stop Early Elective Deliveries
AAFP, USPSTF Differ Somewhat on HIV Screening Guidance
Zoledronic Acid Confers Both Pros, Cons
ACP Issues Guidance on PSA Screening
Abbott Recalls FreeStyle InsuLinx Blood Glucose Meter
Discuss Drug Options With Women at Risk for Breast Cancer
Shingles Vaccine Effective, But Uptake Is Low
Evidence Lacking to Make Oral Cancer Screening Recommendation
Two External Guidelines Get Qualified AAFP Endorsement
USPSTF Recommends BRCA Testing for High-risk Women
Primary Care, Public Health Look for Ways to Integrate
Malfunction Prompts Glucose Meter Recall
Evidence Lacking on PAD Screening, Says USPSTF
Azithromycin Poses Arrhythmia Risk, Says FDA
Vets With PTSD Often Prescribed Inappropriate Meds
AIM-HI Offers Grants to Combat Childhood Obesity
USPSTF Says No to Low-dose Vitamin D, Calcium to Prevent Fractures
PCV13, HibMenCY Vaccine Changes Approved by ACIP
AAFP, Other Groups Release More Choosing Wisely Lists
National Office Champions Tobacco Cessation Project Successful
USPSTF Issues Draft Statement on Glaucoma Screening
Study Examines Overuse, Inappropriate Use of Health Services
Apply to Become an AAFP Vaccine Science Fellow
Study Looks to Reduce PSA Screening Risks
AAP Issues New Clinical Guidance on Type 2 Diabetes
CDC: Adult Vaccination Rates Still Too Low
Pertussis Outbreaks Declining, but Immunization Still Key
2013 Immunization Schedules Include Several Changes
FDA Warns of Liver Injury Risk With Samsca Use
FDA Approves First Recombinant Trivalent Influenza Vaccine
AAFP, USPSTF: Screen Women of Childbearing Age for Partner Violence
Breast Cancer Screening in Older Women Costly, Likely Ineffective
CDC Gives Flu Update, Urges Continued Vaccination
Aerobic Exercise Beats Resistance Training for Weight Control