Label Changes for:
Ancobon (flucytosine) 250 mg and 500 mg Capsules
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2009
|The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.
Pregnancy: Teratogenic Effects/ Pregnancy Category C
- Studies in pregnant rats have shown that fluocytosine injected intraperitoneally crosses the placental barrier.
- including hepatic necrosis
- and fatal cases of bone marrow aplasia