Label Changes for:

Ancobon (flucytosine) 250 mg and 500 mg Capsules

May 2009

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.

 

PRECAUTIONS

Pregnancy: Teratogenic Effects/ Pregnancy Category C

  •  Studies in pregnant rats have shown that fluocytosine injected intraperitoneally crosses the placental barrier.

ADVERSE REACTIONS

Gastrointestinal

  • including hepatic necrosis
  • enterocolitis

Hematologic

  • and fatal cases of bone marrow aplasia
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