Label Changes for:

Mepron (atovaquone) Suspension

May 2008

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 2008

 

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.


Summary View

Sections Modified

PRECAUTIONS

  • General
    • Rare cases of hepatitis, elevated liver function tests and one case of fatal liver failure have been reported in patients treated with atovaquone. A causal relationship between atovaquone use and these events could not be established because of numerous confounding medical conditions and concomitant drug therapies...

ADVERSE REACTIONS

  • Postmarketing Experience
    • Blood and Lymphatic System Disorders
    • Immune System Disorders: Hypersensitivity reactions including angioedema, bronchospasm, throat tightness, and urticaria.
    • Eye Disorders
    • Gastrointestinal Disorders: Pancreatitis
    • Hepatobiliary Disorders: Rare cases of hepatitis and one case of fatal liver failure have been reported with atovaquone usage.
    • Skin and Subcutaneous Tissue Disorders: ...Stevens-Johnson syndrome, and skin desquamation have been reported in patients receiving multiple drug therapy including atovaquone.
    • Renal and Urinary Disorders
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