Malarone (atovaquone and proguanil hydrochloride) Tablets December 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 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. Read about the new physician labeling format.

Summary View

 

Sections Modified

ADVERSE REACTIONS

• Postmarketing Adverse Reactions
  • Immune System Disorders
    • vasculitis (added)
  • Gastrointestinal Disorders (new subsection)
    • stomatitis
  • Hepatobiliary Disorders
    • cholestasis (added)