Label Changes for:
Mepron (atovaquone) Suspension
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.|
- 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...
- 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