Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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. Read about the new physician labeling format.|
|Brand (Generic) Name||
Levaquin (levofloxacin) Tablets
Levaquin (levofloxacin) Injection
Levaquin (levofloxacin in 5% dextrose) Injection
Levaquin (levofloxacin) Oral Solution
“new safety information” with the use of Levaquin, particularly the increased risks of tendonitis and tendon rupture.