Study Title:

Levaquin Upgraded to Black Box Warning

Study Abstract

Washington, DC: On July 8, 2008 the FDA announced that Levaquin will get a black box warning on all fluoroquinolone antibiotics because of an increased risk for tendonitis and tendon rupture. The consumer group Public Citizen first petitioned the agency and then sued to get the warning issued.

Levaquin (also known as levofloxacin) is a synthetic antibiotic manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson, and is prescribed to fight infections, including bronchitis, pneumonia, Chlamydia, gonorrhea, skin infections, urinary tract infections, etc. The black box warning given to Levaquin and other drugs in the fluoroquinolones group is intended to ensure physicians and patients understand the increased risks involved and the potential for adverse events, particularly tendon ruptures.

Study Information

Judy Mundy
Levaquin Upgraded to Black Box Warning
2008 July

Full Study