Levaquin (Levofloxacin) is a fluroquinolone antibiotic used to treat bacterial infections, and is available only by prescription. On July 8, 2008, the FDA ordered the manufacturer to add a Black Box warning to Levaquin. A Black Box warning is the strongest warning available for prescription drugs. The FDA also required that a guidebook be provided to patients warning about the possible side effects.
People that have been prescribed Levaquin have filed lawsuits claiming that it causes ruptured tendons and that the defendants’ warnings about this side effect were inadequate.
Defendants Johnson & Johnson, Ortho-McNeil Pharmaceutical, Inc., and Johnson & Johnson Pharmaceutical Research & Development are denying that Levaquin is defective or unreasonably dangerous. Defendants are also denying that they failed to provide adequate warnings.