July 8, 2008—The FDA announced it would require the manufacturer of Levaquin to include a black box warning to alert patients to the risk of tendon ruptures. A black box warning is the strongest warning available to the FDA to inform patients of a drug's risks.
Levaquin is an antibiotic belonging to a class of drugs known as fluoroquinolones. The recall was prompted by data indicating that Levaquin and other fluoroquinolones increase the risk of tendon rupture by three to four times.
Between November 1997 and December 2007, the FDA received more than 400 reports of tendon rupture following use of fluoroquinolones, including Levaquin. The actual number of people who suffered tendon rupture likely is substantially higher, as only a small fraction of adverse events are reported to the FDA.
Public Citizen, a consumer group, first requested that the FDA require a black box warning in August 2006. The group filed a lawsuit against the FDA in 2008 asking that the Court require the FDA to place a black box warning on Levaquin.
Levaquin is manufactured and marketed by Ortho-McNeil-Janssen Pharmaceuticals, a division of Johnson & Johnson.