Levaquin, Janssen Pharmaceutical’s brand name for the antibiotic levofloxacin, is an antibacterial drug approved for use in the treatment of a variety of upper respiratory infections, urinary tract infections, prostatitis, and other bacterial infections. It was first introduced into the U.S. market in 1997 and is in a class of antibiotics known as fluoroquinolones. Although considered highly effective at killing certain bacteria, fluoroquinolones have long been associated with serious side effects. Indeed, many fluoroquinolones have been removed from the market due to intolerable adverse events.
According to the U.S. consumer watchdog organization, Public Citizen, by 1996, there were over 130 reports of tendon injury from around the world over a ten-year period and 52 reports of tendon injury in the United States associated with fluoroquinolone use. By 1997, U.S. manufacturers of fluoroquinolones had modified their label. However, the language was buried in a long list of potential (and many less serious) adverse reactions; and this important safety alert was not highlighted in any way, such as with bold lettering, or even a heading titled “tendon injury.” Moreover, no mention was made of the fact that age and corticosteroid use tripled the risk of tendon injury. No letter to physicians was disseminated, and Janssen Pharmaceutical did not highlight this unusual side effect when promoting Levaquin to doctors.
By 2002, the adverse event data in all those countries consistently and unequivocally revealed that the risk of tendon injury was nearly triple for people over 60 as compared to people under 60. All data pointed to the fact that Levaquin was more tendon toxic than all other fluoroquinolones. On May 18, 2005, the Illinois Attorney General submitted a petition to the FDA requesting a black box warning on fluoroquinolones. The Attorney General suggested that the black box was necessary to highlight the seriousness of tendon injuries and that the risk is increased in the elderly and in patients on corticosteroids.
At the request of the FDA, in April 2007 and again in July of 2008, the Levaquin label changed with regard to tendon injuries. The new labels were not a “black box.” The new labels continued to bury the tendon warnings in a list of potential side effects that are less frequent and less severe. The new labels did not warn of Levaquin’s greater tendon toxicity as compared to the other fluoroquinolones available in the U.S. market.