Plaintiffs Charge LevaquinWith Score of Issues

When Levaquin entered the market, warnings about tendon Levaquin side effects were required on all fluoroquinolone labels, but were buried in a long list of potential adverse reactions, the plaintiffs claim. In addition, the warnings did not advise that tendon injury was tripled with fluoroquinolone use in people older than 60 and in those who are on corticosteroid therapy, according to the complaints. In fact, Levaquin manufacturers marketed the drug toward the elderly, especially those with upper respiratory infections who were likely to be chronic corticosteroid users, the suits state. "More disturbingly, Defendants' promotional campaign was themed on Levaquin's excellent safety profile and failed to disclose the risks of tendon injury," the complaints say. Johnson and Johnson and its subsidiary, Ortho-McNeil, are named as defendants because they test and manufacture Levaquin. 

The FDA has received reports of hundreds of individuals who experienced a Levaquin tendon rupture after using Levaquin or one of the other fluoroquinolones. As a result of the inadequate warnings currently provided, the consumer advocacy group, Public Citizen, filed a Levaquin lawsuit in January 2008 as a result of the FDA’s failure to act on a petition they filed in 2006, calling for more detailed information about the risk of Levaquin tendon ruptures to be added to the warning label. In addition to this,
a New York man, Walter Adamashko, filed a Levaquin lawsuit alleging that the drug was defectively designed and incorrectly marketed, which put patients over the age of 60 at greater risk, unknown to those who received the drug.

Levaquin was responsible for 1,044 reports of tendon injuries and 282 reports of tendon ruptures from 1997 through 2005, according to the complaints.Injuries continued to soar as Levaquin's popularity increased, the suits state. Although the black box warning was not been placed on Levaquin's packaging, a revised label was placed on the antibiotic in April 2007. However, the plaintiffs say the label continued to bury warning about tendon risks and did not contain a warning about Levaquin's greater association with tendon toxicity as compared to other fluoroquinlones.  In January 2008, a Levaquin lawsuit was filed against the FDA alleging that their petition had been ignored.