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Don’t Be a Victim of the FDA’s Delayed Levaquin Warnings: Consult an Attorney
It took the FDA at least a dozen years to respond to public concern about the connection between Levaquin and tendon ruptures. For years, consumer groups, the Illinois Attorney General and others urged the FDA to require the manufacturers of Fluoroquinolone antibiotics, such as Levaquin, to increase their warnings to patients. Yet, the FDA failed to heed these warnings and patients continued to be harmed by these drugs.
When Was the FDA Made Aware that Tendon Ruptures were a Significant Side Effect of Levaquin?
As early as 1996, the national non-profit public interest organization, Public Citizen, urged the FDA to require Fluoroquinolone manufacturers to add additional warnings to their products. The FDA responded to Public Citizen’s 1996 petition by requiring Fluoroquinolone manufacturers to include a warning about tendon ruptures. However, the FDA allowed the drug manufacturers to bury the warning in a long list of possible adverse effects making it difficult for patients to learn about the dangerous side effect of tendon ruptures and to be alert to possible symptoms of the condition.
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In 2005, the Illinois attorney general petitioned the FDA to add a black box warning to drugs such as Levaquin in order to inform patients of the potential risk. Again, the FDA failed to provide an adequate warning.
It wasn’t until July 2008 that the FDA finally required Fluoroquinolone antibiotic manufacturers to include a black box warning on their products.
How Did the FDA’s Failure to Act Effect Levaquin Patients?
Lawsuits currently pending against Ortho-McNeil and its parent company Johnson & Johnson allege that the FDA’s failure to require adequate warnings led to patients suffering injuries. The lawsuits allege that the FDA has yet to provide an adequate warning even since requiring a black box warning in 2008. Specifically, they allege that the current warning is inadequate because it fails to state that there is an increased risk of tendon toxicity compared to the risk presented by other antibiotics.
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What Should Levaquin Patients Who Have Suffered a Tendon Rupture Do Now?
Patients who have suffered a tendon rupture, tendon toxicity or tendonitis while on Levaquin should immediately contact an experienced pharmaceutical litigation attorney. Lawsuits are currently pending against Ortho-McNeil and Johnson & Johnson in state and federal courts. Your attorney can advise you as to whether your case should be joined with current actions or brought separately and will advise you about the potential outcomes of litigation.
