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Johnson & Johnson allegedly withheld important information about the risk of irreversible peripheral neuropathy associated with Levaquin, according to allegations raised in a product liability lawsuit brought earlier this week by a California man left with the debilitating form of nerve damage after using the popular antibiotic several years ago.
The complaint (PDF) was filed by Wyatt Patterson in the U.S. District Court for the District of New Jersey on December 6, indicating that the global drug maker and its Janssen Pharmaceuticals subsidiary knew about the link between Levaquin and nerve damage for years, yet failed to warn the medical community or users of their antibiotic that they may be left with irreversible peripheral neuropathy.
Patterson indicates that he was prescribed Levaquin in 2013, and used the antibiotic as directed. However, he began to experience symptoms of nerve damage shortly afterwards, and was diagnosed with peripheral neuropathy, which continues to cause him to suffer problems long after his last use of the drug.
Levaquin is part of a widely used class of antibiotics, known as fluoroquinolones, which also includes Avelox and Cipro. While the medications have been prescribed for a variety of different infections in recent years, use of the antibiotics has been curtailed over the past year as more information has become available about the risk of peripheral neuropathy and other health problems linked to the drugs.
At the time Patterson was prescribed Levaquin, warnings mentioned that users may experience nerve damage. However, the complaint indicates that the warnings provided false and misleading information for consumers and the medical community, suggesting that the reports of nerve damage were rare and temporary.
“The truth, however, is that the onset of irreversible peripheral neuropathy is often rapid and discontinuation of the drug will not ensure that the peripheral neuropathy is reversible,” the lawsuit states. “Though this injury can be significant and debilitating, the language regarding the ‘rare’ risk of peripheral neuropathy was buried at the bottom of a long list of adverse reactions that were included on the Levaquin label, the language was in no way highlighted for the benefit of prescribing physicians and patients.”
In August 2013, the FDA required the makers of Levaquin and other fluoroquinolones to provide stronger warnings about the peripheral neuropathy risk with the antibiotics, adding information to the label for the first time that suggested problems may last for months or years after an individual stops taking the drug. The new label now warns patients to contact their doctors and consider switching to a different class of antibiotics if they experience symptoms of peripheral neuropathy. The FDA also no longer allows the drug manufacturers to claim that the condition is rare on the warning labels.
The case filed by Patterson joins more than 400 similar Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits filed throughout the federal court system over peripheral neuropathy problems allegedly caused by the antibiotics.
Given the side effects linked to the antibiotics, the FDA issued a new drug safety communication in May 2016, urging doctors not to prescribe fluoroquinolones for many common infections that are uncomplicated and have other available treatment options, indicating that the potential risks outweigh the benefits. The federal regulatory agency considered available information on the risk of peripheral neuropathy, tendon ruptures, retinal detachments and other health concerns linked to the drugs at that time.
More recently, research has also suggested that fluoroquinolones may cause severe collagen degradation issues that impact the aorta. As a result, a growing number of aortic aneurysm lawsuits and aortic dissection lawsuits are also being pursued by former users of Levaquin and Avelox, alleging that the painful and potentially life-threatening complication may have been avoided if proper warnings had been provided to users of the antibiotics.