A Florida man has become one of the first plaintiffs in the country to file an aortic aneurysm lawsuit involving the antibiotic Levaquin. The complaint, which is currently pending in the U.S. District Court, Middle District of Florida, also claims that the medication caused the Plaintiff to develop permanent peripheral neuropathy, a serious form of nerve damage.
According to the June 8th filing, the Plaintiff was prescribed two courses of Levaquin in December 2007 and January 2008.The complaint blames the medication for a host of side effects he subsequently suffered, including peripheral neuropathy and an aortic aneurysm that required surgery. The plaintiff also continues to suffer from musculoskeletal, neuropsychiatric, sensory (vision or hearing) and skin injuries that he attributes to his use of Levaquin.
The lawsuit claims that Johnson & Johnson and its Janssen Pharmaceuticals unit failed to provide adequate safety warnings to doctors and patients using Levaquin. “Defendants’ failure to adequately warn physicians resulted in: (1) patients receiving Levaquin instead of another acceptable and adequate non-fluoroquinolone antibiotic, sufficient to treat the illness for which patients presented to the provider; and (2) physicians failing to warn and instruct consumers about the risk of long-term peripheral nervous system injuries associated with Levaquin,” the complaint states.
Levaquin and other fluoroquinolone antibiotics are indicated to treat a wide range of bacterial infections. However, the U.S. Food & Drug Administration (FDA) recently added a new boxed warning to the drugs’ labels stating that the their risks outweigh any potential benefits for patients with certain uncomplicated infections when other treatment options are available. Until 2013, label information regarding peripheral neuropathy implied that such problems were rare and generally resolved when the antibiotic are no longer used. However, that is not the case.
Last year, a study published in JAMA: Internal Medicine suggested the use of fluoroquinolones was associated with an approximately 2-fold increase in the risk of aortic aneurysm and aortic dissection within 60 days of exposure. The authors of the study pointed out that drugs like Levaquin are associated with several collagen-related disorders. Collagen is also a major extracellular matrix component of the aortic wall.