Los Angeles, CARecent concerns about Levaquin side effects have prompted some critics to call on the Food and Drug Administration (FDA) to take stronger action regarding Levaquin. A recent report by ABC10 News highlights some of the concerns medical professionals and patients have about the drug.
According to ABC10 News, some researchers are concerned that Levaquin has more serious side effects than those mentioned on the drug’s label. Specifically, they are concerned about depression, hallucinations and mitochondrial toxicity, which indicate the drug could actually have an effect on a patient’s cells. Studies have reportedly been undertaken at UC San Diego and University of Rochester to look into some of the side effects that could be linked to Levaquin.
Levaquin is an antibiotic in a class known as fluoroquinolones. Although they are lifesaving drugs, some experts believe they are overprescribed, putting many patients at risk for serious side effects. Further, in some cases, they are used for fairly minor infections that may not require a strong antibiotic, so the risks might outweigh the benefits. Levaquin currently carries a black box warning about the risk of tendon rupture.
The Southern Network on Adverse Reactions (SONAR) submitted a Citizen Petition (also found online at www.regulations.gov) to the FDA regarding Levaquin. In it, the organization requested a black box warning about the possible risk of mitochondrial toxicity, a label change to include the risk of “possible mitochondrial toxicity,” and the issuing of a “Dear Doctor” to inform physicians about the label changes.
The petition notes that from November 1, 1997 to February 3, 2011, the FDA Adverse Event Reporting System received reports of 79,328 reactions linked to Levaquin. Because the events reported to the FDA are estimated to be between one and 10 percent of actual events, SONAR estimates that the actual incidence of adverse events is between 793,280 and 7,932,800.
SONAR acknowledges that Levaquin may in some cases be the most appropriate medication, making some of the adverse events unavoidable. In other circumstances, however, if there had been Warnings, including a Black Box Warning, about the potential for Levaquin “Mitochondrial Toxicity,” some physicians may not have prescribed Levaquin for some patients.
Levaquin (known generically as levofloxin) is made by Johnson & Johnson.
A lawsuit has been filed against Johnson & Johnson alleging the company failed to warn about the risk of peripheral sensorimotor neuropathy. That lawsuit is Grossman v. Johnson & Johnson et al, Case No. 3:2014cv03557.
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