FDA Issues New Guidelines for Levaquin, Other Fluoroquinolone Antibiotics
The U.S. Food & Drug Administration (FDA) has issued new guidelines for the use of Levaquin and other fluoroquinolone antibiotics. In a Drug Safety Communication issued on May 12th, the agency advised that fluoroquinolones should not be used to treat sinusitis, bronchitis and uncomplicated urinary tract infections, after an FDA review found that systemic use of the drugs can cause potentially debilitating and permanent side effects.
The fluoroquinolone class includes popular antibiotics like Levaquin, Cipro and Avelox, as well as a number of generic brands. The medications have been on the market for nearly three decades. In 2014, some 36 million prescriptions were written for the antibiotics. In November, an FDA advisory panel recommended stronger safety warnings for fluoroquinolone drug labels.
According to the FDA, serious fluoroquinolone side effects can involve the tendons, muscles, joints, nerves, and central nervous system. These complications can occur together, and they may prove permanent in some patients. The agency is now requiring that the drug labels and Medication Guides for all fluoroquinolone antibiotics be updated to reflect this new safety information. Those modifications include a new boxed warning that states the serious side effects of the medicines generally outweigh the benefits for people with sinusitis, bronchitis and uncomplicated urinary tract infections, if patients have other treatment options.
Complications Associated with Fluoroquinolone Antibiotics
This is not the first time Levaquin and other fluoroquinolone antibiotics have attracted scrutiny from the FDA. In 2008, the agency ordered that a boxed warning be included on the drug’s labels regarding the potential for serious tendon injuries, including tendon ruptures. In 2013, the FDA required fluoroquinolone manufacturers to strengthen existing label warnings regarding a serious form of nerve damage called peripheral neuropathy. According to the agency, the previous wording did not adequately describe the rapid onset of symptoms, or the fact that peripheral neuropathy associated with fluoroquinolones could be permanent.
Court records indicate that more than 300 peripheral neuropathy lawsuits are now pending against the manufacturers of Levaquin, Cipro and Avelox in the U.S. District Court, District of Minnesota. A multidistrict litigation was established in that jurisdiction last year, in anticipation that hundreds of product liability cases involving the medications would ultimately be filed in U.S. courts.
Levaquin lawsuits and other fluoroquinolone claims involving peripheral neuropathy continue to be evaluated by the attorneys at Bernstein Liebhard LLP. To learn more, please contact our office by calling 877-779-1414.