A woman from Hawaii has filed an Avelox lawsuit in Pennsylvania federal court, after allegedly developing debilitating side effects due to treatment with the fluoroquinolone antibiotic. Her complaint charges Bayer Healthcare Pharmaceuticals, Merck & Co. Inc., and other defendants with breach of warranty, fraud, liability, negligence and negligent misrepresentation. (Case No. 2:17-cv-01926-LDD)
Avelox (moxifloxacin hydrochloride) was approved by the U.S. Food & Drug Administration (FDA) in 1999, and is currently indicated to treat pneumonia, plague, and other serious bacterial infections. According to her April 27th filing in the U.S. District Court, Eastern District of Pennsylvania, Linda Rodriguez’s exposure to the antibiotic allegedly resulted in weakness, loss of balance and other debilitating injuries. She claims the drug’s manufacturers failed to inform the public about side effects that may accompany treatment with Avelox.
In 2011, roughly 23.1 million unique patients received a dispensed prescription for an oral fluoroquinolone from an outpatient pharmacy. According to the FDA, ciprofloxacin (Cipro), levofloxacin (Levaquin), or moxifloxacin (Avelox) accounted for 70%, 28%, and 9% of the total number of patients, respectively. Since their introduction, however, fluoroquinolone antibiotics have been linked to a range of debilitating side effects, including tendon injuries, peripheral neuropathy, and central nervous system complications. Fluoroquinolone labels have undergone several modifications over the years to reflect these risks.
Most recently, the FDA warned that systemic fluoroquinolones (administered orally or via injection) should not be prescribed to treat acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections when other treatment options are available. The FDA acted after a review confirmed that the antibiotics may cause disabling and potentially permanent complications affecting the tendons, muscle, joints, nerves, and central nervous system. The agency also ordered fluoroquinolone manufacturers to highlight these risks in the black box warning included on their labels.
Levaquin, Cipro and Avelox are currently the subject of hundreds of lawsuits involving peripheral neuropathy, most of which are pending in a multidistrict litigation now underway in the U.S. District Court, District of Minnesota. Plaintiff’s claim that the drugs’ manufacturers were long aware of their potential to damage the peripheral nervous system, yet downplayed this risk and failed to issue appropriate warnings to patients and doctors. They further assert that current label warnings regarding peripheral neuropathy remain “inadequate and confusing” and do not accurately describe the true nature of this risk.
Fluoroquinolone labels were initially modified to include mention of peripheral neuropathy as a possible side effect in 2004. However, the FDA requested further modifications in August 2013, after a review determined that the existing peripheral neuropathy warnings were inadequate. At that time, a statement regarding the potential for the rapid onset of irreversible peripheral neuropathy was added to the labeling, while wording suggesting that the condition was “rare” was removed.