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Part of drug class fluoroquinolones, Avelox was approved by the FDA in 1999 to treat such bacterial infections as sinusitis, chronic bronchitis, and pneumonia. Studies over the past 15 years, however, reveal a correlation between the antibiotic, generically known as moxifloxacin hydrochloride, and two potentially-permanent conditions – nerve damage and tendon ruptures.
In response, plaintiffs have come together to file multi-district litigation against manufacturer Bayer.
The first reports of nerve damage go back to a small study released in 2001, published in the Annals of Pharmacotherapy. At the time, researchers analyzed 45 cases of patients using fluoroquinolones, including Avelox, and the conditions that developed. According to their findings, symptoms occurred within a week for 84 percent of all patients, and continued for a year for 59 percent of the group.
By 2004, the FDA required Bayer to include a warning with Avelox. The drug manufacturer, on the other hand, played down the side effects at the time by claiming that in “rare cases” did patients experience sensory nerve damage. Permanent nerve damage – another potential side effect – wasn’t mentioned.
In 2013, the FDA required that all fluoroquinolones, including Avelox, carry a stronger warning – one that further mentioned risks of developing peripheral neuropathy, a condition in which one or more peripheral nerves are damaged. These nerves transmit signals from the brain and spinal cord to other parts of the body. As well, the statement was to include information about rapid nerve damage and permanent complications.
In 2014, Neurology published a study finding that people who took fluoroquinolones had double the rate of developing peripheral neuropathy. Researchers, in examining 6,226 cases and 24,904 control subjects, discovered an 83-percent increased risk of developing peripheral neuropathy in those who took fluoroquinolones, especially if the patient was a first-time user.
If you suspect nerve damage related to Avelox, what are the symptoms?
Peripheral Neuropathy: The motor nerves are affected. Signs may be muscle weakness, spasms, and coordination issues. A patient may find his or her position, balance, fine motor skills, or walking compromised.
Sensory Nerves: The patient experiences decreased sensation on the skin. Signs may include touch sensitivity, chronic pain, tingling, and numbness.
Other Side Effects
Patients who have taken Avelox have experienced ruptured tendons in the Achilles heel, shoulders, hands, biceps, and thumb. The condition may occur even after the patient has been off Avelox for several months. Those at least 60 years of age, who are undergoing steroid therapy, or who have had kidney, heart, or lung transplants have a greater risk.
Because of the correlation, organization Public Citizen petitioned the FDA to include a Black Box warning. The FDA has since required Bayer to include a statement.
Additionally, Canadian and European drug labels include a disclaimer about potential liver damage. Patients taking Avelox have experienced life-threatening liver injuries or failure, with the condition manifesting as a combination of abdominal pain, loss of appetite, yellowing of the skin and eyes, severe itching, dark urine, and pale stools.
For a newer side effect, a 2013 study revealed an association of eye risks, including retinal detachment, a condition in which the retina separates from the back of the eye. The study examined all fluoroquinolones, including Avelox.
Over 100 million people have taken Avelox orally or intravenously, and the drug continues to remain on the market. However, a lack of thorough warnings has put all patients at risk for developing the above conditions.