Investigators warned that some serious side effects were not included in the label. For example, an FDA study from 2013 found a possible link to cell damage known as mitochondrial toxicity.
Last year, Dr. Charles Bennett, a drug researcher at the University of South Carolina, petitioned the FDA to add warnings about mitochondrial toxicity. He explained that mitochondria are the “gas tank” of the body and without them, “your body cannot function.”
Symptoms of mitochondrial toxicity include muscle weakness (myopathy) and elevated levels of lactic acid. Some people develop lactic acidosis and symptoms like nausea, vomiting, severe fatigue, weight-loss, rapid breathing, muscle aches, and more.
Another severe side effect of mitochondrial toxicity is peripheral neuropathy — nerve damage that causes numbness, tingling, weakness, or pain in the fingers and toes.
The label on Levaquin has carried warnings about peripheral neuropathy since 2004. In August 2013, the FDA issued a Safety Communication to emphasize that nerve damage from Levaquin could occur rapidly (after just a few doses) and cause permanent side effects.
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