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FDA Fails to Warn about Risks of Levaquin, Reports Show

Aug 3, 2015

Levofloxacin, sold under the brand names Levaquin and Cipro, is an antibiotic in the flouroquinolone family. The drug is widely used to treat serious illnesses such as pneumonia and kidney infections, but recent reports suggest that the public may not be aware of all the risks. ABC5 in Cleveland, Ohio reports that the U.S. Food and Drug Administration (FDA) has not publicly disclosed that Levaquin has been linked to mitochondrial toxicity, based on a 2013 report.

According to the ABC5 investigation, a review of the FDA's adverse event database showed that Levofloxacin has been linked to 3,000 deaths and 200,000 complaints. The FDA placed a black box warning on the drug in 2008 warning of nerve damage and ruptured tendons.

Mitochondria are essentially the power house of the cell and are responsible for cellular respiration. Mitochondrial toxicity is when there is a decrease in the number of mitochondria, which may cause a cell to stop working properly. According to, this condition most frequently causes muscle weakness and soreness associated with lactic acid buildup. Mitochondrial toxicity may cause lactic acidosis, where there are very high levels of lactic acid in the blood. This may cause symptoms such as nausea, vomiting, severe fatigue, weight less, rapid, deep breathing, cramps, muscle aches and numbness or tingling or muscle weakness that rapidly gets worse. Mitochondrial toxicity may also lead to nerve damage, or periperal neuropathy.

Dr. Charles Bennett, a drug safety advocate and the Endowed Chair in Medication Safety and Efficacy for the Center of Economic Excellence at the University of South Carolina, said "People's lives, people's livelihood, the economy - all are at risk," according to ABC5.

"To put it in plain language," Bennett said. "Mitochondria are the gas tank, mitochondria toxicity means there's no gas in the tank and your body really cannot function."

In 2014, Dr. Bennett filed a citizen's petition with the FDA calling for more warnings. The petition was based on the FDA's own 2013 report, according to ABC5.

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