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FDA Petitioned to Expand Label Warnings for Serious Side Effect of Levaquin

Filed August 12th, 2015 F.A. Kelley

Although Levaquin and other drugs in its class carry the Food and Drug Administration’s (FDA) most serious label warnings, a drug researcher at the University of South Carolina says the FDA should expand those warning to include mitochondrial toxicity, another serious and possibly fatal side effect of the fluoroquinolones.

A 2013 Food and Drug Administration (FDA) database obtained by Cleveland television station ABC 5 (WEWS) contains reports of 3,000 deaths and 200,000 side effect complaints related to Levaquin (levofloxacin), Cipro (ciprofloxacin) and other drugs in their class.

Fluoroquinolones are used to treat serious infections such as pneumonia and kidney infections and are powerful enough to have been used to treat anthrax cases. Fluoroquinolone side effects include tendinitis, tendon ruptures, liver damage, diarrhea, heart rhythm changes, blood sugar level changes, and nerve damage to the arms and legs, according to the National Library of Medicine (of the National Institutes of Health). Fluoroquinolones have carried the FDA’s black box warning since 2008 and in 2013 the FDA expanded that warning to include the risk of ruptured tendons and nerve damage.

But the warnings to not include the risk of mitochondrial toxicity, and this is the risk Dr. Charles Bennett of the University of South Carolina says should be added to the label. Bennett, a drug researcher at the University of South Carolina who holds an endowed chair at the Medication Safety and Efficacy Center of Economic Excellence (CoEE). Bennett explains that mitochondria are the body’s “gas tank.” They produce the body’s energy and without mitochondria, “your body cannot function.” Last year Bennett petitioned the FDA to include mitochondrial toxicity in the fluoroquinolone side effects.

Mitochondrial toxicity can cause muscle weakness, peripheral neuropathy (numbness of fingers and toes), and pancreatitis. The most severe symptom is lactic acidosis: a build-up of lactic acid in the tissues leads to loss of energy, organ failure, and eventually death. According to the Mayo Clinic, the brain, heart, liver, muscles, kidneys and the endocrine system most frequently experience damage from mitochondrial toxicity.

It could be another year or more before the FDA makes its decision on the petition for expanded warnings and Bennett says this could cost additional lives, according to WEWS.

Janssen Pharmaceuticals, which makes Levaquin, said the company monitors “the safety and effectiveness of all our medicines,” and “we incorporate new data into our product labels so doctors and patients can make informed decisions.” But reporting of drug side effects to the FDA is voluntary and, according to Bennett, the agency gets only about “one percent of all reports.” Based on the 3,000 deaths noted in the 2013 FDA database, Bennett calculates that the actual number of fluoroquinolone-related deaths could be closer to 300,000, according to WEWS.


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