September 22, 2014 — A consumer safety organization has submitted several petitions to the U.S. Food and Drug Administration (FDA) demanding stronger warnings about peripheral neuropathy (nerve damage), mitochondrial toxicity, and psychiatric adverse events.

The Citizen Petitions were filed by the Quinolone Vigilance Foundation (QVF), a non-profit organization focused on fluoroquinolone toxicity. Drugs in this class include Levaquin, Avelox, Cipro, and more.

The group wants a Black Box warning that will emphasize psychiatric adverse events. These events are “essentially hidden under the heading, ‘Central Nervous System Effects,” where “most people would not look.” They want a Black Box warning for toxic psychoses, hallucinations, paranoia, suicidal thoughts or acts, loss of consciousness, delirium, depressed level of consciousness, amnesia, coma, and memory impairment.

The group also wants the FDA to investigate a possible link between Levaquin (levofloxacin) and “mystery illnesses” in California children who developed paralysis and polio-like symptoms. A petition was  sent to the FDA Pediatric Advisory Committee with requests to reconsider the use of Levaquin in children.

Fluoroquinolones are broad-spectrum antibiotics that are supposed to be reserved for serious infections (sepsis, drug-resistant blood infections, hospital-acquired pneumonia, etc.), but they are increasingly being prescribed to treat sore throats and other minor ailments. The most popular drugs in this class include Levaquin, Cipro, and Avelox.

Last year, the FDA decided to strengthen warnings about the risk of peripheral neuropathy — but they did not add a Black Box. The FDA emphasized that permanent nerve damage can occur rapidly (within days) and cause permanent side effects like nerve pain, muscle weakness, and more.


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