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Citizen Petitions Want Stronger Warnings on Levaquin Label

Citizen Petitions Want Stronger Warnings on Levaquin Label

November 19, 2014 — The FDA has received two petitions from citizens who are concerned that the label on Levaquin does not include warnings about psychiatric side effects and mitochondrial toxicity, according to ABC15 News.

One petition (PDF) is calling for warnings about toxic psychoses, hallucinations, paranoia, suicidal thoughts or acts, loss of consciousness, delirium, depressed level of consciousness, amnesia, coma, and memory impairment.

The other petition (PDF) wants warnings about mitochondrial toxicity, a side effect that could lead to neurodegenerative diseases, developmental disorders of the brain, optic neuropathy, neuropathic pain, hearing loss, muscle weakness, cardiomyopathy, and lactic acidosis.

Last year, the FDA ordered the manufacturers of Levaquin to add stronger warnings about peripheral neuropathy, a serious type of nerve damage. The warnings emphasized the rapid onset of symptoms and potentially permanent complications.

However, evidence of rapid and permanent nerve damage was first published over a decade earlier. In 2001, Annals of Pharmacotherapy reported 45 cases of antibiotic-induced neuropathy, including 33 linked to Levaquin. In over 80% of cases, symptoms appeared within one week. Nearly 60% of patients still had symptoms after one year.

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The Schmidt Firm, PLLC is currently accepting Levaquin induced injury cases in all 50 states. If you or somebody you know has been diagnosed with nerve damage (peripheral neuropathy), you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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