November 19, 2014 — ABC15 News reports that at least two citizens’ petitions are asking the FDA to change the label on Levaquin to include new safety information about mitochondrial toxicity and psychiatric side effects.
One petition (PDF) is also asking for new warnings about a long list of psychiatric side effects, ranging from depression to hallucinations.
The other petition (PDF) is calling for warnings about “mitochondrial toxicity,” including neurodegenerative diseases and developmental disorders of the brain, optic neuropathy, neuropathic pain, hearing loss, muscle weakness, cardiomyopathy, and lactic acidosis.
The petitions cite thousands of reports of psychiatric adverse events. An FDA review in 2013 that raised the possibility of mitochondrial toxicity.
This is not the first time the makers of Levaquin have been accused of downplaying risk information. In 2013, the FDA ordered stronger warnings about peripheral neuropathy, a rare but serious type of nerve damage that can occur rapidly and cause permanent complications.
The FDA originally required warnings about nerve damage in 2004. However, they continued to receive reports of serious nerve damage — including patients who were not switched to another antibiotic after showing signs of nerve damage.
In 2001, a study published in the Annals of Pharmacotherapy reported 45 cases of antibiotic-induced nerve damage (including 33 linked to Levaquin). Over half of cases occurred within 72 hours and 58% of patients still had symptoms after one year.
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