Petitions Claim Side Effect of Levaquin Not Listed on Label

Petitions Claim Side Effect of Levaquin Not Listed on LabelNovember 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.

Need a Texas Levaquin Lawyer?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Levaquin lawyers for a free lawsuit review.

Free Case Review

Verified 100% Secure Site

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 879-3040.

*
*
*