September 29, 2014 — Bayer HealthCare, the manufacturer of Avelox, has been hit with a lawsuit from a woman who says the popular antibiotic’s label failed to adequately warn about the risk of peripheral neuropathy (nerve damage).
The lawsuit (PDF) was filed last month in the U.S. District Court for the Northern District of California. The plaintiff, Sherri Kellerman, is a resident of Tennessee who was diagnosed with peripheral neuropathy. She says she would have used another antibiotic if Bayer had properly warned about the risk of peripheral neuropathy.
The lawsuit states:
“Rather than warning patients and physician that the use of Avelox may result in permanent nerve damage, Defendants instead adopted a warning that misleadingly indicated such damage was rare and failed to make any mention of the risk of permanent nerve damage.”
According to the complaint, the label on Avelox was false and misleading between September 2004 and August 2013. The FDA originally required warnings about peripheral neuropathy in 2004, but drug-makers only warned about “rare cases” of sensory nerve damage. They omitted information about permanent nerve damage.
The FDA ordered drug-makers to update warnings in 2013 to include information about rapid onset of symptoms and permanent complications.
Lawsuits claim that Bayer should have known about these risks. Evidence linking fluoroquinolone antibiotics and peripheral neuropathy has been growing since 1992. In 2001, a study described dozens of cases in which symptoms appeared rapidly (within days) and persisted for months.
Last month, Neurology published a study linking fluoroquinolone antibiotics with a doubled risk of peripheral neuropathy.