The antibiotic Avelox, part of the class of drugs known as quinolones, is defective, dangerous to human health, unsuitable to be marketed and sold, and lacking proper warnings and directions as to the dangers associated with its use, an Illinois woman claims in her Avelox lawsuit filed against drug makers Bayer and Merck in January 2015.

In January 2013, Jeanne B.’s doctor prescribed a 10-day course of Avelox. Subsequently, Jeanne developed irreversible peripheral neuropathy, a painful nerve condition that develops as a result of damage to the peripheral nervous system, the Avelox quinolone antibiotic lawsuit explains.

In August of that year, the U.S. Food and Drug Administration (FDA) issued an updated warning alerting consumers of the risk of the rapid onset of irreversible peripheral neuropathy and removed an earlier statement that nerve damage occurred only in rare cases.

“The warning label for Avelox during the period from September 2004 through August 2013 misled plaintiff and her treating physician by incorrectly advising patients and physicians that peripheral neuropathy associated with Avelox was ‘rare’ and failing to mention the possibility that it could result in irreversible nerve damage,” Jeanne’s Avelox quinolone antibiotic lawsuit alleges.

She is seeking both compensatory and punitive damages in her quinolone lawsuit.

According to the National Institutes of Health, the symptoms of peripheral neuropathy can range from numbness or tingling, to pricking sensations (paresthesia), or muscle weakness. Some parts of the body may become abnormally sensitive resulting in an exaggerated sense of touch, known as allodynia.

“In such cases, pain may occur in response to a stimulus that does not normally provoke pain,” according to the NIH. “Severe symptoms may include burning pain (especially at night), muscle wasting, paralysis, or organ or gland dysfunction. Damage to nerves that supply internal organs may impair digestion, sweating, sexual function, and urination. In the most extreme cases, breathing may become difficult, or organ failure may occur.”

Fluoroquinolones, a subset of quinolones, such as Avelox, have long been associated with serious side effects, leading some — Omniflox (temafloxacin), Trovan (trovafloxacin), Raxar (grepafloxacin), Zagam (sparfloxacin) and Tequin (gatifloxacin) — to be removed from the U.S. market, according to the Avelox lawsuit.

When Jeanne began taking Avelox, the warning label cautioning of the “rare” risk of peripheral neuropathy was buried at the bottom of a long list of adverse reactions, according to her quinolone lawsuit, and in no way highlighted the important information for prescribing physicians and patients.

Avelox first received FDA approval in 1999. In 2004, after a scientific review by the federal agency of adverse events concerning Avelox and other fluoroquinolones, the FDA approved an amended Avelox label addressing peripheral nerve damage. The amended label included a detailed statement in the warnings section describing the risk.

Many people have filed peripheral neuropathy lawsuits against drug makers claiming they failed to warn them about peripheral neuropathy, a condition that in some form affects 20 million people in the United States, according to the NIH.

Manufacturers of the popular fluoroquinolones Levaquin and Cipro are the subject of numerous peripheral neuropathy lawsuits.