May 27, 2015 — Law360 reports that a woman who was diagnosed with peripheral neuropathy (permanent nerve damage) after taking Avelox has filed a lawsuit against the manufacturers for inadequately warning about the side effect.
The lawsuit (PDF) (Case No. 150502686) was filed in the Philadelphia Court of Common Pleas on May 22. The plaintiff, Jacqueline Whiters, is a resident of Pennsylvania who took Avelox in 2012 and 2013.
According to the lawsuit, drug-makers Merck & Co. and Bayer were negligent for failing to warn about the risk of peripheral neuropathy:
“Though this injury can be significant and debilitating, the language regarding the “rare” risk of peripheral neuropathy was buried at the bottom of a long list of adverse reactions that were included on the Avelox label.”
Evidence linking fluoroquinolone antibiotics began surfacing in the early 1990s. The FDA put drug-makers on notice in 2002, and in 2004 the label was updated to include peripheral neuropathy at the end of a long list of fine-print side effects. This information was “in no way highlighted” for doctors or patients, and did not include any warnings about the possibility of permanent nerve damage.
The FDA ordered drug-makers to strengthen warnings about the risk in August 2013. According to the Drug Safety Communication, this serious nerve damage may occur soon after these drugs are taken (within hours or days) and may be permanent.