Avelox Nerve Damage Lawsuit Filed Over Failure to Warn About Antibiotic Risks

According to allegations raised in a product liability lawsuit recently filed against Bayer and Merck, side effects of Avelox caused a New York woman to suffer severe and permanent nerve damage, indicating that the drug maker failed in it’s duty to warn consumers and the medical community about the risk of peripheral neuropathy associated with the popular antibiotic.

The complaint (PDF) was filed by Denise Gubitosi in the U.S. District Court for the Eastern District of Pennsylvania on August 5, indicating that the antibiotic Avelox is “defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce, and lacked proper warnings and directions as to the dangers associated with its use.”

Gubitosi was prescribed Avelox in April 2013, and claims to have developed irreversible peripheral neuropathy, a form of nerve damage. Her lawsuit claims that the manufacturers knew about the potential Avelox nerve damage risk as early as 2001, a decade before it was prescribed to her, but did not issue a proper warnings about the permanent problems experienced by many users until the FDA mandated a label update in August 2013, months after she’d already taken it.

Avelox (moxifloxacin) was introduced in 1999, as a new member of the popular class of antibiotics known as fluoroquinolones, which also includes the widely used drugs Cipro and Levaquin. While all members of the class have contained warnings about reports of nerve damage, Gubitosi indicates that the warnings misleadingly indicated that the problems were rare and failed to disclose that users may suffer peripheral neuropathy that is permanent.

Peripheral neuropathy involves damage to the nerves that may impair sensation, movement and other aspects of health. Symptoms may include pain, burning, tingling, numbness, weakness and sensitivity to light touches, temperature and motion in the arms and legs.

Gubitosi’s case joins a growing number of Avelox peripheral neuropathy lawsuits being filed by individuals nationwide, as well as Levaquin lawsuit and Cipro lawsuits, which all raise similar allegations that the drug makers withheld information about the link between nerve problems and the antiobiotics.

In August 2013, the FDA required the makers of all fluoroquinolones to provide stronger warnings about the peripheral neuropathy risk from the antibiotics, indicating problems may last for months or years after an individual stops taking the drug. The new label now warns patients to contact their doctors and consider switching to a different class of antibiotics if they experience symptoms of peripheral neuropathy.

Gubitosi presents claims of strict liability, failure to warn, negligence, breach of warranty, fraud, negligent misrepresentation, and fraudulent concealment. She is seeking both compensatory and punitive damages.

Other Avelox Health Risks

Avelox and other fluoroquinolones have seen a slew of new warning labels added in recent months, in addition to peripheral neuropathy, raising questions as to whether the drugs were properly researched before being placed on the market.

The most recent was last month, when the FDA issued a drug safety communication indicating that additional information will be added to the existing “black box” label warning already carried by the drugs, which is the strongest label warning the agency can require.

The warning for Levaquin, Avelox, Cipro and other fluoroquinolone-based antibiotics will now indicate that the drugs should not be used for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, unless there are no other treatment options. The FDA warns that the risk of side effects from Levaquin and similar antibiotics outweigh the benefits in most of those cases, due to the risk of permanent side effects that can affect the nervous system, joints, tendons and muscles.

The label warnings come amid emerging data about a new risk associated with use of the drugs, after a recent study found users may also face an increased risk of suffering an aortic aneurysm or aortic dissection.

Aortic aneurysm is a painful and potentially serious condition involving a bulge in the aorta, where the walls of the artery have weakened. They can cause severe chest pain, as well as carry the risk of rupturing. Aortic dissections are similar, but potentially more serious and life-threatening condition, involving degradation within the layers of the aorta. Both pose a serious health risk and usually require invasive surgery to treat.

In October 2015, only weeks before the FDA advisory meetings on fluoroquinolones, a study published in the medical journal JAMA Internal Medicine found that current use of Levaquin, Avelox or a similar antibiotic was associated with a two-fold increased risk of suffering an aortic aneurysm or dissection injury.

Researchers suggested that the same side effects that cause the antibiotics to degrade tendons and other connective tissue in the body may result in problems with aortic dissections and aneurysms. It does not appear that these findings were considered by the FDA advisory panel convened last year to evaluate the safety of fluoroquinolones, or weighed in the recent FDA decision to add new warnings that called for restricted use of the medications.

It is possible that these concerns could lead to yet another FDA safety review, and, if verified, could lead to additional label warnings, or potentially even a recall for Levaquin, Avelox, Cipro and other fluoroquinolones, if the agency determines that the cumulative risks outweigh the potential benefits over other available treatments.

In late June, the Institute for Safe Medication Practices (ISMP) issued a report indicating that Levaquin and Cipro were linked to a large number of adverse event reports in 2015, which warned that the drugs were linked to disabling side effects.

The ISMP reports that there were 489 cases of persistent adverse side effects linked to the use of Levaquin that were reported to the FDA last year, and 366 cases of persistent adverse effects linked to Cipro. In this case, persistent effects is defined as those effects that continue even after the patient has stopped taking the drug.