Peripheral Neuropathy is a painful form of damage to one or more peripheral nerves—the nerves that transmit information from your brain and spinal cord to all of the other parts of your body, including your arms, legs and organs. Peripheral nerve damage means that this information is disrupted. Peripheral Neuropathy has a number of causes, but it is becoming more common as more people are taking FQ antibiotics such as Avelox.
Avelox Peripheral Neuropathy
Avelox was developed by Bayer AG and approved for sale in the U.S. in 1999. In 2011, over 2.5 million people were given oral or intravenous (IV) Avelox. However, reports of fluoroquinolone antibiotics associated with peripheral neuropathy have been increasing since 1992.
A study published in the Annals of Pharmacotherapy back in December 2001 found that FQ peripheral nerve damage occurred within days of taking the antibiotic and often persisted for months.
Avelox Peripheral Neuropathy Research and Warnings
The Journal Neurology in August 2014 found that people taking fluoroquinolones (FQs), including Avelox, were at a high risk—almost double—of developing peripheral neuropathy (PN). Dr. Mahyar Etminan and other researchers at the University of British Columbia’s Child and Family Research Institute found that users faced an 83 percent increased risk of developing FQ nerve damage, and new users could potentially have double the risk of nerve damage, when compared to those not taking the drugs.
The researchers indicated that doctors should carefully consider whether the benefits outweigh the risks of Avelox and other FQ antibiotics when prescribing them to patients.
The study, which examined 6,226 cases of PN and compared them to 24,904 controls, was published online one year after the FDA issued a drug safety warning (August 15, 2013) indicating that all FQs may carry a risk of peripheral neuropathy. The FDA ordered drug manufacturers, including Bayer, to include information about rapid onset of nerve damage symptoms and permanent complications.
Avelox peripheral neuropathy warning was added to the FDA Safety Announcement with the following information:
Avelox Peripheral Neuropathy Side Effects
- Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones including AVELOX. Symptoms may occur soon after initiation of AVELOX and may be irreversible. AVELOX should be discontinued immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation.
Avelox lawsuits claim that Bayer should have known about FQ nerve damage risks. In August 2014, a lawsuit was filed in the U.S. District Court for the Northern District of California against Bayer HealthCare claiming the label of its antibiotic Avelox failed to adequately warn about the risk of peripheral neuropathy (Case No 3:14-cv-3680). Plaintiff Sherri Kellerman, a resident of Tennessee, was diagnosed with peripheral neuropathy. In the lawsuit, Kellerman says she would have used another antibiotic if Bayer had properly warned about the risk of peripheral neuropathy.
Avelox Peripheral Neuropathy Lawsuits
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 Bayer and other drug makers only warned about “rare cases” of sensory nerve damage and didn’t mention permanent nerve damage, contrary to previous studies indicating otherwise.
Avelox antibiotic tendon ruptures can involve the Achilles heel, shoulder, hand, bicep or thumb. The risk of tendon ruptures is increased in patients older than 60, people who have received kidney, heart or lung transplants, and people on steroid therapy. Tendon swelling and tendon rupture can also occur in patients who do not have any of those risk factors. Furthermore, tendon ruptures can occur up to several months after treatment with Avelox is complete.
Avelox Tendon Rupture
Avelox carries a black box warning alerting patients to the risk of Avelox tendon rupture and tendonitis (tendinitis). The warning came after Public Citizen—a public advocacy group—and the Illinois Attorney General's office petitioned the US Food and Drug Administration (FDA) to place a black box warning on Avelox.
Avelox Side Effects
Avelox has also been linked to an increased risk of liver injury including liver failure. This risk has been reflected on labeling information for the drug in Canada and in Europe.
According to Bayer's website, Avelox has been used to treat 109 million patients worldwide.
Avelox Tendon Rupture Legal HelpIf you or a loved one has suffered a tendon rupture or tendon damage while taking the antibiotic Avelox, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Mar-17-15