LawyersandSettlements.com Interviews Lead Author On Study Showing Link Between Fluoroquinolone-Based Antibiotics And Nerve Damage

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A year after the US Food and Drug Administration (FDA) addressed the subject of a label change for fluoroquinolones that pose a risk for Peripheral Neuropathy (PN), a new Canadian study suggests the risk for PN among users of fluoroquinolone-based antibiotics is double that of non-users. LawyersandSettlements.com now interviews the lead author of the study, Dr. Mahyar Etminan, PharmD. of the University of British Columbia.

It was in 2008 that the FDA mandated a black box warning on the prescribing labels of some fluoroquinolone-based antibiotics* with regard to the potential for chronic tendonitis. Chronic, because of the possibility of an open-ended continuance of the condition long after the medication was stopped. Now, a new study** raises concern about another potential side effect of fluoroquinolone use--peripheral neuropathy, or PN – a condition characterized by sensations of tingling, hyper-sensitivity to touch, buzzing, or a burning sensation in the arms or legs, amongst other symptoms.

Last August, the FDA issued a safety communication*** over the possibility of PN. Now, a large Canadian-based epidemiologic study * suggests the risk for PN could be twice that of non-users of fluoroquinolone-based antibiotics.

The lead author of the study notes that the potential for PN remains relatively rare, “but in terms of the relative risk,” said Dr. Mahyar Etminan, PharmD. of the University of British Columbia, in comments to LawyersandSettlements.com senior writer Brenda Craig, “it doubles the risk between users and non-users,” of oral fluoroquinolones.

The fluoroquinolone class of antibiotics are a group of infection-fighters that have been around since they were first discovered in the 1960s†. Ciprofloxacin (Cipro), levofloxacin (Levaquin) and moxifloxacin (Avelox) are three drugs within the fluoroquinolone class†. Dr. Etminan noted to LawyersandSettlements.com that symptoms of PN amongst the three oft-prescribed antibiotics do not differ significantly.

The study, currently appearing in the online issue of Neurology and to appear in print September 15th, “is the first large epidemiologic study. It confirms a previous data mining study and the conclusions of the FDA based on adverse event reporting,” says Etminan. “Different antibiotics work in different ways,” Dr. Etminan continues. “This specific type goes into the cell and changes the DNA of the bacteria. We think that although it is designed to work on bacteria, we think it is possible that human DNA is also changed. That may be how we are getting reports of all these side effects, from tendon rupture to kidney failure and liver damage to peripheral nerve damage.”

While Etminan noted that only men were addressed in the study, although Etminan believes women would be just as susceptible. “These drugs affect muscle and nerves,” Etminan said, in comments to LawyersandSettlements.com. “We don’t think the risk differs in women. It may be a little bit higher or lower but there is no reason to believe this won’t be the same in women.”

The cohort used to facilitate the study was a large US-based cohort controlled for confounding factors, such as diabetes. The purpose was to determine if use of the fluoroquinolone class of antibiotics linked to nerve damage in otherwise healthy males.

The researchers concluded that it can, and does. While rare, the risk is still twice that for users of fluoroquinolones over non-users. “Current users, especially new users of FQs, are at a higher risk of developing PN,” noted the researchers in their study conclusions. “Despite the increase in the use of FQs, clinicians should weigh the benefits against the risk of adverse events when prescribing these drugs to their patients.” **

Symptoms of PN†† are not confined to those noted above. Symptoms can include electrical zaps, pain in the mouth, lips, teeth, facial pain and muscle twitching. In 2013***, the FDA noted an increase in reports to its Adverse Event Reporting System (AERS) with regard to symptoms suggesting PN from fluoroquinolone-based antibiotic use.

** “Oral fluoroquinolone use and risk of peripheral neuropathy”, Mahyar Etminan, PharmD,
James M. Brophy, MD, PhD and Ali Samii, MD, August 22, 2014, doi: 10.1212/WNL.0000000000000846Neurology 10.1212/WNL.0000000000000846

*** “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection”, FDA.gov, August 15, 2013, http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm

† “Development of the Quinolones”, Journal of Antimicrobial Chemotherapy, Monique I. Andersson and Alasdair P. MacGowan, 2003, http://jac.oxfordjournals.org/content/51/suppl_1/1.full.pdf

††”Peripheral Neuropathy Fact Sheet”, National Institutes of Health, National Institute of Neurological Disorders and Stroke, http://www.ninds.nih.gov/disorders/peripheralneuropathy/detail_peripheralneuropathy.htm

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