Sokolove Success Blog – Our Perspective on Legal News that Matters

It’s supposed to help with your strep throat, but could a widely used antibiotic instead harm your liver?

Health authorities in Canada think so and have raised new concerns about popular antibiotic Avelox and possible increased risks of liver failure. In March, Health Canada (the Canadian equivalent of the US Food and Drug Administration) notified health care professionals and patients of changes to the labeling information for Avelox in Canada.  A safety review by the agency concluded that Avelox may be associated with the rare but potentially life-threatening risk of liver injury, including liver failure.

Avelox (moxifloxacin) is a prescription drug belonging to a class of antibiotics called fluoroquinolones. According to Bayer, the manufacturer, over 40 million patients worldwide have been treated with Avelox for a broad range of bacterial infections, including respiratory infections.

The Canadian report is not the first sign of trouble for Avelox.  In fact, there have long been concerns about whether fluoroquinolones contribute to tendon injuries, such as those experienced by our Levaquin clients. We have been engaged with these drugs since 2008 when the FDA issued a black box warning for the increased risk of tendinitis and tendon rupture associated with them.  Interestingly, reports of tendon-related issues had been reported for more than a decade, prompting a series of labeling revisions that finally culminated in the black box warning.

The same pattern seems to be emerging with respect to the risk of liver injury and Avelox.  In 2007, Bayer updated the labeling for Avelox in Europe to reflect this risk and sent a “Dear Doctor” letter to European physicians to draw attention to the change in early 2008.  Now Health Canada has stepped in and required the change in Canada.

Yet Avelox labeling remains unchanged in the U.S.  That doesn’t seem to make much sense, and it certainly could open the company up to liability claims should Americans be injured as a result of the product.

We’re continuing to monitor developments with this drug. If you are interested in working with us on cases related to Avelox or other fluoroquinolones, drop me a line.