Fluoroquinolones are a class of antibiotics popularly used to treat respiratory infections, urinary tract infections, and can even treat pneumonia and kidney infections. More than 26 million Americans are prescribed these drugs every year, making it one of the most widely used drugs. However, studies show that these drugs have been linked to more than 3,000 deaths and over 200,000 complaints of serious side effects have surfaced.
Common complications from fluoroquinolones:
These drugs are marketed under a variety of names, including Levaquin, Cipro, Avelox, Noroxin, Floxin, and Factive.
In August 2013, the FDA issued a warning that required manufacturers to include peripheral neuropathy as a risk in all fluoroquinolone product labels, cautioning consumers that nerve damage may be permanent.
In November 2015, an FDA review panel voted overwhelmingly in favor of much stronger label warnings regarding the risk of adverse events such as tendonitis and tendon rupture, prolongation of the QT interval, and peripheral neuropathy. The FDA review panel also identified a “constellation of disabling symptoms” called fluoroquinolone-associated disability (FQAD), based on evaluation of FDA’s Adverse Events Reporting System. A significant number of FQAD cases were reported where patients taking fluoroquinolones exhibited multiple adverse reactions affecting two or more of the following body systems:
Patients having FQAD experienced a long-lasting and profound decrease in their quality of life, as well as their families’. - FDA Advisory Committee
In July 2016, the FDA approved black box warning updates for all fluoroquinolone product labels. The boxed warnings – FDA’s strongest form of warning – caution about the “disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.” Furthermore, the updated safety information warns that the risks of using fluoroquinolones outweigh the benefits in most cases. As such, the boxed warning advises against their use except in cases of serious bacterial infections where there are no alternative treatment options.
Lawsuits have emerged claiming that makers of the drugs failed to disclose known risks of nerve damage and actively marketing the drug as safe despite studies linking to such effects. The Levaquin MDL (multi-district litigation) is active before the U.S. District Court for the District of Minnesota. Lawsuits against Bayer, the maker of Avelox, continue to be filed.
At Kaiser Gornick LLP, one of our experienced product liability lawyers can discuss your options for recovering compensation. Many injured patients face devastating physical, financial, and emotional losses after suffering from permanent damage caused by the drug. We can help you seek damages for economic and non-economic damages stemming from your injuries.