The U.S. Food and Drug Administration (FDA) announced Thursday that it will require manufacturers of fluoroquinolone antibacterial drugs, a commonly used class of antibiotics, list new warning labels that explicitly outline the serious and damaging side effects.
The medications, which include well-known brand names like Bayer AG’s Cipro and Johnson & Johnson’s Levaquin, boast side effects so disabling that they outweigh the benefits, federal officials said. Patients are often given these drugs to treat sinusitis, bronchitis, or urinary tract infections, and as a result may damage tendons, joints, and the central nervous system. If this is the case, patients might feel a “pins and needles” tingling or pricking sensation, confusion, and/or hallucinations.
“The FDA takes seriously its responsibility to protect the health of the American public through the review of safety, effectiveness and quality of medical products for patients,” the agency said in a prepared release. “The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of fluoroquinolones and will keep health care providers and the public informed of new information.”
Fluoroquinolone drugs are prescribed to more than 23 million patients, and they work by killing or stopping the growth of bacteria that can cause illness. However, because of its serious side effects, officials recommend fluoroquinolone “be reserved for those who do not have alternative treatment options.”
The FDA encourages patients to contact their healthcare provider if they experience any negative outcomes while taking fluoroquinolone medicine; at which point the FDA recommends doctors switch patients to a non-fluoroquinolone antibacterial drug.
Bayer, the makers of fluoroquinolones Avelox and Cipro, released a statement following FDA’s safety announcement, saying patient safety is a priority and they “will carefully review the information that FDA posted today and will continue to work closely with the agency on this topic,” according to WRIC News.
Quinolone Vigilance Foundation, a non-profit foundation that fights for patient safety, issued a statement applauding the FDA in their efforts to minimize harm to patients.
“Fluoroquinolone antibiotics are too risky for routine infections such as sinus infections, urinary tract infections, and bronchitis, and should only be used to treat life threatening infections,” the organization said. “When the risk of a treatment for infection outweighs the benefits, changes need to be made at the highest levels to protect the health, safety, and lives of patients.”
The agency’s decision is on the heels of a 2013 study conducted by the FDA’s Office of Surveillance and Epidemiology, where investigators found “an association between fluoroquinolone antibiotic use and disabling peripheral neuropathy,” weakness, numbness, and pain that results from nerve damage. Fluoroquinolone has also been linked to 3,000 deaths and 200,000 complaints of serious side effects. What’s more, past research has shown that one in three antibiotics prescribed in the U.S. is unnecessary.