The U.S. Centers for Disease Control (CDC) is now warning doctors to prescribe fluoroquinolone antibiotics – a class of drugs that includes Levaquin, Avelox and Cipro – only when “absolutely necessary” because of their potential to cause serious adverse events.
The CDC warning follows the release of data suggesting that the drugs are often used to treat conditions that do not require antibiotic treatment or those with a different recommended first-line therapy,
According to a report published in Clinical Infectious Diseases, 1.5 million fluoroquinolones were prescribed to adults during ambulatory care visits in 2014. Genitourinary conditions (24.5%) and respiratory conditions (21.6%) accounted for the majority of these prescriptions.
Nearly 20% of fluoroquinolone prescriptions were written for patients with uncomplicated urinary tract infections or viral respiratory infections and bronchitis that don’t require antibiotic treatment. What’s more, fluoroquinolones were the MOST COMMONLY prescribed antibiotic for uncomplicated UTIs (40.3%) and the third most commonly prescribed antibiotic for respiratory conditions.
“Fluoroquinolones’ side effects can involve tendons, muscles, joints, nerves and the central nervous system, or could lead to life-threatening Clostridium difficile infection, which causes diarrhea that can lead to severe colon damage and death,” the CDC said in a statement responding to the report. “Because of these serious side effects, in 2016, the [U.S. Food & Drug Administration (FDA)] issued a warning advising health care providers to not use fluoroquinolones for conditions for which alternative and effective treatment is available and when the potential risks outweigh the benefits.”
The FDA warning followed an agency review that suggested fluoroquinolone antibiotics could cause potentially permanent side effects involving the tendons, muscles, joints, nerves and central nervous system. At the time, the FDA required fluoroquinolone manufacturers to add this information to the Black Box Warning included with the drugs’ prescribing information. A Black Box Warning is the most urgent type of safety notice.
That warning was only the most recent FDA alert to focus on fluoroquinolone antibiotics. In August 2013, the agency ordered the drugs’ manufacturers to modify label information regarding their potential to cause a serious nerve disorder called peripheral neuropathy. While mention of the condition had been added to the prescribing information in 2004, the FDA determined that the labels did not reflect the possible rapid onset of the condition, or the potential for permanence.
In 2008, information regarding the potential for tendon damage – including ruptures and tears of the Achilles tendon – was added to the drugs’ Black Box Label.
Hundreds of people are currently pursuing peripheral neuropathy lawsuits against the manufacturers of Cipro, Levaquin and Avelox. Among other things, plaintiffs accuse the drug companies of downplaying this risk and failing to provide doctors and patients with adequate safety warnings.
Claims have also been filed on behalf of patients who suffered aortic injuries – including aortic aneurysm and aortic dissection – allegedly associated with the use of Cipro, Avelox and Levaquin.