In July 2016, the U.S. Food and Drug Administration (FDA) approved safety labeling changes for a class of antibiotics called fluoroquinolones.
Fluoroquinolones are prescribed to kill infection-causing bacteria or to stop them from growing. FDA-approved drugs in this class include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), ofloxacin, and Gemifloxacin (Factive).
The FDA ordered safety labeling changes for these drugs because of risks that were uncovered under an FDA safety review. Research has shown an association between fluoroquinolone use, whether in oral form or by injection, and severe and sometimes permanent side effects including damage to tendons, muscles, joints, nerves, and the central nervous system.
These drugs can sometimes cause such severe injuries to patients that experts have coined a new term to describe the condition, FQAD, which stands for fluoroquinolones-associated disability. To meet the diagnosis requirements for FQAD, a patient must have been prescribed a fluoroquinolone drug and then develop symptoms relating to at least two different body parts or systems, including the peripheral nervous system, musculoskeletal system (including tendon rupture), cardiovascular system, skin, sensation, and psychiatric.
While it may still be appropriate for physicians to prescribe drugs like Levaquin, Cipro, or other fluoroquinolones, the FDA has instructed that they should be limited for use in patients for whom there are no alternative treatment options.
For example, the FDA has found that the risk of serious side effects of using Avelox, Factive, or other fluoroquinolones generally outweighs the benefits for patients with illnesses including bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections (UTI).
This is not the first time that the FDA is added so-called black box warnings related to this class of drugs. In July 2008, the FDA warned of an increased risk of tendinitis and tendon rupture from fluoroquinolones like Levaquin and Cipro. In November 2015, the FDA warned about irreversible damages when these medications were used to treat a list of uncomplicated infections. In May 2016, the FDA released a drug safety communication recommending fluoroquinolone use only when there is no other treatment option, and described the potential side effects as permanent and disabling.
In my experience, as a Houston, Texas medical malpractice lawyer, many prescribing healthcare providers, including doctors, nurse practitioners, and physician assistants, continue to prescribe fluoroquinolones, despite the FDA warnings. It remains unclear to me why some prescribers continue to do so, but I suspect that it is because it is merely an ill-advised habit. Based on FDA recommendations, though, this type of healthcare is negligent, violates the standard of care, and dangerous.
Before prescribing any medication, doctors, and other providers should consider the risks and benefits of the medication, as well as alternative treatment options.
If you or a loved one has been prescribed a fluoroquinolone medication, like Cipro or Levaquin, and has experienced serious, permanent complications, call Painter Law Firm, in Houston, Texas, at 281-580-8800, for free consultation about your potential case.
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Robert Painter is an attorney at Painter Law Firm PLLC, in Houston, Texas. He is a former hospital administrator who represents patients and family members in medical malpractice and wrongful death lawsuits against hospitals, doctors, surgeons, anesthesiologists, and other healthcare providers. In 2017, H Texas magazine named him as one of Houston’s top lawyers. In the same year, the Better Business Bureau recognized Painter Law Firm with its Award of Distinction.
