Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research said in the press release, “The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that healthcare providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use.”
A list of FDA approved fluoroquinolones included levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela).
There are other 60 generic versions of the approved drugs also in the market. The required safety labeling changes issued today was based on an in-depth view of FDA’s adverse event reports and case reports published in medical literature.
A review of the literature found an increased incidence of hypoglycemic coma in patients who experienced hypoglycemia resulting from the use of fluoroquinolones.
The mental side effects of these drugs include disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium. The description of these side effects is already there on the labels but is not consistent across all class of the fluoroquinolones and is listed under central nervous system side effects.
The warning requires them to be listed separately and consistent across of class of the fluoroquinolones.
- FDA issued the first boxed warning against fluoroquinolones in July 2008 for increased risk of tendinitis and tendon rupture.
- In February 2011, FDA further added the risk of worsening symptoms for those with myasthenia gravis.
- In August 2013, FDA required that the label should be updated to describe the potential for irreversible peripheral neuropathy (serious nerve damage).
- In 2016, an enhanced warning was issued about the potential permanent side effects on tendons, muscles, joints, nerves and the central nervous system.
The FDA’s press release says, “Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.”
Each patient receiving the fluoroquinolones should receive a medication guide describing all the potential side effects of the drugs.
