More labeled warnings on fluoroquinolones ordered by FDA

Fluoroquinolone warning labels keep getting longer. In 2018 the U.S. FDA ordered stronger cautions about mental health side effects, and severe hypoglycemia causing coma and death.

Mental health disturbances now attributed to fluoroquinolones include:

• Attention disturbances

• Disorientation

• Agitation

• Nervousness

• Short-term memory loss

• Delirium

The risk of hypoglycemic coma now gets a specific mention on the warning label as well. Fluoroquinolones have caused at least 67 cases of life-threatening hypoglycemic coma, with 13 deaths, an FDA report concluded. Levofloxacin was the antibiotic most often given. Actual cases are theorized to be higher, owing to the limitations of FDA's voluntary event reporting system.

Previous warnings on fluoroquinolones (still in effect) have included:

• Risk of tendon rupture and tendinitis (2008)

• Worsening myasthenia gravis (2011)

• Irreversible peripheral neuropathy (2013)

• Neuro-musculoskeletal side effects with potentially permanent disability (2016)

Available fluoroquinolones include levofloxacin, ciprofloxacin, moxifloxacin, ofloxacin, gemifloxacin, and delafloxacin, along with over 60 generic versions.

Fluroquinolones are broad spectrum, highly effective antibiotics with a vital role in the treatment of severe or dangerous infections, especially in patients with penicillin allergies. But the FDA directly advised against the widespread practice of prescribing fluoroquinolones for less-serious conditions:

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."

Source: FDA