FDA enhances warnings on fluoroquinolones

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration has enhanced warnings of side effects of fluoroquinolones and limited their use to patients with no alternatives.

FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive).

The FDA added a box warning to the antibiotics in July 2008 to inform users about the increased risk of tendinitis. In August 2013, it required updates to the labels to describe the potential for irreversible peripheral neuropathy.

The box warning was updated on Tuesday to highlight the disabling and potentially permanent side effects of the drugs.

The FDA said in a statement, "While these drugs are effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system. These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent."

The complete statement is available online here: http://bit.ly/2a8Xvup.

(c) Copyright Thomson Reuters 2016. Click For Restrictions - http://about.reuters.com/fulllegal.asp