Some Antibiotics Now Labeled with Stronger Warnings Following FDA Decision

The U.S. Food and Drug Administration recently required a new warning for peripheral neuropathy and tendon injuries on a group of antibiotics called fluoroquinolones. Drugs in this class include:  Levaquin (levofloxacin); Cipro (ciprofloxacin); Avelos (moxifloxacin); and Floxin (ofloxacin) Factive (gemifloxacin).

The new warnings are “black box” warnings on the drug labels, the FDA’s strongest type of warning.  The new warnings concern debilitating side effects including tendinitis, tendon rupture, nerve damage and central nervous system effects, and exacerbation of Myasthenia Gravis.

Fluoroquinolones were previously widely prescribed for common infections such as urinary tract infections, upper respiratory infections, sinusitis, and bronchitis.  Now the FDA says, however, that they should be used only for serious bacterial infections such as Anthrax and Plague.

In an FDA news release, Dr. Edward Cox said, “Fluoroquinolones have risks and benefits that should be considered very carefully. It’s more important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”

New publicly released information has shown that some permanent side effects could occur within hours or weeks of using the medication orally or intravenously. Permanent side effects can damage joints, nerves, the central nervous system, muscles, and tendons.

Concerns surrounding fluoroquinolones have existed since 2008 as reports of adverse side effects increased.  In 2013, a determination that potential for serious nerve damage, such as irreversible peripheral neuropathy, resulting in additional warnings to be issued regarding use of these drugs.

Contact the dedicated attorneys at Harman Law, LLC with any questions regarding your use of fluoroquinolone antibiotics and severe side effects. Our staff is compassionate. We offer a free, no cost, and no obligation initial consultation for every client. Contact us directly at 1-888-55-HARMAN or 404-554-0777. You can also reach us via live chat on our website or via our web contact form to discuss your potential claim.