Failing Fluoroquinolones – FDA Requires Manufacturers of Potentially Dangerous Antibiotics To Update Drug Labels

First, the U.S. Food and Drug Administration (FDA) issued a safety communication warning consumers about the dangerous side effects of a type of antibiotic known as fluoroquinolones. Aneurysms. Arrhythmia. Inflammation and pain to the joints, muscles and tendons. Permanent damage to the central-nervous system. Type 2 diabetes. All from the little pills intended to clear up infections.

Now, the FDA has required the manufacturers of the drugs sold on the market as Avelox, Cipro, Factive, Floxin and Levaquin to be labeled accordingly, alerting those taking them as to the potential risks. Further, the agency is telling physicians who prescribe them to do so only when there is no other alternative for their patients.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” Dr. Edward Cox, of the Center for Drug Evaluation and Research, said in a press release titled “FDA updates warnings for fluoroquinolone antibiotics.” “It’s 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.”

Doctors are quick to put pen to pad for the medication in cases of bronchitis, sinusitis and urinary-tract infections (UTIs). Not so fast, the agency said. A review by the Antimicrobial Drugs Advisory Committee, formerly the Anti-Infective Drugs Advisory Committee, revealed the dangerous side effects can occur within hours, days or weeks of taking oral – and injectable – fluoroquinolones.

The American Academy of Family Physicians did some research on the topic, too.

“A search of the FDA Adverse Event Reporting System database from November 1997 to May 2015 identified 178 cases in which apparently healthy patients who took an oral fluoroquinolone to treat ABS (acute bacterial sinusitis), ABECB (acute bacterial exacerbation of chronic bronchitis) or uncomplicated UTI developed disabling and potentially irreversible adverse reactions,” the academy said in an article on its Web site titled “Use Fluoroquinolones Only as Drug of Last Resort for Some Infections.”

In reaction to the news, JAMA is offering alternatives to the antibiotics in question. Its recommendations include generic amoxicillin or doxycycline for ABS and Bactim, Macrobid or Monurol for UTIs.

Anyone taking fluoroquinolones who experiences an adverse event is urged to share the incident with the FDA through the MedWatch Online Voluntary Reporting Form. Meanwhile, thousands of lawsuits continue to mount against them, specifically with regard to Johnson & Johnson’s Levaquin.