Friday, July 29, 2016

FDA Bolsters Warnings about Class of Antibiotics

The U.S. Food and Drug Administration announced Tuesday that it’s strengthening label warning on a class of antibiotics called fluoroquinolones because the drugs can lead to disabling side effects, including long-term nerve damage and ruptured tendons.

The agency also cautioned that these bacteria-fighting drugs – including levofloxacin (Levaquin) and ciprofloxacin (Cipro) – shouldn’t be prescribed for sinusitis, chronic bronchitis or simple urinary tract infections unless no other treatment options exist.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” Dr. Edward Cox said in an FEDA news release. He’s director of the Office of Antimicrobial Products at the FDA’s Center for Drug Evaluation and Research.

“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,” Cox said.

A safety review revealed that potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system can occur hours or weeks after exposure to fluoroquinolone pills or injections. Also, two or more serious side effects can occur together, the FDA said.

Because of this, the FDA recommends reserving these antibiotics for serious bacterial infections, such as anthrax, plague and bacterial pneumonia.

In these cases, “the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option,” the agency said.

Besides Cipro and Levaquin, other fluoroquinolones include moxifoxacin (Avelox), ofloxacin (Floxin) and gemifloxacin (Factive).

The FDA has reported concerns about fluoroquinolones since 2008. At that time, it added a boxed warning because of increased risk of tendinitis and tendon rupture.

Almost three years later, the FDA warned that the drugs could worsen symptoms of the neuromuscular disease myasthenia gravis. The potential for serious nerve damage (irreversible peripheral neuropathy) was detailed in 2013.

Finally, last year an FDA advisory committee said uncomplicated sinus, urinary and bronchial infections should be treated with other options.

My Take:
Despite ongoing warning from the FDA, the number of prescriptions written for fluoroquinolones actually increased from 2011 to 2013, the most recent years that statistics are available. I suspect this latest warning will do little to stem the tide.

In 2013, 33.2 million scripts were written for fluoroquinolones. That’s a little more than one for every 10 people in the U.S. Unfortunately, until the attorneys step in and the lawsuits start to settle (watch for the TV ads), physicians will not alter their standard of practice.

Occasionally, I do see a patient with bacterial pneumonia that might benefit from this class of drugs. But how often do physicians in the U.S see anthrax or the plague? Doctors are routinely prescribing these drugs for UTIs and upper respiratory infections. The later are usually viral in nature and won’t response to any antibiotic therapy.

The Bottom Line:
Stay away from Cipro and all the drugs in this class. Voice your concerns and ask your physician for an alternative. If you believe you have suffered damage as a result of taking any of these drugs, seek qualified nutritional advice. There are many supplements that reduce inflammation and speed repair of tendons and others that are quite effective in treating neuropathy.

July 26, 2016 National Institutes of Health

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