• FOX13 Investigates: Powerful drug that can have damaging effects

    By: Jim Spiewak


    Fluoroquinolones are known as a powerful family of antibiotics. They're pills that can be prescribed to anyone and they are, according to many doctors, effective for treating serious bacterial infections.

    However, some experts say they are drastically over prescribed and carry potential side effects that some say may ruin lives. Doctors don’t know the damaging effects they may have.

    The two most common fluoroquinolones are Cipro and Levaquin. For the first time ever, the Federal Drug Administration might recognize the listed side effects potentially brought on by these antibiotics, as a new medical disability.

    Aaron Boggs was not diagnosed, but his symptoms are all listed side effects of Levaquin, which he took for one week back in 2014 to treat a urinary tract infection.  Today, Boggs told FOX13 he experiences insomnia, joint pain and has a hard time doing everyday activities.

    “Here I am 18 months later, almost daily or weekly there's some new effect manifesting,” Boggs said. “I don't know if it will ever stop.”

    Fluoroquinolones were designed to treat serious infections like pneumonia and anthrax. Some experts say they're so strong they wipe out good and bad bacteria.

    Dr. Michael Gelfand is an infectious disease professor at the University of Tennessee.  When discussing the antibiotics, he said, “clearly a fluoroquinolone is a shotgun weapon.”

    In 2013, an independent review by the FDA found a connection between permanent neurological disabilities in some patients after quinolone use. The Feds requested the makers add additional warnings to the black box warning already in place.

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    Dr. Gelfand said many prescribing doctors aren't aware of any of this.

    “Every physician probably doesn't spend a lot of time looking at the boxes and the prescribing information,” Gelfand told FOX13.

    The FDA has tracked quinolone side effects in more than 1,100 cases.  A new report, set to be released Thursday, will classify many of those patients with fluoroquinolone-associated disability (FQAD).

    It's unclear if the acknowledgment will develop into any relief for patients already suffering, but Dr. Gelfand said the discussion will help break a dangerous trend.

    “There's a temptation to give a powerful drug at a low cost to the patient,” Dr. Gelfand told FOX13. “Forgetting the side effects can be important.”

    The FDA is meeting tomorrow in Baltimore with representatives from Bayer and Johnson and Johnson, along with hundreds impacted by fluoroquinolones. 

    FOX13 reached out to Johnson & Johnson, and they sent us the following statement:

    “Our first priority is the well-being of the people who use our medicines. LEVAQUIN® (levofloxacin) has been used for nearly 20 years to treat bacterial infections, including those that may be serious or life-threatening. LEVAQUIN® is part of the important fluoroquinolone class of anti-infective prescription medications, and its safety and efficacy profiles are well known and established.

    We look forward to participating in the Advisory Committee meeting and continuing to work with the FDA to support the safe and appropriate use of fluoroquinolone antibiotics.”

    Bayer was also asked for comment, and they sent this statement:

    “Bayer looks forward to an open medical discussion with the FDA’s Antimicrobial Drugs and Drug Safety and Risk Management Advisory Committees regarding the benefits and risks of fluoroquinolones for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections. Fluoroquinolones are an important class of antibiotics that are indicated to safely and effectively treat multiple types of infections.

    Two Bayer drugs will be discussed during the meeting: Cipro® (ciprofloxacin) and Avelox® (moxifloxacin). Cipro and Avelox were first approved by the FDA in 1987 and 1999, respectively. Hundreds of millions of patients have relied on Cipro and Avelox to treat a range of infections for many years, both in the U.S. and around the world. Since 2004, Cipro has been distributed as ciprofloxacin by several generic pharmaceutical manufacturers. In the U.S., Avelox is currently marketed by Merck, Inc.

    Bayer’s highest priority is patient safety, and over the years we have worked hard to ensure healthcare providers and their patients understand the benefits and risks associated with fluoroquinolone use.  We are committed to working with the FDA as it considers the Committees’ advice.”

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