• FDA changes warning label on popular antibiotics

    By: Alexa Ashwell

    Updated:

    CHARLOTTE, N.C. - Last year Channel 9 investigated patients concerned that popular antibiotics could have having devastating side effects.

    Patient Donna Versace spoke to Channel 9 after she learned she won her lawsuit against the Food and Drug Administration.

    Now the FDA is requiring label changes for a category of antibiotics known as fluoroquinolones that includes brand names like Ciprofloxacin.

    This is after an FDA safety review found the anti-bacterial drugs are associated with "disabling and potentially permanent, serious side effects."
     
    Rachel Brummert has been arguing that for years.
     
    “The FDA acknowledging this is really a big step," Brummert said.
     
    She heads a foundation headquartered in Charlotte that advocates for patients she said suffered permanent side effects from the drugs. 
     
    “Two of us from the foundation went up (to Washington, D.C.) to testify with 33 other victims who told their story to the panel,” she said. “They made the right decision.”
     
    The decision to warn patients of side effects associated with those drugs outweigh the benefits for patients with sinus infections, bronchitis and urinary tract infections, officials said.
     
    Other side can impact tendons, muscle joints, nerves and the central nervous system.
     
    Brummert said she's suffered permanent damage to her tendons after taking the medication 10 years ago.
    She believes the warnings should go even further.

    The FDA said in an email these drugs should be reserved for people who don't have alternative treatment options.

    Next Up: