FDA Updates Label for Fluoroquinolone Antibiotics

Despite the amazing advancements of modern medicine, not every drug that is created or discovered is entirely safe. The U.S. Food and Drug Administration has measures in place to ensure drugs that make it to the market are effective and relatively safe – any known risks are worth it in regard to the potential outcomes for patients. But the FDA is also there to add labels and publish safety warnings when it learns new information about drugs. In fact, the FDA published an updated warning about the potential effects of a class of antibiotics known as fluoroquinolones. If you have been injured by the use of fluoroquinolone antibiotics and you were not warned about the risks, contact the experienced Tavares defective drug attorneys of Oldham & Smith right away to learn about your rights.

Previous Label Changes

Fluoroquinolones include the antibiotics levofloxacin, ciprofloxacin, moxifloxacin, ofloxacin, and gemifloxacin. The FDA has previously updated this class of antibiotics’ label, adding boxed warnings regarding the possible debilitating side effects of the antibiotics. A boxed warning is the strongest warning the FDA uses on drugs. It was first added in 2008 for the risk of tendon rupture and tendinitis. In 2011, the FDA included the risk of worsening symptoms of myasthenia gravis, a neuromuscular disease. In 2013, the FDA added warnings about irreversible peripheral neuropathy, which is the medical terminology for nerve damage. This newest warning includes an update to the boxed warning about the potentially disabling and irreversible side effects.

Limited Use Now Advised

Fluoroquinolones kills or stops the spread of certain bacteria. According to the FDA, these antibiotics are effective for serious bacterial infections but the potential side effects outweigh the benefit of using them for more common infections like sinus infections, chronic bronchitis, and urinary tract infections. Instead of being used for infections that are known to be treated with other antibiotics, fluoroquinolones should be used for infections that do not have other options for treatment – and the new label says so.

Did Your Doctor Warn You About the Risks?

If you were injured after taking a fluoroquinolone antibiotic, an action against your healthcare provider may hinge on whether you were aware of the risks associated with the drug or not. Physicians are required to discuss possible side effects of potential treatments with you. If they do not, you are not able to knowingly consent to taking a drug or undergoing a certain procedure. Suffering a risk you were unaware was possible may grant you a cause of action under the law. However, these cases are often complicated. You should speak with an attorney as soon as possible.

Contact an Attorney Today

The attorneys of Oldham & Smith have years of experiencing in medical malpractice and dangerous drug cases. Give us a call today,(352) 292-1620, or use our online contact form to schedule a consultation. We will answer your questions and determine if you should move forward with an investigation or lawsuit.


Contact Us Today to Learn More

  • Please enter your first name.
  • Please enter your last name.
  • Please enter your phone number.
    This isn't a valid phone number.
  • Please enter your email address.
    This isn't a valid email address.
  • Please make a selection.
  • Please enter a message.