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FDA Issues New, Enhanced Warnings for Levaquin & Other Fluoroquinolone Antibiotics

FDA Issues New, Enhanced Warnings for Levaquin & Other Fluoroquinolone Antibiotics

FDA Issues New, Enhanced Warnings for Levaquin & Other Fluoroquinolone Antibiotics

Days ago, regulators at the U.S. Food and Drug Administration (FDA) issued a new warning for Levaquin and other fluoroquinolone antibiotics, alerting the public that these drugs have been linked to “disabling and potentially permanent side effects.”

As part of this alert, regulators also announced that they have approved stricter warning labels for fluoroquinolone antibiotics and that they are now urging physicians to carefully limit their administration of these drugs – particularly for patients “with less serious bacterial infections.”

Brief Background on Fluoroquinolone Antibiotics & Their Risks

Fluoroquinolone antibiotics are a class of drugs generally used to treat serious bacterial infections.

In addition to Levaquin (levofloxacin), other FDA-approved drugs in this class include (but may not be limited to):

  • Cipro (ciprofloxacin)
  • Avelox (moxifloxacin),
  • Factive (ofloxacin and gemifloxacin).

To date, research and patient reports have indicated that fluoroquinolone antibiotics have the potential to cause debilitating and possibly irreversible side effects, including (but not necessarily limited to) significant, permanent damage to the central nervous system, tendons, joints and/or muscles.

These risks have been the focus on regulators for years. The following presents a timeline of previous FDA actions associated with this group of risky drugs:

  • May 2016 – The FDA issues a warning that fluoroquinolone antibiotics should only be used to treat acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections when no other treatment options are available.
  • November 2015 – An FDA committee concludes that, for uncomplicated bacterial infections, the risks of using fluoroquinolone antibiotics typically outweigh any benefits.
  • August 2013 – The FDA orders updated warning labels for all fluoroquinolone antibiotics in order to warn the public about the risk of serious never damage associated with these drugs.
  • February 2011 – The FDA orders that the risks of “myasthenia gravis” be added to the warning labels for fluoroquinolone antibiotics.
  • July 2008 – The FDA approves the addition of a boxed warning on fluoroquinolone antibiotics in order to highlight the risks of tendon damage associated with these drugs.

A Closer Look at the New Warning for Fluoroquinolone Antibiotics

As part of the latest FDA warnings for fluoroquinolone antibiotics, the makers of these drugs are now required to update the warning labels and patient medication guides for these drugs so they include information regarding:

  • The adverse side effects that can occur together (i.e., concurrently)
  • When the drugs should NOT be administered (e.g., for certain conditions and when other treatment options may be available)
  • The specific safety issues associated with these drugs.

Commenting on this FDA action, Dr. Edward Cox, a director in the FDA’s Center for Drug Evaluation and Research, has stated:

Fluoroquinolones have risks and benefits that should be considered very carefully… 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.

Contact a Kingston Personal Injury Lawyer at Charles N. Rock, P.L.L.C.

If you or a loved one has been hurt by any risky or dangerous drug, you can turn to Kingston Personal Injury Lawyer Charles N. Rock for aggressive legal advocacy and effective help obtaining the compensation to which you may be entitled.

For nearly 20 years, Charles N. Rock has been dedicated to holding individuals and corporations alike accountable for injuring his clients, and he will work tirelessly to help injured people secure the compensation and justice they deserve.

To find out more about your best options for moving forward, contact us today to schedule a free, no obligations initial consultation. You can set up this meeting by calling (845) 3831170 or by emailing us using the contact form on this page. To ensure that you have the legal support you need as soon as possible, Attorney Charles N. Rock can meet you at your home or a hospital when needed.