FDA Issues New Safety Alert for Popular Antibiotics

Yesterday, regulators at the U.S. Food and Drug Administration (FDA) issued a new safety alert, urging medical professionals to limit their use of certain popular antibiotics – fluoroquinolone antibacterial drugs – for some patients.

According to this warning, regulators have discovered a link between the use of fluoroquinolones and the development of “disabling and potentially permanent serious side effects” that can impact “the tendons, muscles, joints, nerves and central nervous system.”

Patients who reportedly have been associated with the highest risk of these serious drug complicationsinclude (but are not limited to) those with:

  • Acute sinusitis
  • Acute bronchitis
  • Urinary tract infections.

For these patients, the FDA has warned that the potential risks of using of fluoroquinolones far outweigh the benefits these drugs could provide. Consequently, regulators are strongly advising that medical professionals only consider prescribing or administering fluoroquinolones for these high-risk patients when there are no alternative treatment options available (i.e., all other alternatives have been exhausted).

FDA-Approved Fluoroquinolones: Drug Brand Names associated with the FDA Warning

The following provides a list of the brand name medications (with their active ingredient following in parentheses) of the fluoroquinolone drugs included in the FDA’s warning:

  • Avelox and Moxifloxacin Injection (Moxifloxacin)
  • Cipro (Ciprofloxacin)
  • Cipro extended-release (Ciprofloxacin extended-release)
  • Factive (Gemifloxacin)
  • Levaquin (Levofloxacin)
  • Ofloxacin (Ofloxacin)

Please note that generic versions of the above-listed drug may be available and that those are also intended to be included in this FDA warning.

What Now?

In addition to urging medical professionals to carefully restrict their use of fluoroquinolones, the FDA is also now informing:

  • Doctors to immediately terminate the use of fluoroquinolones in any patient who starts to develop signs of serious complications – Some warning signs of these severe side effects can include (and are by no means limited to):
    • Tendon, muscle and/or joint pain
    • Nerve-related complications, such as tingling or pricking sensations
    • Cognitive dysfunction, including confusion and/or hallucinations.
  • The general public to immediately contact their health care professionals if they start experience any of the above-mentioned signs of serious fluoroquinolone side effects.

Officials have also noted that their investigation of fluoroquinolones (and their related side effects) is ongoing and that additional updates will be reported as soon as they become available.

Contact a Columbia SC Personal Injury Attorney at Chappell Smith & Arden, P.A. Attorneys at Law

If you have been harmed by a potentially dangerous drug – or by any dangerous or faulty product, contact a Columbia SC personal injury attorney at Chappell Smith & Arden, P.A. for clear answers about your rights and options for proceeding, as well as effective legal advocacy moving forward.

You can call our firm at 866-881-8623 or email us via the contact form on this page to set up a free, no obligations initial consult with one of our lawyers. During this meeting, you can find out more about your rights, as well as how we can help you.

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