FDA Warns Widely Used Antibiotic Can Cause Serious Side Effects

The FDA has issued a drug safety warning on a class of antibiotics known as fluoroquinolone, including widely used Levaquin, Cipro, and Avelox, because of the risk of potentially disabling and permanent side effects including tendon ruptures, permanent nerve damage, vision problems, and suicidal thoughts, among other side effects.

Fluoroquinolone antibiotics can be taken orally or administered by injection, and are prescribed to treat or prevent serious bacterial infections, and include the following drugs:

  • Avelox (moxifloxacin)
  • Cipro (ciprofloxacin)
  • Cipro extended-release (ciprofloxacin extended-release)
  • Factive (gemifloxacin)
  • Levaquin (levofloxacin)
  • Ofloxacin (generic) (ofloxacin)

The FDA has ordered changes to the safety labeling and the “Warnings and Precautions” part of the label on this class of antibiotics to reflect its strongest safety warning and recommends patients read the Medication Guide to review the risks vs. benefits of taking the medication.

The FDA is also warning healthcare providers these drugs should not be prescribed to treat acute bacterial sinusitis, acute bacterial exacerbation or chronic bronchitis, and uncomplicated urinary tract infections because the potential serious complications and side effects outweigh the benefits. The FDA recommends they only be used to treat life-threatening conditions such as anthrax, plague, and bacterial pneumonia, and other bacterial infections for which there is no other treatment option available for certain patients.

Potential side effects when using fluoroquinolone antibacterial drugs include:

Tendon, Muscle, Joint & Nerve Problems:

  • Tendinitis
  • Tendon tears
  • Unusual joint or tendon pain or swelling
  • Muscle weakness
  • “Pins and needles” tingling or pricking sensation
  • Numbness in extremities

Central Nervous System:

  • Hallucinations
  • Anxiety
  • Depression
  • Suicidal thoughts
  • Confusion

Other Possible Side Effects:

  • Abnormal, rapid or strong heartbeat
  • Ringing or buzzing in the ears
  • Vision problems
  • Headache
  • Fatigue
  • Skin rash
  • Sunburn/Skin sensitivity to sunlight
  • Severe diarrhea
  • Trouble falling asleep
  • Patients may suffer two or more side effects simultaneously.

The FDA recommends you stop using the fluoroquinolone antibiotic you are taking if you notice any of these side effects, and notify your healthcare provider immediately. Side effects can appear within days or weeks of taking the antibiotic. Reports document some patients notice their side effects disappear once the medication is stopped, whereas other patients report suffering side effects ranging from 14 months to 9 years.

If you or a loved one has experienced any side effects or adverse reactions while taking a fluoroquinolone antibiotic, the FDA asks that you file an Adverse Event Report documenting your reaction to the drug. Adverse Event Reports can be completed online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home or by calling 1-800-332-1088.

And if you or a loved one has suffered permanent injury from a fluoroquinolone antibiotic, or any drug, contact an experienced pharmaceutical lawyer to answer your questions. For more information about fluoroquinolone antibiotics, please contact the attorneys at Bubalo Law PLC.