Levaquin Black Box Warning

Levaquin Black Box warnings are intended to alert doctors and patients about the serious, irreversible, and life-threatening side effects associated with the use of the fluoroquinolone antibiotic Levaquin (generically, levofloxacin). Produced by Ortho-McNeil (a division of Johnson & Johnson), Levaquin was first approved by the Food and Drug Administration (FDA) on December 20, 1996, and the drug is primarily prescribed to treat various types of bacterial infections, including (not limited to):

  • Acute bacterial sinusitis
  • Anthrax inhalation
  • Chronic bacterial prostatitis (prostate gland infections)
  • Pneumonia
  • Skin infections
  • Urinary tract infections

Depending on the type and severity of the infection being treated, Levaquin may be prescribed for 3 to 60 days, and the medication can be ingested via pill, injection, oral solution, ear drops, or eye drops.

Serious Side Effects Trigger Levaquin Black Box Warning

Despite being effective at treating bacterial infections, Levaquin is also known to cause a range of severe side effects, including:

  • Acute pancreatitis
  • Hypoglycemia
  • Irregular heartbeat
  • Kidney damage
  • Permanent double-vision or loss of vision
  • Seizures
  • Severe allergic reaction
  • Severe damage to the central nervous system
  • Spontaneous tendon rupture
  • Stevens-Johnson syndrome (SJS) or toxic epidermal necrosis (TEN) – Both conditions cause the top layer of skin to separate from the bottom layers, along with severe inflammation of the mucous membranes (in the eyes, nose, mouth, genitals, etc. SJS is diagnosed when symptoms effect less than 10 percent of the body, and TENS is diagnosed when more than 30 percent of the body is plagued by symptoms. Between 10 and 30 percent, either SJS or TENS may be diagnosed.
  • Tendonitis

While children and the elderly have the highest risk of developing serious Levaquin side effects, all Levaquin patients are at risk. Side effects have been reported to develop long after cessation of this medication.

The grave nature of these side effects spurred the FDA to require that Ortho McNeil include a Levaquin Black Box warning in July 2008. Although the Levaquin Black Box warning was rolled out in September 2008, it has been reported that old packaging without the Levaquin Black Box label was available as late as July 2009.

If you or a loved one have used Levaquin and suffered from any side effect including pancreatitis, hypoglycemia, seizures, SJS, or TEN, you should contact our Levaquin attorneys immediately for a free and confidential case review. You may be entitled to compensation and we can help.