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The FDA has issued several Levaquin warnings in an attempt to alert consumers and health care providers of the dangers associated with the medication. Over the past decade, Levaquin has generated substantial controversy due to findings that it may cause a number of severe, life-threatening side effects, including:

• Damage to the liver, kidneys and/or pancreas
• Double vision
• Fatal hypoglycemia (low blood sugar)
• Heart problems, including arrhythmia and/or cardiotoxicity
• Muscle deterioration and neuromuscular diseases
• Nerve damage in the hands and/or feet
• Permanent loss of vision and/or loss of color vision
• Severe allergic reaction
• Severe anemia
• Severe central nervous system (CSN) disorders
• Stevens-Johnson syndrome (SJS) and toxic epidermal necrosis (TEN), life-threatening skin conditions
• Tendon injuries, including spontaneous tendon rupture and tendonitis

Levaquin is generically known as levofloxacin and is made by PriCara, a subsidiary of Ortho-McNeil-Janssen.

Is Levaquin FDA Approved?

The U.S. Food and Drug Administration (FDA) approved Levaquin for the treatment of serious bacterial infections in December 1996. Since this approval, however, the FDA has issued eight nationwide Levaquin warnings to alert the public about the types and severity of Levaquin side effects. In the most recent FDA warning, issued in October 2008, the FDA sent a letter to PriCara, mandating that black box warnings be printed on all Levaquin packaging and medication guides.

Levaquin Black Box Warning Alerts

Black box warnings are the most serious level of FDA warnings, as they highlight a medication's potential to cause serious, potentially fatal side effects. Full-fledged drug recalls are the only FDA action stronger than issuing a black box warning. Although FDA orders are legally binding, as much as eight months later in July 2009, the public was filing reports that some Levaquin packaging and medication guides lacked black box warnings.

Levaquin FDA Recall

To date, the FDA has not issued a Levaquin recall. Whether this will occur will depend on whether:

• More serious Levaquin side effects are discovered
• More patients report the development of severe Levaquin injuries

If you or a loved one has been harmed by Levaquin or another medication, contact our Levaquin lawyers to learn more about your legal rights.

"Fluoroquinolone Antibiotics Causing Tendon Ruptures"

A class of antibiotics known as fluoroquinolones needs heightened warnings about the risk of tendon rupture and tendonitis, said the U.S. Food and Drug Administration on Tuesday.

Fluoroquinolone antibiotics include:

...

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