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July 26, 2016: FDA Expands Boxed Warning to Address Painful Levaquin Reactions

Painful Levaquin Reactions

In order to address the disabling and potentially permanent side effects of quinolone medications such as Levaquin, The U.S. Food and Drug Administration (FDA) approved changes to the Boxed Warning, the FDA’s strongest warning. This warning serves to inform doctors and patients of the risk of damage to tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.
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Background

Fluoroquinolones, such as Levaquin, are antibiotic medicines that work by killing or stopping the growth of bacteria that can cause illness.

Adverse Event Reports of Painful Levaquin Reactions

Between November 1997 to May 2015, the FDA received 178 reports of apparently healthy patients who took an oral fluoroquinolone and, as a result, developed severe symptoms of “disabling and potentially irreversible” side effects.

Many patients described how seriously the disability impacted their lives, including job loss and the resulting lack of health insurance, large medical bills, financial problems, and family tension or dissolution
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FDA Painful Levaquin Reactions Report Summary:

  • “These adverse reactions to fluoroquinolones, such as Levaquin, occurred within hours to weeks after starting the fluoroquinolone.”
  • “At the time we received the reports the side effects had continued for an average of 14 months, to as long as 9 years, after stopping the medicines.”
  • “Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.”
  • “Long-term pain of any kind was the most commonly reported symptom, with 97% of all cases reporting pain associated with the musculoskeletal adverse reactions.”
  • “The ongoing neuropsychiatric adverse reactions were reported to be distressing, affecting employment and quality of life.”

Painful Levaquin Reactions:

levaquin side effects

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