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A “Black Box” Warning About Tendon Injury Is Added To The Levaquin Package Insert In July 2008

Antibiotics In The Fluoroquinolone Class, Such As Levaquin, Cipro, And Avelox, Now Carry This Stronger Warning About Increased Risk Of This Side Effect

After over six years of pressure, in July 2008 the FDA forced Ortho-McNeil, a subsidiary of Johnson & Johnson, to add a “black box” warning to their fluoroquinolone antibiotic Levaquin (levofloxacin) to strengthen existing warnings about the increased risk of developing severe tendonitis and tendon rupture.

Earlier in 2008 Public Citizen put pressure on the FDA to take this action. As the number of patients suffering from serious tendon injuries was growing, Public Citizen filed a lawsuit against the FDA intending to bring the importance of these serious fluoroquinolone antibiotic side effects to the FDA’s attention. Filed in the U.S. District Court for the District of Columbia, Public Citizen used their lawsuit to push for the “black box” warning to be added to the package insert of Levaquin and the other fluoroquinolone antibiotics. Ultimately, Public Citizen succeeded and the black box was added.

The call for this black box warning on the fluoroquinolone antibiotics was not new to the FDA. In 2006 Public Citizen petitioned to add this most serious warning to Levaquin, Cipro, Avelox, and other antibiotics in the fluoroquinolone class. As an example, although Levaquin’s warning label in 2006 did list tendon injury as a potential side effect, this apparent warning was buried in a long list of possible adverse reactions and, as such, made it appear that the risk of developing a tendon rupture or severe tendonitis was no more significant than any other Levaquin side effect.

However, from November of 1997 through March of 2007 the FDA received 336 reports of tendon rupture. That number was much to high for Public Citizen, and the FDA, to ignore. On July 8, 2008 a press release from the FDA stated that the black box warning would be added, not only to Levaquin, but to all fluoroquinolone antimicrobial drugs, including Avelox and Cipro among several others.  However, Levaquin stands out among the others with the distinction of having the most tendon injury lawsuits files, to date.

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