2008 FDA Warnings on Levaquin First Requested by Consumer Group in 1996
By Jim Greene
Published on December 22, 2009
In 1996, 2005 and 2006, a national advocacy group and the state of Illinois asked the federal government to order a package warning that taking fluoroquinolone antibiotics, including Johnson & Johnson's Levaquin®, could result in damage to tendons. Today, the drug giant is facing lawsuits by alleged victims of tendon damage.
Fluoroquinolones are prescription antimicrobials used to fight bacterial infections, particularly those of the respiratory system and urinary tract. The most serious tendon damage reported is to the Achilles tendon of the heel, sometimes requiring surgery.
Advocacy Group Requested Warnings in 1996
In August 1996, Public Citizen, an advocacy group based in Washington, D.C., petitioned the U.S. Food and Drug Administration (FDA) for package warnings about the possibility of tendinitis and tendon ruptures as a side effect of taking fluoroquinolones.
Two physicians serving as medical directors for the Illinois Attorney General's Office wrote to the U.S. Food and Drug Administration (FDA) in May 2005, requesting stronger warnings to be placed more prominently on packages, along with letters to doctors and other medical professionals from manufacturers, and a review by the agency's Drug Safety Oversight Board.
Public Citizen again contacted the FDA in August 2006, noting that their previous request had resulted in only a mild warning, included in a long list of much less likely side effects. They not only requested more prominence for the tendon warning, but also a separate sheet of detailed usage instructions and side effect warnings.
Stronger FDA Action Came in 2008
The warnings requested were fully implemented by the FDA in July 2008. The action included a reminder that fluoroquinolones are indicated only for bacterial infections and should not be used to treat viral infections. Medical professionals are also advised to warn patients that tendon damage side effects are more likely in those over 60 years of age, those who are taking corticosteroids, and those who have had a kidney, heart, or lung transplant.
Court proceedings against Johnson & Johnson in the matter are expected to begin in August 2010.
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