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Putting Pressure On The FDA: Public Citizen Petition To Add Stronger Warnings To Levaquin Label

After More Than Ten Years On The Market, Public Citizen Asks The FDA To Take Another Close Look At Levaquin

After its initial 1996 approval by the FDA approval, in 2002 and again in 2007 Levaquin’s package insert, or warning label, was amended to include a warning about the risk of tendinitis and tendon rupture. This amended label stated that the risk of tendon injury is higher in those using corticosteroids at the same time as Levaquin. The warning about increased risk of tendon injury applied especially to the elderly.

Public Citizen, however, was unsatisfied. This consumer advocacy group felt that the risk of tendon injury was much too significant to be buried in a long list of potential side effects. There were numerous reports of this type of serious injury, and Public Citizen wanted to call attention to this important fact.

The August 2006 Public Citizen Petition concerning Levaquin and other antibiotics in the fluoroquinolone class urged the FDA to require the drug companies to add a “black box” warning about the risks for tendon rupture or severe tendinitis. Public Citizen also asked that so-called “Dear Doctor” letters be sent regarding the stronger warning and that pharmacists be required to issue patient medication guides showing the stronger warning. As mentioned above, this Petition was not limited to Levaquin; it included the other fluoroquinolone antibiotics -- such as Cipro, Tequin, and Avelox -- all of which have been associated with an increased risk of serious injury involving tendons in the leg, shoulder, and hand.

Finally in 2008, almost two years later, the FDA agreed that a stronger warning was necessary. In July of 2008 the Levaquin prescription insert, or label, was changed again to include a black box warning which emphasizes the increased risk for tendinitis and tendon rupture in all ages, but especially for those over 60 and who are also taking corticosteroids.

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