Levaquin — The New Reality, A Black Box Warning

The FDA has now issued a Black Box Warning to healthcare professionals setting forth the “increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.”

Such warning comes years after advocacy by Public Citizen, including a compilation of thousands of adverse event reports documenting patients whom had suffered tendinitis and tendon rupture related side effects from fluoroquinolones, including Levaquin.

Such efforts by Public Citizen, originate back to August 2006, whereby a formal Petition was filed seeking FDA action regarding a Black Box Warning.

Despite years of FDA inaction, the recommendation in favor of a Black Box Warning has now formally manifest itself in the form of a label change with the FDA’s most recent notification to health care professionals.