FDA sent Petition re: Levaquin Use Causing Polio-Like Illness in Children

Fluoroquinolone antibiotics were originally manufactured to treat serious, life-threatening infections. They have increasingly been prescribed for minor infections and in some cases, when no infection is present at all.

A non-profit consumer group has submitted a Citizen’s Petition to the U.S. Food and Drug Administration (FDA) urging them to place stronger warnings on labels of all fluoroquinolone antibiotics. The most popular drugs in this class are Levaquin, Cipro and Avelox.

A New Jersey Quinolone Vigilance Foundation (QVF) has asked the FDA to investigate whether Levaquin could be related to the onset of paralysis or polio-like symptoms in some California children recently.

Despite Levaquin labels warning, “Levaquin is indicated in pediatric patients (6 months of age or older) only for the prevention of inhalation anthrax (post-exposure) and for plague,” Levaquin clinical trials were performed on children with other medical conditions, such as pneumonia and acute otitis media (ear infection).

“QVF is concerned that physicians are using Levaquin to treat children off-label in ways not approved by the FDA,” states QVF’s Executive Director Rachel Brummert. “We are also concerned that physicians and parents are depending on clinical trials that are closely associated with Johnson & Johnson, the study sponsor of the clinical trials and the maker of Levaquin. We want the FDA to seriously consider the impact of using Levaquin, an extremely potent antibiotic with known serious adverse events, on children.”

On June 18, 2014, Dr. Charles Bennett of the University of South Carolina submitted a Citizen Petition to the FDA Commissioner, asking for a Black Box warning to be added to the Levaquin label, advising doctors and patients of possible Mitrochondrial Toxicity. This has been implicated in diseases such as Parkinson’s, Alzheimer’s, and ALS.

If a medication does not have approval for use in children, why is it being prescribed? The lives of so many adults have been permanently injured as a result of these fluoroquinolone antibiotics. Why are they available for minor infections, especially in children? Feel free to comment on this blog post.

If you or a loved one suffered adverse side effects following the use of a fluoroquinolone (floxie) medication, you may be entitled to compensation for your damages. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878) for more information.

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