June 28, 2019, the FDA updated the Levaquin label MEDICATION GUIDE which is the information given to patients.
Dr. Bennett and Southern Network For Adverse Reactions (SONAR) have submitted another Citizen Petition to the FDA requesting new Fluoroquinolone Black Box Warning.
In an astonishing statement from the FDA, they acknowledged that since “Psychiatric Effects” will specifically be identified within the “Central Nervous System Effects” subheading, psychiatric adverse events are automatically assumed to be part of the existing Black Box warning.
Adverse events added by the FDA are some of those requested by Dr. Bennett previously.
Drug’s that can mutate DNA and create a disease process are downright scary. They start the ball rolling on a pathology that often appears later on..
One hundred patients who went to the Emergency Room and received a Fluoroquinolone were studied, in ninety nine of those cases, errors were made with the Fluoroquinolone!
On Thursday May 12, 2016 the FDA contacted those who have been pursuing label changes for the Fluoroquinolones and issued a public statement that the FDA is requiring label changes for antibacterial drugs called fluoroquinolones
It is very disturbing that an antibiotic, which is often given out for routine infections, may result in violence, anger toward others, and horribly, may result in suicide-related adverse events.
On Nov. 5th, the true stars of our community took to the podium at the FDA to tell their personal stories. I, along with countless others, were humbled and honored. This meeting represented a huge step in the progress we are making to gain complete recognition of the travesty that the fluoroquinolone class of pharmaceuticals has wrought upon society, to achieve justice for those that have been damaged by these drugs, and to prevent future unnecessary pain and suffering not only for this generation, but for generations to come.
We believe that the attention given the Fluoroquinolones through the combined media stories, past rallies, citizen petitions, in addition to community members meeting directly with FDA officials, provided some of the impetus, in part, for the scrutiny of the Fluoroquinolones being prescribed for these common health conditions.