I have found, more often than not, that the FQ data trail leads us into areas where we do not want to go; areas that we would normally avoid, if it were up to us. Areas that are ugly inconvenient truths.
Cipro 28,000 Deaths and Counting...
Levaquin 26,000 Deaths and Counting...
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.
The separate “Psychiatric Adverse Events” section was FINALLY added to the Levaquin label and it includes the additional psychiatric adverse events.
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.
The FDA is strengthening the current warnings in the prescribing information that the fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
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..
This is a good high profile opportunity for us to continue to warn the general public, family and friends about the dangers posed by the Fluoroquinolones.
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!
I am ecstatic about the new label changes. But given the FDA’s past track record, I will not happy until every medical professional, who has the ability to prescribe a FQ, is familiar with the label changes and safety precautions.
I think it was no coincidence that the FDA denied the mitochondrial citizen petition during the same time frame that they approved label changes. Right now the FDA is not acknowledging even the risk of mitochondrial toxicity.
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