June 28, 2019, the FDA updated the Levaquin label MEDICATION GUIDE which is the information given to patients.
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.
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
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 August 24th, 2015, members from the FQ community met with staff from the FDA in a third meeting to address the various FDA failures to adequately warn the general public about the true dangers FQ's pose to the general public, especially our children.
Why would the FDA make such an outrageous decision to enter into an unprecedented agreement to monitor post-marketing drug surveillance with a private company run by ex-pharmaceutical executives? The FDA would be better off looking at its FAERS data. If they did, they would see drug signals that they have ignored, especially for FQ's.
On June 10th, 2015 representatives from the Fluoroquinolone community met with Senate Staffers at the Dirksen Senate Building in Washington, D.C. to ensure pressure is maintained on the FDA in regards to updated warnings.
Sadly, the FDA review states that children experience the same Levaquin Adverse Events as adults. This means that the children have the possibility of experiencing adverse events that are consistent with mitochondrial toxicity.
We believe that our meeting, in addition to the extensive media attention, offers the best hope for action by the FDA on Fluoroquinolones to date.