The FDA Fails Again With Fluoroquinolone Psychiatric Labeling Changes
For the Food and Drug Administration it doesn’t matter how many people’s lives are utterly destroyed, just as long as some lives are saved and a disproportionate profit is earned.
Levaquin Label Update
June 28, 2019, the FDA updated the Levaquin label MEDICATION GUIDE which is the information given to patients.
FDA Levaquin Label Update
The separate “Psychiatric Adverse Events” section was FINALLY added to the Levaquin label and it includes the additional psychiatric adverse events.
Another Milestone Crossed: Fluoroquinolones, The FDA, and 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.
Some of Dr. Bennett’s Requested Warnings Added by FDA
Adverse events added by the FDA are some of those requested by Dr. Bennett previously.
FDA Updating Warnings for Flouroquinolones
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.
FDA Fails to Go The Distance, Yet Again
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.
FDA Shell Game? I Hope Not
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.
FDA Changes Fluoroquinolone Label But Denies Citizen Petition on 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
Becoming a Danger to One’s Self and/or Others by Taking a Fluoroquinolone
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.
Fluoroquinolone Community Goes to the FDA: Pediatrics and Rhabdomyolysis
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.
Yet Another FDA Failure: PatientsLikeMe®
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.
Fluoroquinolone Community Goes to the FDA: The Pressure Continues
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.
The Sad Truth of Pediatric Fluoroquinolone Usage
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.
Fluoroquinolone Community Goes to the FDA
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.