Levaquin Label Update
June 28, 2019, the FDA updated the Levaquin label MEDICATION GUIDE which is the information given to patients.
Tagged: FDA
Dr. Bennet and SONAR Submits New Citizen Petition Regarding FQAD
Dr. Bennett and Southern Network For Adverse Reactions (SONAR) have submitted another Citizen Petition to the FDA requesting new Fluoroquinolone Black Box Warning.
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.
Pulling The Trigger: How the Fluoroquinolones Can Cause Mutations and Disease
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..
Hillary Clinton and Levaquin, A Teachable Moment
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.
Fluoroquinolone Use In The Emergency Room: Go To The ER And Get “Floxed”
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!
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.
The Voices Heard Round The World – The November 5th FDA Meeting
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.
FDA To Hold Upcoming Meeting on Fluoroquinolones
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.
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