Tagged: FDA

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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. 

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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.

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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.

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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.

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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.

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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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Lessons From Ashley Madison

The Ashley Madison affair has led to extortion, divorces, ruined lives, lost jobs, and even suicides. But, let me let you in on another dirty little secret, one much worse than Ashley Madison…