Category: FDA

3

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. 

FDA 0

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.

1

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.