As reported. The FDA has announced that it will update the FQ labels as follows: “The mental health side effects to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.”
In September 2014, Dr. Charles Bennett submitted a Citizen Petition to the FDA asking for more psychiatric adverse events to be placed on the Levaquin label, as indicated in the below excerpt from this Citizen Petition. Below, the highlighted blue adverse events have been on the Levaquin labels in the past; the highlighted red ones are the ones requested by Dr. Bennett which the FDA has now agreed to add. Those not highlighted have not yet been addressed by the FDA. As you can see, according to the FDA’s announcement, six of Dr. Bennett’s requested additional warnings will be added.
This is great news for the FQ community.
Excerpt from the September 2014 Citizen Petition submitted to the FDA by Dr. Bennett, asking for more Levaquin-associated psychiatric adverse event warnings.
Require a “Psychiatric Effects” heading under “Warnings and Precautions”
It is requested that a specific “Psychiatric Effects” heading be added under the “Warnings and Precautions” section of the Levaquin label rather than listing Levaquin Psychiatric Adverse Events under the “Central Nervous System Effects” heading, as is currently done. It is requested that the following “Psychiatric Effects” section be added to the Levaquin label.
Serious psychiatric events including, toxic psychoses, restlessness, anxiety, confusion, hallucinations, paranoia, depression, nightmares, insomnia, suicidal thoughts or acts, feeling abnormal, loss of consciousness, disorientation, agitation, delirium, depressed level of consciousness, amnesia, coma, disturbance in attention, panic attack, memory impairment, and nervousness have been reported in patients receiving fluoroquinolones, including Levaquin. These events may start during treatment or may be delayed and start days, weeks, or months after the last dose.
Please stay tuned to MyQuinStory for updated reports on this and other FQ’s related news.