October 18, 2018: The separate “Psychiatric Adverse Events” section was FINALLY added and it includes the additional psychiatric adverse events listed in this section.
This is a huge accomplishment, based on the second Citizen Petition submitted by Dr. Bennett. 
Remember, the FDA said that since the “Psychiatric Adverse Reactions” section is under the “Central Nervous System Effects,” “Psychiatric Adverse Events” is BY DEFINTION, in the Black Box Warning!
5.4 Central Nervous System Effects
Psychiatric Adverse Reactions
Fluoroquinolones, including LEVAQUIN®, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychoses, hallucinations, or paranoia; depression, or suicidal thoughts; anxiety, agitation, restlessness, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. Attempted or completed suicide have been reported, especially in patients with a medical history of depression, or an underlying risk factor for depression. These reactions may occur following the first dose. If these reactions occur in patients receiving LEVAQUIN®, discontinue LEVAQUIN® and institute appropriate measures.
Central Nervous System Adverse Reactions
Fluoroquinolones, including LEVAQUIN®, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri), tremors, and lightheadedness. As with other fluoroquinolones, LEVAQUIN® should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction). If these reactions occur in patients receiving LEVAQUIN®, discontinue LEVAQUIN® and institute appropriate measures [see Adverse Reactions (6), Drug Interactions (7.4, 7.5), and Patient Counseling Information (17)].
The updated label information can be read here: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s070lbl.pdf on page 12.
I have struggled with depression since I was floxed 10 yrs ago. I had many adverse psychiatric reactrions: depersonalization (after taking the cipro but before the physically debilitating horrendous reaction), audio hallucinations, terrifying falling through bed to hell whilst falling asleep, headband excruciating headaches, suicidal ideation (while seriously disabled). I cycled and recognized the depression at first then it overtook me. I didn’t cry or feel alit of what I used to feel emotionally ttyl I was engulfed in depression last year (life events). The psychiatric floxxing was the most difficult to talk about in the throes of the floxxing. It happened after my body failed and I’ve always wondered if that’s when the Go to passed the blood brain barrier; cuz it does and not much can. I was sure I was crazy but sane enough to hide it. I’m so glad these reactions are documented now.
Do you have a link to the FDAs updated warning.
Yes, sorry. here: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s070lbl.pdf
Page 12
What does ‘institute appropriate measures’ mean?
I have been floxed many times and didn’t know it! My question is; do you know if someone that has EBV in their body at birth (I didn’t know it) and had Mono at 15, and taking lots of antibiotics throughout my life, could cause depression?
I want to know more 11mths ago I was floxed and 3mths later my kidney failed so Its been a hospital year.I am already 41.5 yrs quadriplegic now with tendon damage beyond my pain levels tolerance.I want to know more about its kidneey damage genric 750mg 3 doses I was very crippled.
— My Anecdote — I was treated in 2001 for pneumonia, and it definitely saved my life. (Other antibiotics were NOT working, and it still took an 18 day course of Levaquin.) However, I was surprised to find that I couldn’t easily get a CAT scan months later… Why? Kidneys were marginal. How were they before this?? Don’t know, but I don’t think there was a problem before this. Now in 2020, my EFGr is 55-60. Was this a cause or was it the inflammation from the pneumonia? A year later, I had a slight MCI, and had a stent. I was 52 at this time.