FDA Levaquin Label Update

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. 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.

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...damaged by fluoroquinolones in 2007 at age 46. Prior to, a healthy law enforcement official. Now an amateur FQ researcher, author, and blogger.

6 Responses

  1. katieb says:

    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.

  2. Kathleen Burrows says:

    Do you have a link to the FDAs updated warning.

  3. Donna says:

    What does ‘institute appropriate measures’ mean?

  4. Deborah says:

    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?

  5. Carla Reeves says:

    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.

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