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.