Fluoroquinolones: old drugs, putative new toxicities.

INTRODUCTION: Fluoroquinolone (FQ) antibiotics were approved in 1986 for treatment of urinary tract infections, sinusitis, and bronchitis. Numerous putative FQ-associated adverse events have been recently reported. AREAS COVERED: We review international regulatory agency experience with these FQ-associated toxicities. A 2015 FDA Advisory Committee meeting led regulatory agencies in Canada, Australia, the European Union, New Zealand, and Japan between 2017 and 2021 to evaluate FQ-associated long-term disability and aortic aneurysm/dissections. Regulatory agency guidance in the United States in 2016 warn that FQs should not be used as first-line therapies for urinary tract infections, sinusitis, and bronchitis if other antibiotics are available because of potential long-term and disabling toxicity. Regulatory agencies in European Union countries warn that FQs should not be used to treat mild infections. Product labels in Australia, New Zealand, Japan, and Canada do not have warnings related to FQ-associated disability. Revised product labels and public health advisories in the United States, the European Union, and Japan warn against FQ administration to persons at aortic aneurysm/dissection risks, while product labels and regulatory agency notifications from Canada, Australia, and New Zealand do not include these warnings. EXPERT OPINION: Harmonization of warnings related to FQ-associated disability in particular should be considered.

Fluoroquinolone-Associated Disability and Other Fluoroquinolone-Associated Serious Adverse Events: Unexpected Toxicities Have Emerged in Recent Years.

This study describes cases of individuals who report adverse events following consumption of the most commonly prescribed fluoroquinolone (FQ) antibiotics: ciprofloxacin, levofloxacin, or moxifloxacin. Fluoroquinolone (FQ) antibiotics are some of the most widely prescribed antibiotics in the world. Although these antibiotics have been on the market for more than 20 years, a wide range of serious FQ-associated adverse events first became apparent in 2006 and continued to be recognized for the next 15 years.

Moderna, Pfizer-BioNTech, and Johnson & Johnson/Janssen Post-Covid Vaccine Hematological Adverse Events Including Cerebral Venous Sinus Thrombosis (CVST), Thrombotic Thrombocytopenia (VITT), Blood Clots, Increased Vaginal/Menstrual Bleeding and/or Miscarriage, Stillbirth Delivery, or Premature Birth.

The Centers for Disease Control (CDC) indicated in 2021 that it would monitor for possible post-COVID-19 vaccination coagulopathy adverse events (AEs).