In July 2018, From the Labs released a post on the laboratory evidence suggesting that in a mouse model of moderately stressed aortas, exposure to the antibiotic ciprofloxacin results in aortic aneurysms and dissections progressing more rapidly and more severely than in unstressed mouse aortas.
These findings support the concerns raised by previous retrospective clinical studies and suggest that ciprofloxacin and other antibiotics of the same class of fluoroquinolones should be used with caution in patients with aortic dilatation.
One of the take-home messages of the team of researchers led by Dr. Scott A. LeMaire and Dr. Ying H. Shen was that enough evidence had been gathered to support changing guidelines on the use of fluoroquinolone antibiotics for people who have, or are at risk for getting, an aneurysm. The researchers hoped that these guidelines could be changed in short order.
Fast forward to October, and the work of the Baylor researchers has begun to have international impact. On Monday, Oct. 1, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (the European Union’s version of the FDA) published its recommendations to amend product information for fluoroquinolones related to the risk of aortic aneurysms and dissections, citing the study by LeMaire and his colleagues, as well as epidemiological studies by other groups, as supporting evidence. (See pages 6-7 for more information).
“We were gratified to learn that the European Medicines Agency has recommended major changes to the product information for fluoroquinolones throughout the European Union,” LeMaire said. “Importantly, this information will warn physicians and patients of the risk of lethal aortic problems related to these antibiotics. We expect that the resulting refinements in prescribing practices will save lives.”
For more details on the research behind the connection between ciprofloxacin and increased risk of severe aortic problems, read the paper by LeMaire, et al in JAMA Surgery and the original post in From the Labs, “The dark side of antibiotic ciprofloxacin.”
Dr. Scott A. LeMaire is director of research in the division of cardiothoracic surgery, vice-chair for research and professor of surgery and of molecular physiology and biophysics at Baylor College of Medicine.