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).
In the U.S., the FDA stated in December a formal warning that these antibiotics should not be used in patients at increased risk unless there are no other treatment options available.
People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders such as Marfan Syndrome and Ehlers-Danlos syndrome, and the elderly. The FDA has required that the warning about this risk be added to the prescribing information and patient Medication Guide for all these antibiotics.
“We are gratified that the FDA has joined the European Medicines Agency in releasing a formal warning related the harmful effects that these drugs can have on the aortic wall in patients at risk for aortic dissection or rupture,” LeMaire said. “Importantly, our additional observational study suggested that 20 percent of patients with a diagnosis of aortic aneurysms or dissection receive these drugs during their hospitalization, an alarmingly high rate given the potential catastrophic consequences. The importance of communicating this new warning to patients and healthcare providers cannot be overstated.”
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.