Fluoroquinolones, which have been used as antibiotics for 30 years, increase the risk of aortic dissection. Recent studies have finally confirmed the causal relationship between the drug and vascular aneurysm. The main conclusion: fluoroquinolones should not be used in patients with increased cardiovascular risk.
What is the relationship between aortic dissection and fluoroquinolones?
10 years ago, it was revealed that fluoroquinolones increase the risk of tendon rupture. The complication is due to impaired collagen formation, an important component of tendons and blood vessels.
In 2015, Taiwanese scientists reported that people who had an aortic aneurysm often took fluoroquinolones. At that time, the FDA concluded that the study had significant flaws. Therefore, experts refused to place safety precautions in the instructions.
An analysis of the FAERS database, which collects adverse drug reactions, revealed 15 spontaneous reports from doctors. However, all patients had other risk factors for aortic dissection.
These include smoking, males, old age, high blood pressure, or atherosclerosis. Therefore, the FDA also did not issue a warning this time.
3 other epidemiological studies have come to similar conclusions. The studies compared patients older than 50 years who received fluoroquinolones with those who received amoxicillin. Result: after administration of the fluoroquinolone antibiotic, aortic dissection was found 66% more often in the first 60 days.
Nick Deynman came to the conclusion that elderly people who received fluoroquinolone are more often diagnosed with aortic aneurysm.
Chien-Chan Lee was able to confirm earlier results in the so-called "self-controlled study." She compared different phases of the life of the same patients. In the first 60 days after the administration of the fluoroquinolone antibiotic, the risk of aortic dissection was almost 3 times higher.
In a new analysis, the FDA identified another 56 cases in its FAERS database. However, these patients also had other risk factors for aneurysm or aortic dissection. Most of these cases were reported by patients seeking moral compensation through the courts.
Overall, the FDA estimates that fluoroquinolones increase the risk of aortic aneurysms. Doctors are advised to avoid prescribing these antibiotics to patients with an increased risk of vascular accidents.
According to the FDA, these include patients with peripheral arterial disease, arterial hypertension, and genetic disorders. The risk group should be prescribed fluoroquinolone antibiotics only if there are no other treatment options. Patients are advised to consult a doctor at the slightest sign of aortic dissection. You should also immediately call an ambulance if acute symptoms of rupture of the vessel appear.
The risk of aneurysms and aortic dissection varies widely depending on the risk group. Reported from 9 cases of aortic aneurysm per 100,000 people in the general population. Up to 300 cases of aortic aneurysm per 100,000 people are observed in the high-risk group (aged about 85 years).
What other side effects do these antibiotics cause?
The FDA has published several articles on the safety of fluoroquinolones over the past 10 years. In July 2008, attention was drawn to the risk of tendonitis and tendon rupture. In August 2013, a warning about peripheral neuropathy followed.
In May 2016, indications were limited for uncomplicated infections.
In July 2016, side effects were observed on tendons, muscles, joints, nerves and the brain. In July 2018, a warning appeared about hypoglycemia and some psychiatric side effects. EMA is currently conducting a security audit.
When is it strictly forbidden to use fluoroquinolones?
The main contraindication, if there are other antibiotics, is a mild to moderate infection. All patients with uncomplicated cystitis, acute bronchitis, or otitis media are advised to consult a doctor for another antibiotic. The potential risk does not outweigh the health benefits.
Certain patient groups, according to PRAC, are at a higher risk of aortic dissection. New recommendations will be sent to the European Commission for a final decision.
