The Food and Drug Administration (FDA) issued a Drug Safety Communication warning health care professionals to avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with a history of blood vessel blockages or aneurysms, high blood pressure, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.
Fluoroquinolones 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 that involve blood vessel changes, and the elderly.
“FDA is committed to protecting patients’ health by keeping the public informed and engaged about the risks and benefits of certain drugs. Today we’re warning patients and healthcare providers that fluoroquinolones can increase the occurrence of rare but serious ruptures or tears in the main artery of the body, called the aorta, which can lead to dangerous bleeding or even death,” said FDA Commissioner Scott Gottlieb, M.D.
FDA is requiring that a new warning about this risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones.
The FDA encourages patients to talk to their health care professional about the use of fluoroquinolone antibiotics and to reserve these treatments for only life-threatening bacterial infections given their risk profile.