FDA News

FDA: Fluoroquinolones increase odds of aortic dissection, AAA rupture

The FDA issued a safety alert stating that fluoroquinolone antibiotics increase the odds of aortic dissection and ruptures of aortic aneurysms.

The agency announced it is now requiring manufacturers of fluoroquinolones to include a warning about this risk on their products’ labeling.

“Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available,” the agency wrote. “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.”

According to the alert, health care professionals should not prescribe fluoroquinolones to patients with an aortic aneurysm or at risk for one, which includes patients with peripheral atherosclerotic vascular disease, hypertension, Marfan syndrome and Ehlers-Danlos syndrome, as well as elderly patients.

The FDA issued a safety alert stating that fluoroquinolone antibiotics increase the odds of aortic dissection and ruptures of aortic aneurysms.
Source: Adobe Stock

The agency made its recommendations after reviewing relevant case reports and four observational studies showing a link between fluoroquinolone use and elevated risk for aortic dissection or aortic aneurysm rupture.

“Taken together, the results of all four studies provide consistent evidence of an association between fluoroquinolone use and aortic aneurysm or dissection,” the agency wrote. “The underlying mechanism for this risk cannot be determined from these studies, and the background risk of aortic aneurysm can vary depending on the population. Because multiple studies showed higher rates of about twice the risk of aortic aneurysm rupture and dissection in those taking fluoroquinolones, FDA determined the warnings were warranted to alert health care professionals and patients.”

The FDA issued a safety alert stating that fluoroquinolone antibiotics increase the odds of aortic dissection and ruptures of aortic aneurysms.

The agency announced it is now requiring manufacturers of fluoroquinolones to include a warning about this risk on their products’ labeling.

“Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available,” the agency wrote. “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.”

According to the alert, health care professionals should not prescribe fluoroquinolones to patients with an aortic aneurysm or at risk for one, which includes patients with peripheral atherosclerotic vascular disease, hypertension, Marfan syndrome and Ehlers-Danlos syndrome, as well as elderly patients.

The FDA issued a safety alert stating that fluoroquinolone antibiotics increase the odds of aortic dissection and ruptures of aortic aneurysms.
Source: Adobe Stock

The agency made its recommendations after reviewing relevant case reports and four observational studies showing a link between fluoroquinolone use and elevated risk for aortic dissection or aortic aneurysm rupture.

“Taken together, the results of all four studies provide consistent evidence of an association between fluoroquinolone use and aortic aneurysm or dissection,” the agency wrote. “The underlying mechanism for this risk cannot be determined from these studies, and the background risk of aortic aneurysm can vary depending on the population. Because multiple studies showed higher rates of about twice the risk of aortic aneurysm rupture and dissection in those taking fluoroquinolones, FDA determined the warnings were warranted to alert health care professionals and patients.”