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WASHINGTON -- Manufacturers of fluoroquinolones such as ciprofloxacin (Cipro) must now warn about risk of aortic dissection or aneurysm in certain patients associated with systemic use of these antibiotics, .
It's the latest in a series of warnings related to this class of antibiotics. In July, the FDA required manufacturers to update labeling to warn about mental health issues and potential low blood sugar adverse reactions; and before that, the agency had warned about adverse musculoskeletal effects and peripheral neuropathy. The FDA had also indicated that this class of agents should not be used for uncomplicated infections owing the risk of adverse effects.
It also represents a backtrack from a , in which the FDA, responding to reports of a possible aneurysm risk, said it could not find solid evidence to support them.
In Thursday's statement, the agency said a review found fluoroquinolones were linked to "an increase in occurrence" of aortic dissections. The review included cases reported to the FDA Adverse Event Reporting System, as well as four observational studies that hazard or odds ratios of about 2 to 3 among users of fluoroquinolones relative to the general population. "[T]he results of all four studies provide consistent evidence of an association between fluoroquinolone use and aortic aneurysm or dissection," the FDA said. However, the agency also noted that the background risk of aortic aneurysm is very low: about 9 per 100,000 overall up to 300 per 100,000 in high-risk groups such as the very elderly.
The new label warning states that fluoroquinolones should not be used in patients "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." These warnings must be added to the prescribing information and the patient medication guide, the FDA said.
Moreover, the FDA said that healthcare professionals should avoid prescribing these antibiotics to patients with aortic aneurysm or those at risk for aortic aneurysm, unless no other treatment options are available. These patient groups at increased risk include "patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients," the agency said.