December 20, 2018
“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. “Certain patients are at increased risk for aortic aneurysm, including elderly patients and those with a history of blockages of the aorta or other blood vessels, high blood pressure or certain genetic conditions that involve blood vessel changes. Although the risk of aortic aneurysm or dissection is low, we’ve observed that patients are twice as likely to experience an aortic aneurysm or dissection when prescribed a fluoroquinolone drug. For patients who have an aortic aneurysm or are known to be at risk of an aortic aneurysm, we do not believe the benefits outweigh this risk, and alternative treatment should be considered. For some patients the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections, but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use. Patients and their healthcare providers need to have access to all the available safety information in order to make the best possible treatment decisions. That’s why we have continued to monitor and communicate about new safety concerns of fluoroquinolones as they become available. The FDA remains committed to keeping the risk information about these products current and comprehensive and will continue to update the public.”
The U.S. Food and Drug Administration today 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. 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.
The FDA reviewed adverse event reports and recently published observational studies showing an increased risk of aortic aneurysm or dissection associated with fluoroquinolone use, which can lead to dangerous bleeding or even death, although the risk is rare. Fluoroquinolones appear to increase the risk of aortic aneurysm and dissection by approximately twice the usual risk, although the risk is low. The reason for this increased risk cannot be determined, and the usual risk of aortic aneurysm can vary depending on the population. Patients should not stop using a prescribed fluoroquinolone before first talking to their doctor.
The FDA has communicated safety information associated with fluoroquinolone use previously including in July 2018 (significant decreases in blood sugar and certain mental health side effects), July 2016 (disabling side effects of the tendons, muscles, joints, nerves, and central nervous system), May 2016 (restrict use for certain uncomplicated infections), August 2013 (peripheral neuropathy), and July 2008 (tendinitis and tendon rupture).
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.