The U.S. Food and Drug Administration warned on Thursday that the benefits of fluoroquinolone antibiotics do not outweigh the risks, which include an aortic aneurysm that can lead to dangerous bleeding or even death.
The FDA said a review found that tears, called aortic dissections, or ruptures of an aortic aneurysm can occur with systemic use of fluoroquinolones by mouth or through an injection.
Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available, the FDA warned.
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 FDA.
FDA officals said they are requiring that a new warning about this risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones.
Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years, according to the FDA.
They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems, according to the FDA.
The FDA advised 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 peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.
For more information, visit the FDA website.