FDA Announces MedWatch Alert for Fluoroquinolone Antibiotics

A US Food and Drug Administration (FDA) review has found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years. 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.

Healthcare professionals should 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. Additionally, the FDA is recommending healthcare professional prescribe fluoroquinolones to these patients only when no other treatment options are available and advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm. Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.

Patients should seek medical attention immediately by going to an emergency room or calling 911 if they experience sudden, severe, and constant pain in the stomach, chest or back. Patients should be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so it is recommended they report any unusual side effects from taking fluoroquinolones to their health care professional immediately.

Patients should inform their health professional before starting an antibiotic prescription, if the patient has a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.

Patients should not stop the antibiotic without first talking to their health care professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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