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On December 20, 2018, FDA issued a warning that fluoroquinolones administered orally or intravenously may increase the risk of ruptures or tears in the main artery of the body, also known as the aorta, in certain patients. Fluoroquinolones are antibiotics labeled to treat certain bacterial infections by killing bacteria or inhibiting bacterial growth. Currently available fluoroquinolones are ciprofloxacin, delafloxacin, gemifloxacin, levofloxacin, moxifloxacin, and ofloxacin. Ruptures of an aortic aneurysm or aortic dissections are rare but can cause severe bleeding and death. The estimated risk of aortic ruptures or tears in the general population is 9 events per 100,000 people per year and 300 events per 100,000 people per year in high-risk patients. FDA reviewed case reports from the FDA Adverse Event Reporting System (FAERS) and 4 epidemiological studies that suggested a 2-fold increased risk of aneurysm or dissection associated with fluoroquinolone use. The review could not determine the mechanism of the increased risk.
FDA is requiring inclusion of the new risks in the prescribing information and patient Medication Guide for all fluoroquinolones. Health care providers should avoid prescribing fluoroquinolones to high-risk patients and should only prescribe fluoroquinolones if no alternative therapy is available. Avoid fluoroquinolones in patients with a history of aneurysms or blockages of the aorta or blood vessels, high blood pressure, genetic disorders that affect blood vessels (eg, Marfan or Ehlers-Danlos syndrome), and in the elderly. Remind patients to seek immediate help if symptoms occur suggesting aortic aneurysm or dissection. Patients should seek emergency treatment if they experience signs or symptoms of sudden, severe, and constant stomach, chest, or back pain after taking fluoroquinolones. Report side effects involving fluoroquinolones or other medications to the FDA MedWatch program. FDA previously reported other safety information regarding fluoroquinolones:
- July 2018 (significant drop in blood sugar and mental health adverse effects)
- July 2016 (adverse effects of the central nervous system, joints, muscles, nerves, and tendons)
- May 2016 (avoid use in specific uncomplicated infections), August 2013 (peripheral neuropathy)
- July 2008 (tendon rupture and tendinitis).
FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. Distribution requirements and exceptions (eg, certain inpatient care situations) for Medication Guides are addressed in an FDA Guidance Document: www.fda.gov/Drugs/DrugSafety/ucm085729.htm. Medication Guide distribution requirements are stricter for medications with a Risk Evaluation and Mitigation Strategy (REMS) that includes Elements To Assure Safe Use (ETASU) with specific requirements for providing and reviewing the Medication Guide: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/. A complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
Additional information:
- FDA MedWatch Alert – December 20, 2018
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm628960.htm - FDA Drug Safety Communication – December 20, 2018
www.fda.gov/Drugs/DrugSafety/ucm628753.htm