The US Food and Drug Administration (FDA) announces that a FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called 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.
Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available. 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. FDA is requiring that a new warning about this risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones.
Health care 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.
- Prescribe fluoroquinolones to these patients only when no other treatment options are available.
- 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.
- Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to their health care professional immediately.
- Before starting an antibiotic prescription, inform their health care professional if they have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.
- If they have been prescribed a fluoroquinolone to treat an infection, do not stop the antibiotic without first talking to their health care professional.
FDA reviewed cases reported to the FDA Adverse Event Reporting System (FAERS) and four published observational studies that showed an increased risk of aortic aneurysm or dissection associated with fluoroquinolone use. How some of the studies were designed or carried out, and the ways the data were analyzed could affect the study findings; however, taken together, the results of all four studies provide consistent evidence of an association between fluoroquinolone use and aortic aneurysm or dissection. The underlying mechanism for this risk cannot be determined from these studies, and the background risk of aortic aneurysm can vary depending on the population. The background risk has been estimated from nine aortic aneurysm events per 100,000 people per year in the general population to 300 aortic aneurysm events per 100,000 people per year in individuals at highest risk. Because multiple studies showed higher rates of about twice the risk of aortic aneurysm rupture and dissection in those taking fluoroquinolones, FDA determined the warnings were warranted to alert health care professionals and patients.
List of FDA-approved systemic fluoroquinolones include moxifloxacin, delafloxacin, ciprofloxacin, ciprofloxacin extended-release, gemifloxacin, levofloxacin and ofloxacin.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm628753.htm
In Hong Kong, there are 188 registered pharmaceutical products containing fluoroquinolones which are oral preparations or injectables for use in human, including ciprofloxacin (81 products), levofloxacin (62 products), moxifloxacin (6 products), norfloxacin (7 products), ofloxacin (30 products), prulifloxacin (1 product) and sparfloxacin (1 product). All products are prescription-only medicines. So far, the Department of Health has received 4 cases of adverse drug reaction related to levofloxacin and 1 case related to moxifloxacin, but these cases are not related to aortic aneurysm and dissection.
Related news was previously issued by Medicines and Healthcare products Regulatory Agency (MHRA) and was posted on the Drug Office website on 15 Nov 2018. Letters to inform local healthcare professionals were also issued on the same day. In light of the MHRA and above FDA’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, December 21, 2018
Issued at HKT 17:30
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