Other safety alerts
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| The United Kingdom: Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces the risk of heart valve regurgitation associated with the use of systemic and inhaled fluoroquinolones.
A European review has considered data from epidemiological and non-clinical studies indicating an increased risk of heart valve regurgitation after use of fluoroquinolones. An epidemiological study suggested an increased risk of aortic and mitral regurgitation associated with fluoroquinolone usage. The case-control study of United States patient records retrospectively examined a cohort of 12,502 patients with valvular regurgitation (after excluding patients with other conditions that may be associated with valvulopathy). Prescriptions of oral fluoroquinolones were compared with those of amoxycillin within this group and within a control cohort of 125,020 people. Patients with mitral or aortic regurgitation were nearly twice as likely to have been exposed to fluoroquinolones (2.4% of cases) than to amoxycillin (1.6% of cases). The study reported an adjusted rate ratio for current fluoroquinolones use versus amoxicillin use of 2.40 (95% CI 1.82 to 3.16) and versus current azithromycin use of 1.75 (95% CI 1.34 to 2.29). A non-clinical study also reported that ciprofloxacin increases collagen degradation in heart muscle cells. These findings indicate that systemic or inhaled fluoroquinolones might contribute to heart valve regurgitation, particularly in patients with pre-existing risk factors.
The increased risk of heart valve regurgitation has been added to the product information for these medicines and a letter sent to relevant healthcare professionals in the United Kingdom.
Heart valve regurgitation, also called heart valve incompetence or insufficiency or leaking valve, occurs when blood flows back through the valves as they are closing or when they should be completely closed.
The risk of heart valve regurgitation is increased in the presence of risk factors such as pre-existing congenital heart valve disease or other risk factors or conditions predisposing for heart valve regurgitation, including connective tissue disorders (for example, Marfan syndrome, Ehlers-Danlos syndrome), hypertension, Turner’s syndrome, Behcet’s disease, rheumatoid arthritis, and infective endocarditis. Some people with heart valve regurgitation may experience symptoms of heart failure, including: shortness of breath, especially when lying down flat in bed; swelling of the ankles, feet, or abdomen; new-onset heart palpitations.
Advice for healthcare professionals:
- Fluoroquinolones are authorised for use in serious, life-threatening bacterial infections systemic (by mouth or injection) and inhaled fluoroquinolones have been associated with a small increased risk of heart valve regurgitation, with one retrospective case-control study suggesting a 2-fold increased relative risk with current oral fluroquinolone use compared with the risk with use of amoxicillin or azithromycin.
- Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in the following patients at risk: patients with congenital heart valve disease or pre-existing heart valve disease; patients diagnosed with connective tissue disorders (for example, Marfan syndrome or Ehlers-Danlos syndrome); patients with other risk factors or conditions predisposing for heart valve regurgitation (for example, hypertension, Turner’s syndrome, Behçet’s disease, rheumatoid arthritis, and infective endocarditis).
- Advise patients, especially those at risk, of the importance of seeking immediate medical attention if they experience: a rapid onset of shortness of breath, especially when lying down flat in bed; swelling of the ankles, feet, or abdomen; new-onset heart palpitations.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/systemic-and-inhaled-fluoroquinolones-small-risk-of-heart-valve-regurgitation-consider-other-therapeutic-options-first-in-patients-at-risk
In Hong Kong, there are registered pharmaceutical products containing systemic fluoroquinolones for use in human, including ciprofloxacin (67 products), levofloxacin (54 products), moxifloxacin (7 products), norfloxacin (5 products), ofloxacin (22 products) and prulifloxacin (1 product). All products are prescription-only medicines. So far, the Department of Health (DH) has received 7 cases of adverse drug reaction related to levofloxacin and 1 case related to moxifloxacin, but these cases are not related to heart valve regurgitation.
Related news was previously issued by Taiwan Food and Drug Administration, and was posted on the Drug Office website on 4 Dec 2020. Letters to inform local healthcare professionals were issued by the DH on the same day. In light of the above MHRA’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Dec 18, 2020
Issued at HKT 17:00
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