MHRA Highlights Risk of Heart Valve Regurgitation with Fluoroquinolones

Pavankumar Kamat

December 29, 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update highlighting a small risk of heart valve regurgitation with the use of systemic and inhaled fluoroquinolones.

The update follows a European review of epidemiological and non-clinical studies which indicated an increased risk of heart valve regurgitation after the use of fluoroquinolones. A US case-control study found a two-fold increase in the relative risk of mitral or aortic regurgitation with current oral fluoroquinolone use vs the use of amoxicillin or azithromycin. Another non-clinical study reported increased collagen degradation in heart muscle cells with exposure to ciprofloxacin.

Fluoroquinolones have been earlier associated with a small increased risk of aortic aneurysm and dissection and with an increased risk of adverse effects on the musculoskeletal and nervous system.

Clinicians are advised to prescribe fluoroquinolones only after careful benefit-risk assessment and after consideration of alternative therapeutic options in the following patient populations:

  • those with congenital or pre-existing heart valve disease;

  • those with connective tissue disorders (e.g. Marfan syndrome or Ehlers-Danlos syndrome);

  • those with other risk factors or predisposing conditions for heart valve regurgitation (e.g. hypertension, Turner’s syndrome, Behçet’s disease, rheumatoid arthritis and infective endocarditis).

Clinicians should advise patients to seek immediate medical attention if they experience:

  • rapid onset of dyspnoea, particularly when lying down flat in bed;

  • swollen ankles, feet or abdomen;

  • new-onset heart palpitations.

The product information for these drugs is being updated to reflect the increased risk of heart valve regurgitation.

This article originally appeared on Univadis, part of the Medscape Professional Network.

 

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