German Health Authority – Federal Institute for Drugs and Medical Devices, released a safety alert for fluoroquinolone antibiotics for the potential risk of heart valve regurgitation. This is a direct healthcare professional communication released by marketing authorisation holder of respective medicinal products in liaison with European Medicines Agency (EMA) to inform health care professionals on this new risk for exercising a special caution while performing benefit risk assessment before using fluoroquinolone antibiotics.

Fluoroquinolones belongs to the class of quinoline antibiotics which are broad spectrum and used in the treatment and prevention of bacterial infections. Medicinal products coming under this class are ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin).

A rigorous benefit-risk analysis needs to be performed before using fluoroquinolones because of risks of acute aortic events which included aortic aneurysm and dissection. The results of a recent epidemiological study conducted by Mahyar Etminan et al., showed an increased risk of mitral and aortic regurgitation in patients taking systemic fluoroquinolones compared with patients taking other antibiotics such as amoxicillin or azithromycin.

Strong causal association: The case reports (which were reported by health care professionals) pertaining to heart valve regurgitation in patients treated with the fluoroquinolones has a documented causal association of Probable or Possible. This data demonstrated that fluoroquinolones could cause heart valve regurgitation/incompetence.

David G Guzzardi et al., conducted a laboratory study for identifying the possible cellular mechanism responsible for adverse aortic clinical events associated with fluoroquinolones use. This study showed a decreased expression of aortic cell TIMP-1 (tissue inhibitors of matrix metalloproteinases) in human aortic myofibroblasts exposed to fluoroquinolone antibiotics and impaired compensatory collagen-1 expression resulting in human aortic myofibroblast-mediated extracellular matrix dysregulation. This study established a clinical relationship for fluoroquinolone antibiotics and acute aortic events. Collagen degradation has also been postulated for fluoroquinolone-associated disorders of tendons and the aorta.

Risk factors for increased risk of heart valve regurgitation/incompetence with the use of fluoroquinolone antibiotics:

  • Congenital or pre-existing heart valve disease
  • Connective tissue disorders – Marfan syndrome or Ehlers-Danlos syndrome,
  • Turner syndrome
  • Bechet’s disease
  • Hypertension
  • Rheumatoid arthritis
  • Infective endocarditis.

Important information for health care professionals:

Be aware of this potential risk of heart valve regurgitation with the use medicinal products belonging to the drug class – fluoroquinolone antibiotics.

A careful benefit-risk analysis is strictly recommended for the use of systemic and inhaled fluoroquinolone antibiotics in patients with the above risk factors for heart valve regurgitation/incompetence and should only be used after consideration of alternative therapeutic treatment options.

Inform patients to observe for any potential signs/symptoms of this risk which include –

  • Shortness of breath (acute dyspnoea)
  • Heart palpitations
  • Oedema development – abdomen or lower extremities

Advise patients/patient care providers to seek immediate medical attention in case in the identification of above symptoms.

Voluntary ADR reporting

Every medicinal product has both benefits and risks. There is no single pharmaceutical product which is completely free from side effects/adverse reactions. All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority. This would accumulate safety evidence for medicinal products which in turn facilitates health authorities to take regulatory actions at the earliest possibility for a better patient safety.

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