Risk of valvular heart disorders with systemic + inhaled FQs
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Risk of valvular heart disorders with systemic + inhaled FQs Systemic and inhaled fluoroquinolones (FQs)* are linked with a potential increased risk of heart valve regurgitation/ incompetence, says Feroze Nazneen from Krka Pharma Dublin. In agreement with the EMA and Ireland’s Health Products Regulatory Authority, a number of marketing authorisation holders (including Krka Pharma Dublin) issued a "Dear Healthcare Professional" letter regarding the above-mentioned safety risk. A recent epidemiological study indicated a two-fold increase in the risk of mitral and aortic regurgitation in patients who were treated with systemic FQs, versus other antibacterials (amoxicillin or azithromycin). Ms Nazneen noted that "several medically confirmed cases of heart valve regurgitation/incompetence affecting any heart valve have been reported in patients receiving fluoroquinolones with probable or possible causal association. These data indicate that fluoroquinolones can cause heart valve regurgitation/incompetence". Furthermore, data from a laboratory study have indicated that exposure to ciprofloxacin led to degradation of collagen in aortic myofibroblast cells, which may lead to heart valve regurgitation/incompetence. Ms Nazneen added that "collagen degradation has also been postulated for fluoroquinolone-associated disorders of tendons and the aorta". There are a number of conditions or factors that are associated with an increased risk of heart valve regurgitation/ incompetence, including: • congenital or pre-existing heart valve disease; • connective tissue disorders (e.g. Marfan syndrome, Ehlers-Danlos syndrome); • Turner syndrome; • Behcet’s disease; • hypertension; • rheumatoid arthritis; and • infective endocarditis. In patients at risk of heart valve regurgitation/incompetence, use of systemic and inhaled FQs should only be used after careful benefit-risk assessment and after consideration of other therapeutic options. Healthcare professionals should advise their patients to seek immediate medical attention if they develop acute dyspnoea, new onset of heart palpitations, or develop oedema of the lower abdomen or lower extremities. * including ciprofloxacin-, delafloxacin-, moxifloxacin-, levofloxacin- and ofloxacin-containing products. Nazneen F. Direct Healthcare Professional Communication: Systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence. Internet Document : 29 Oct 2020. Available from: URL: https://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---systemic-and-inhaled803517195 fluoroquinolones0d4c0e2697826eee9b55ff00008c97d0.pdf?sfvrsn=0
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Reactions 21 Nov 2020 No. 1831
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