PRAC assessment highlights CV risks with erythromycin products
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PRAC assessment highlights CV risks with erythromycin products Data from observational studies show that there is "a rare, short-term risk of cardiovascular events associated with macrolides, including erythromycin", says Ireland’s HPRA.* The agency recently issued updated warnings after the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) considered the above-mentioned study data as part of a routine periodic assessment of erythromycincontaining medicines. The specific cardiovascular (CV) events mentioned in these updated warnings included arrhythmia, myocardial infarction and CV-related mortality. The PRAC has recommended that healthcare professionals should balance the CV risks with known treatment benefits when prescribing erythromycin-containing medicines. In addition, the HPRA noted that "as part of the PRAC’s assessment, an extensive literature review was undertaken and it was considered that there was consistent evidence across a reasonable body of literature to support an association between exposure to erythromycin in infants and the risk of infantile hypertrophic pyloric stenosis (IPHS)". Specifically, epidemiological data (including three meta-analyses) have suggested a 2- to 3-fold increase in the risk of IPHS in children aged
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