Department of Health written question – answered at on 1 December 2015.
To ask the Secretary of State for Health, what discussions he has had with the Royal Colleges on the effect of macrolide antibiotics on the risk of heart failure.
Heart rhythm disturbances are a known potential side effect of macrolide antibiotics. Several observational studies have found a possible association between macrolide antibiotics and heart events. Product information for healthcare professionals and patients includes warnings about the risks of heart rhythm disturbances.
In 2015, European regulators concluded from a review of all available evidence that the risk of heart events was small. As with all medicines, the Medicines and Healthcare products Regulatory Agency continually monitors the safety of macrolide drugs and will evaluate any new data, seeking independent scientific advice from the Commission on Human Medicines and its Expert Advisory Groups as appropriate, to ensure that the balance of risks and benefits remains positive for this important class of medicines.
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