'Potentially fatal' antibiotic fears prompt guidance re-think
Clinical Safety warnings for azithromycin may be strengthened by the EMA following the a study that found those on the antibiotic had an increased risk of heart problems
EU drugs regulators are considering whether to update guidance for the prescribing of the antibiotic azithromycin, as the US issued fresh warnings about the risk of heart problems.
The European Medicines Agency (EMA) would assess whether to strengthen its safety warnings for the antibiotic, it said this week, after the US Food and Drug Administration (FDA) issued a public warning on Tuesday that azithromycin could lead to a "potentially fatal irregular heart rhythm".
A study has found that patients on a five-day course of azithromycin are at increased risk of heart problems |
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Drug labels for the antibiotic had been updated, the FDA said, as it warned healthcare professionals to consider the risks when deciding on treatment options for those already suffering with heart problems. |
The FDA's warning followed the review of a study published in the New England Journal of Medicine in May last year, which found that those on a five-day course of azithromycin had an increased risk of death compared with those treated with amoxicillin, ciprofloxacin or no drug.
The EMA told C+D that its ongoing assessment of the drug would involve considering whether prescribing information needed updating and that it would consider the US label update at a meeting next month.
And the MHRA said that UK prescribing information, which was updated last month, warned that "a risk of heart disorders cannot be ruled out and caution is advised when treating patients who are predisposed to heart conditions".
"Patients should continue to use azithromycin as prescribed and discuss any concerns they may have with their healthcare professional," a spokesperson said.
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