The European Medicines Agency (EMA) announces a safety review of some flu drugs, which would pose a risk of ischemia and heart attack.
A European Medicines Agency (EMA) committee said on Friday it had begun a review of decongestant cold and flu drugs containing pseudoephedrine following safety concerns.
The EMA said the review follows reports of conditions affecting blood vessels in the brain in some patients who took medicines containing pseudoephedrine.
According to the EMA, the concerns are related to the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions that affect blood vessels in the brain. PRES and RCVS can involve reduced blood supply (ischemia) to the brain and cause major complications.
“Medicines containing pseudoephedrine carry a known risk of ischemic cardiovascular and cerebrovascular events (side effects involving ischaemia of the heart and brain), including stroke and heart attack,” the EMA website states.
Pseudoephedrine is a medicine used alone or in combination with other medicines to treat nasal congestion due to colds, flu, or allergies.
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