Recently, there have been more concerns about the side effects that certain cold medicines can generate. Therefore, they want certain changes to be made in pharmacies.
Certain medicines that include pseudoephedrine have been the subject of proposals for change within the European Medicines Agency (EMA) PRAC Committee responsible for the assessment of pharmacovigilance risks. The proposals are for adjustments in the information associated with them.
These recommendations are designed to promote a more efficient and transparent approach to the safe use of these medicines.
The decision comes at a time when concerns about the safety of these pseudoephedrine-containing cold medicines have grown, particularly regarding possible neurological and cardiac side effects.
How cold drug therapies will change
In February, European Medicines Agency began a detailed review of decongestant drugs used in the treatment of colds and flu.
This initiative was prompted by reports of cerebrovascular events in some patients who used drugs containing pseudoephedrine.
The purpose of the review is to provide a comprehensive and accurate assessment of the risks associated with these drugs. But also to identify possible additional safety measures necessary to protect the health of patients.
The main concerns center on the possibility of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Two conditions associated with changes in blood vessels in the brain.
Some treatments can put patients’ lives at risk
Patients affected by PRES and RCVS may experience reduced blood flow to the brain (ischemia). This can in some cases lead to significant complications, even life-threatening.
Common symptoms associated with these conditions include headache, nausea, and seizures.
Pseudoephedrine is administered by ingestion. The substance is used alone or in combination with other medicines to treat nasal congestion caused by viral infections, flu or allergies.
Medicines in the pharmacy. Photo source: EVZ Archive
The substance works by activating nerve endings to release noradrenaline, a chemical that induces vasoconstriction (narrowing) of blood vessels.
This reduces the amount of fluid released from the blood vessels, which leads to less edema and less mucus production in the nasal mucosa.
These pseudoephedrine medicines are authorized in various EU states
Drug products containing pseudoephedrine are associated with a recognized risk of ischemic cardiovascular and cerebrovascular events, including adverse reactions involving ischemia of the heart and brain, such as stroke and myocardial infarction.
Information on these risks is already included in the drug product details, with the aim of reducing these possible dangers.
In various member countries of the European Union, medicines that include pseudoephedrine are authorized, and may contain pseudoephedrine as a single ingredient or in combination with other active substances.
These medicines are used to treat symptoms associated with colds and flu, such as migraines, fever, pain or allergic rhinitis (inflammation of the nasal passages) in people who suffer from nasal congestion.
2023-12-04 20:36:47
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