The European Medicines Agency (EMA) has published a Direct Healthcare Professional Communication (DHPC) containing important information for healthcare professionals who prescribe medicinal products containing pseudoephedrine.
Dear healthcare professional!
Registration certificate holders (RCHs) of medicinal products containing pseudoephedrine (pseudoephedrine), in agreement with the European Medicines Agency (EMA), and the [National Competent Authority] inform you of the following:
Brief overview
- Several cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of medicinal products containing pseudoephedrine.
- Medicinal products containing pseudoephedrine are contraindicated in patients with severe or uncontrolled arterial hypertension, as well as with severe acute or chronic kidney disease or renal failure, since these conditions increase the risk of PRES or RCVS.
- Symptoms of PRES and RCVS include sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.
- Patients should be advised to stop using these medicinal products immediately and seek medical attention if signs or symptoms of PRES or RCVS develop.
Background information on safety issues
Pseudoephedrine is authorized alone or in combination with other substances for short-term symptomatic relief of nasal or sinus congestion caused by a cold or allergic rhinitis <or vasomotor rhinitis> <or aerotitis>.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), which are serious conditions affecting the blood vessels of the brain, have been reported in patients who took medicinal products containing pseudoephedrine. Most of the recorded cases resolved after discontinuation and appropriate treatment. No fatal cases of PRES or RCVS have been reported.
Following a Europe-wide review of case reports and other available data to assess the risks of PRES and RCVS associated with the use of medicinal products containing pseudoephedrine, it was concluded that pseudoephedrine is associated with the risks of PRES and RCVS, and that the instructions for medical use should be updated to include information on these adverse reactions and risk minimization measures.
The recently identified risks of PRES or RCVS should be considered in the context of the overall safety profile of pseudoephedrine, which also includes other cardiovascular and cerebrovascular ischemic events.
Overview of PRES and RCVS
PRES can manifest with a wide range of acute or subacute neurological symptoms, including headache, altered mental status, seizures, visual disturbances and/or focal neurological deficit. An acute or subacute onset of symptoms (from several hours to several days) is typical. PRES is usually reversible; symptoms resolve within several days or weeks after blood pressure is lowered and the medicinal products that caused it are discontinued.
RCVS usually presents with a thunderclap headache (severe pain that peaks within seconds), typically bilateral, with posterior onset, followed by diffuse pain, often accompanied by nausea, vomiting, photophobia and phonophobia. Some patients may experience transient focal deficits. Ischemic and hemorrhagic stroke are the main complications of the syndrome.
Call to report
Healthcare professionals are encouraged to report adverse reactions associated with the use of medicinal products containing pseudoephedrine to the [National Competent Authority] <In accordance with the requirements of the Pharmacovigilance Procedure approved by order of the Ministry of Health of Ukraine of December 27, 2006 No. 898, registered with the Ministry of Justice of Ukraine on January 29, 2007 under No. 73/13340, all suspected adverse reactions should be reported to the State Expert Center of the Ministry of Health of Ukraine via the link: https://aisf.dec.gov.ua/>
The full (original) text of the communication to healthcare professionals on the safety of medicinal products containing pseudoephedrine is available at the link:
