JOHNSON & JOHNSON According to the safety alert, cases of two serious brain conditions, posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), have been reported in patients taking these types of decongestant medicines.
Pseudoephedrine-containing medicines are contraindicated in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease or renal failure, as these conditions increase the risks of PRES or RCVS," reads the statement.
Symptoms of PRES and RCVS can include sudden severe headaches, nausea, vomiting, confusion, seizures, and visual disturbances.
"Patients should be advised to immediately stop using these medicines and seek medical assistance if signs or symptoms of PRES or RCVS develop," the alert warns.
"Healthcare professionals should inform patients that pseudoephedrine-containing medicines are for short-term use only, used to relieve symptoms of nasal and sinus congestion with colds, flu, and allergies," read the statement.
"Patients should be reminded to follow the instructions for use in the Patient Information Leaflet."
Patients are also advised not to take pseudoephedrine-containing medicines if they have very high or uncontrolled blood pressure, or severe kidney disease or failure, as these conditions can increase the risk of rare brain conditions.
"Patients should be alerted about the risks of PRES and RCVS associated with the use of pseudoephedrine-containing medicines," the statement highlighted
"Healthcare professionals should notify patients about these reported cases, and that PRES and RCVS are rare conditions that can involve inflammation and/or reduced blood supply to the brain."
The health authorities are urging both patients and healthcare providers to be aware of the potential risks and to closely monitor for any concerning symptoms when using pseudoephedrine-containing decongestants.
Pseudoephedrine is authorized alone or in combination with other substances for short-term symptomatic relief of nasal or sinus congestion caused by the common cold, allergic rhinitis (hay fever), or other respiratory infections.
Some examples of common pseudoephedrine-containing medicines could include Decongestant tablets or capsules with pseudoephedrine as the active ingredient, Cold/flu medications that combine pseudoephedrine with other ingredients like antihistamines or pain relievers, Nasal decongestant sprays or drops containing pseudoephedrine.
Patients should check the labels carefully for pseudoephedrine when selecting decongestant or cold/flu medicines.
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