The Medicines Agency warns of new contraindications and warnings concerning pseudoephedrine-based drugs.
When will they be permanently banned? This is the question we ask ourselves when reading the mail sent by the National Medicines Agency (ANSM) to general practitioners, allergists, ENT doctors, pharmacists, neurologists, emergency physicians and pulmonologists, on February 12. In this letter, the authority informs healthcare professionals of new contraindications and warnings added to the instructions for medicines containing pseudo-ephedrine. Pseudoephedrine is authorized, alone or in combination with other substances, for the symptomatic relief of nasal congestion (stuffy nose) or sinus caused by common coldrhinitis allergicvasomotor rhinitis or otitis barotraumatic. However, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), which are serious conditions affecting the brain’s blood vesselshave been reported in patients taking these medications.
Beware of “thunderclap” headaches
The symptoms of these serious side effects appear acutely, in hours or days which follow the catch. These include sudden and severe headache, nausea, vomiting, confusion, seizures and/or visual disturbances. But above all, in the case of reversible cerebral vasoconstriction syndrome, a “thunderclap” headache occurs. This is characterized by a severe pain at the head reaching its peak in secondsusually bilateral (both sides), with a posterior onset (behind the head) followed by pain diffuse frequently accompanied by nausea, photophobia (difficulty tolerating light) and phonophobia (difficulty tolerating sound). “Patients should be advised of the need forstop using these medications immediately and seek medical attention if signs or symptoms of PRES or RCVS appear.” indicates the health agency which recommends against the use of pseudo-ephedrine-based medications in cases of colds. Although most cases resolved after stopping treatment and there were no deaths, the ANSM recalls that the major complications of RCVS syndrome include ischemic and hemorrhagic strokes. In conclusion, she believes that “Newly identified risks of PRES or RCVS should be considered as part of the overall safety profile of pseudoephedrine, which also includes the cardiovascular and cerebrovascular ischemic events“.