Infarmed warns about the risks of using drugs with pseudoephedrine for hypertensive patients and patients with kidney disease

Infarmed recommends that patients with hypertension and kidney disease not take medications containing pseudoephedrine used to relieve cold and flu symptoms such as headaches, fever and pain, allergic rhinitis, or vasomotor rhinitis.

The recommendation is contained in an information circular published on the Infarmed website, “New measures to minimize the risk of serious adverse effects” of drugs with pseudoephedrine, namely: Actifed, Aerinase, Aspirin Complex, Cegrinazo, Claridon, Dynaxil, Greenhals, Holsigrip. and Sinutab II.

Infarmed asks patients not to take these medications if they have severe or uncontrolled high blood pressure (untreated or treatment-resistant), severe acute kidney disease (sudden) or chronic kidney disease (long-term), or kidney failure, as these are risk factors. for the development of posterior reversible encephalopathy syndrome (PRES) and cerebral reversible vasoconstriction syndrome (CRVS).

SEPR and SVCR are rare diseases that can cause a decrease in blood supply to the brain, which can cause serious and potentially fatal complications.

The National Medicines Authority also urges patients to “immediately stop using” these medications and seek “emergency medical attention” if they develop symptoms of these syndromes, such as severe headache with sudden onset, nausea, vomiting, confusion, seizures and vision changes. .

It also recommends that health care providers advise patients to immediately stop using these medications and seek immediate treatment if they experience these symptoms.

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has accepted the recommendations of the Pharmacovigilance Risk Assessment Committee on new measures to minimize the risks of developing these syndromes.

The recommendations are based on an analysis of all available data, including post-marketing safety data, which concludes that pseudoephedrine is associated with a risk of SEPR or RCVS.

During the review, the Pharmacovigilance Risk Assessment Committee consulted with a panel of experts, patient representatives and healthcare professionals.

According to Infarmed, no fatal cases of SEPR or SVCR were reported, and most cases resolved after discontinuation of the drug and appropriate treatment.

With immediate diagnosis and treatment, symptoms of SEPR and SVCR usually disappear, says Infarmed.

“The risks of SEPR or SVCR should be considered along with other risks associated with drugs containing pseudoephedrine, including cardiovascular or ischemic events,” he emphasizes.

Also keeping in mind the importance of notifying the National Pharmacovigilance System of any suspected adverse reactions, in particular serious reactions or reactions that were not previously listed in the medicinal product information, directly through the RAM portal.