Are you taking amitriptyline? Invima warns of serious reactions to this antidepressant: patients should be alert to these possible symptoms.

The National Institute for Food and Drug Surveillance (Invima) issued an alert warning about the risk of serious adverse skin reactions associated with the use of amitriptyline , a tricyclic antidepressant that works by blocking the reuptake of norepinephrine and serotonin at nerve endings.

According to the organization, this medication increases synaptic concentrations of norepinephrine and serotonin , which would explain its positive effect in the treatment of depression. Patients who use it usually notice improvement between the fourth and sixth week after starting therapy.

However, there have been reports of people experiencing symptoms after taking this drug.

If you are taking amitriptyline and experience any of the following symptoms, Invima recommends stopping use of the medication and seeking medical attention immediately:

The agency reminded everyone that amitriptyline is a prescription drug , and therefore warned: "Under no circumstances should you self-medicate or take it on the recommendation of family or friends."

In a statement issued on September 10, Invima reported that since November 2024, serious adverse skin reactions associated with the use of amitriptyline have been reported, including drug reaction syndrome with eosinophilia and systemic symptoms (Dress).

According to the Pharmacovigilance Risk Assessment Committee (PRAC) Assessment Report, based on the periodic safety reports (PSR) for this medicine, these reactions can be life-threatening.

Following the analysis carried out by the Pharmacovigilance Group, the following conclusions were drawn:

In October 2024, the European Medicines Agency (EMA) published a report warning of the emergence of cases of Dress syndrome, a rare but serious adverse reaction linked to the use of a specific medication.

According to the organization, the review of scientific reports showed a clear temporal relationship between drug use and the reaction , as well as a favorable response to both discontinuation of treatment and re-exposure.

The statement was later echoed by the Spanish Agency for Medicines and Health Products (AEMPS) and, more recently, by the National Directorate of Pharmacy and Drugs of Panama.

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