“Fever, chills, sore throat and painful changes in the mucous membranes, especially in the mouth, nose and throat, or in the genital or anal area.” These are some of the early symptoms that suggest the appearance of agranulocytosis after the consumption of metamizole, the analgesic marketed in Spain under the Nolotil trademark, according to the manufacturing companies in Spain. a letter addressed this week to health professionals.
In communication, distributed and supervised by the European Medicines Agency (EMA) and the Spanish Agency for Medicines and Health Products (AEMPS), the companies that market medications with metamizole remind physicians of “the need to remain alert to these symptoms, since agranulocytosis can appear at any time during treatment, and even shortly after its completion.”
No worrying news
The letter sent to the health workers does not contain “any worrying news”, according to sources from the AEMPS. elDiario.esbut offers new details to guarantee the proper use of the medication and prevent possible cases of agranulocytosis from going unnoticed.
Although the letter itself recalls that a recent EMA report concluded that the benefits of metamizole outweigh the risks, the substance has long been under the spotlight due to cases in which this decrease in granulocytes, cells of the immune system that occur, occurs. They help us defend ourselves against infectious agents, which in the most serious cases can be fatal. The suspicion that metamizole can trigger this problem is the reason why it is not sold in France, the United Kingdom and Scandinavian countries such as Sweden, Norway or Denmark.
Masked symptoms
In the communication issued this Monday, the companies remind doctors of the need to stop treatment and seek immediate medical attention if they experience any of these symptoms and warn that if metamizole is taken for fever, some of these signs may go unnoticed. “Similarly, symptoms may be masked if patients are receiving antibiotic treatment,” they warn.
“If signs and symptoms suggest agranulocytosis, a complete blood count (including differential differential) should be performed immediately, and treatment should be discontinued while awaiting results,” the letter warns. “If agranulocytosis is confirmed, treatment should not be restarted.”
The companies that distribute metamizole remind that, after a review at European level, the contraindications, warnings and precautions on the use of medicines containing metamizole, both for patients and healthcare professionals, are reviewed to minimize the serious outcomes of the known risk of agranulocytosis.
“The updated information will be incorporated into the technical specifications (information for health professionals) and the package insert (information for citizens) of medicines containing metamizole to reflect the measures to minimize the severity of the outcomes associated with the risk of agranulocytosis,” they add. .
The AEMPS recalls that safety letters addressed to healthcare professionals are individualized communications that pharmaceutical companies send directly to healthcare professionals to communicate important new safety information. These letters are sent to health professionals either by email or through scientific societies and their content is reviewed and agreed upon in advance with the AEMPS.
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