Brazil produces first national adrenaline pen for severe allergy treatments

Brazilian researchers have produced the first national adrenaline self-injectable pen, which is crucial for treating severe allergic reactions, such as anaphylactic shock. To date, as there is no Brazilian product available on the market, it is necessary to import the pens at a high cost or opt for less effective alternatives. Without import costs, developers believe that national pens could be up to 80% cheaper than imported ones.

The pen prototype was developed by a group led by the doctor and professor at the Federal University of Rio de Janeiro (UFRJ), Renato Rozental, with the support of a company in the state of São Paulo. Currently, the pen is in the initial registration phase with the National Health Surveillance Agency (Anvisa). The prototype will still undergo evaluation by the regulatory body before being launched on the healthcare market. According to Rozental, the entire process is expected to take around 11 months.

The national pen follows the specifications of products already available on the market, containing an adrenaline ampoule with a dosage adjusted to the patient's weight. The needle is also adapted for different age groups, with versions for children and adults.

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_{Researchers produce the first national self-injectable adrenaline pen (Photo: reproduction/Getty Images Embed/Demidova Ekaterina)}

In case of an allergic reaction, it's simple: just apply the contents to the side of the thigh, without the need for medical training or specific skills. Once adrenaline is injected, the reaction is quickly reversed, providing time for medical assistance and specialized care to arrive.

The professor estimates that the cost of the final product will be between R$350 and R$400, while imported pens — available in some pharmacies or purchased directly from abroad — have an average price of R$2,000.

Innovation amid years of lack of interest and lack of investment

Although the adrenaline autoinjector has existed since the 1980s, its technology is available in only 35 countries, due to the pharmaceutical industry's lack of interest in expanding production. According to Fábio Chigres Kuschnir, president of the Brazilian Association of Allergy and Immunology (Asbai), the increase in cases of anaphylaxis and new public policies have encouraged the development of the national prototype. “In the last twelve months, there has been great progress”notes Kuschnir.

An example of this is Bill 85/2024, which is being processed in the Chamber of Deputies and proposes that the pen be provided free of charge by the Unified Health System (SUS). The project has already been approved by the Health Commission and awaits analysis by the Finance, Constitution and Justice and Citizenship commissions. National production would make it easier to include this device in the public network, guaranteeing access to emergency treatment for everyone.

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_{Studies indicate that deaths related to anaphylaxis have increased in previous years (Photo: reproduction/Getty Images embed/Moyo Studio)}

Increase in cases of anaphylaxis

Anaphylactic shock is a serious allergic reaction that develops quickly and can cause breathing difficulties, tachycardia and swelling in the throat, and can even be fatal. According to Asbai, the incidence of anaphylaxis has increased among children aged 0 to 4 years, reaching levels similar to those observed in the United States.

A study carried out in 2022 by the journal Clinical Experimental Allergy indicated that in Brazil, hospitalizations and deaths related to anaphylaxis grew annually by 2.4% and 3.8%, respectively, between 2011 and 2019.

The main causes of this condition include insect bites, reactions to medications and foods, as well as increased exposure to processed foods. The introduction of a national adrenaline auto-injector, with an affordable price and easy access through the SUS, could represent a significant change in the management of these allergic emergencies in Brazil, ensuring a quick and effective response in risk situations.

Featured Photo: Brazilian researchers from UFRJ produce the first national self-injectable adrenaline pen (reproduction/Unsplash/Lucas Vasques)