Hospitalizations for severe allergic reactions have more than doubled in 10 years, but the device remains off the national market
Cases of anaphylaxis have increased by more than 100% in Brazil in 10 years, according to data from Asbai (Brazilian Association of Allergy and Immunology). In 2024, 1,143 episodes were recorded in the country, an increase of 107% compared to 2015. Anaphylaxis is a systemic reaction that can cause a drop in blood pressure, shortness of breath and even death from cardiovascular collapse.
“Allergies in general are on the rise around the world. Changes in lifestyle and climate change are some of the factors that explain this increase, but better publicity and knowledge about the severity of anaphylaxis may also be behind the greater number of hospitalizations”says pediatrician Fátima Rodrigues Fernandes, president of Asbai.
However, if hospitalizations for this serious condition have been growing at a rapid pace in the country, one of the main resources to combat this threat remains unavailable here: self-injectable adrenaline pens. Abroad, these products are sold under names such as EpiPen, Jext and Anapen, and are considered by allergists to be the gold standard for emergency care.
Epinephrine —a hormone better known as adrenaline— is used as a response to acute crises caused mainly by food triggers, medications or insect bites. It opens the airways and stops the exaggerated action of the immune system that started the allergic crisis. “The adrenaline pen is not only necessary, it is indispensable. It is what will prevent death from a serious reaction and allow the patient to be treated”declares allergist Bárbara Britto, from the immunology team at Einstein Hospital Israelita.
In Brazil, interested parties must request importation, often in court, and pay approximately R$3,000 for the medicine. For those who do not have this possibility, the only way to receive adrenaline is through treatment in hospital emergencies, where the substance is administered with syringes and ampoules.
In some special cases, it is possible to take these medications home with authorization, but with all the difficulty of administering them in the correct dose in emergencies, this authorization is rare. “Without pens, patients are left unprotected, at risk of death from a possible reaction”says Fernandes.
The problem is that this method of administering the epinephrine pen was not registered with Anvisa (National Health Surveillance Agency), which prevents its commercialization in Brazil. “Access depends on specific imports and problems in pricing rules that could affect the sale of the device also keep pharmaceutical companies away”says the president of Asbai.
In a note sent to Einstein AgencyAnvisa confirms that a product recognition request process was never registered. It says that the body “can only authorize a registration after a request from a company interested in producing or importing the medicine, which has not occurred to date”.
The urgency of a portable “life preserver”
When faced with anaphylaxis, adrenaline is the only medication capable of reversing the symptoms. The dose administered by the pen is safe and should be used as soon as the first signs of a reaction appear in severe conditions.
Side effects are mild and appear more when there is accidental use. “The dose of the autoinjector is small, designed to avoid serious side effects. The most common is having tremors or mild tachycardia. The risk of not using it is much greater”declares Britto.
Adults generally need to carry two pens, to repeat the dose after a few minutes, if necessary. The application is intramuscular and must be done in the thigh region, due to the size of the needle. “It hurts a lot”says Einstein’s doctor. “But we always give patients instructions on how to use it correctly, as the applicators also change the way the pen works, which changes some details depending on the brand. It’s easy to use, but as those who need it tend to be serious cases, it’s important to be very safe when using it”.
Efforts to nationalize
In 2024, a group of Brazilian researchers led by doctor Renato Rozental, professor at UFRJ (Federal University of Rio de Janeiro), announced during the Brazilian Congress of Allergy and Immunology the development of a prototype of the 1st national self-injectable adrenaline pen. Despite the good news, it does not have an industrial scale to apply for registration with Anvisa.
For Asbai, however, it is urgent to regulate a device like this to allow its use in the SUS (Unified Health System). “The ideal would be to have this pen in schools, restaurants, event venues, airplanes. The presence of the autoinjector in public spaces could reduce deaths from anaphylaxis”says Fátima Fernandes.
There are also bills being processed in Congress to speed up the production and distribution of pens to Brazilians at proven risk of a serious allergic reaction. Court decisions have also favored patients.
In São Paulo, the MPF (Federal Public Ministry) was supported by the Court in a decision taken on October 23 so that the public health network in Ribeirão Preto (SP) and 23 municipalities on the outskirts of the city begin distributing self-injectable epinephrine to patients who already have a medical prescription to receive it.
“The device saves lives and should be accessible like any essential medication”says the president of Asbai. For allergists and their patients, every minute without a pen represents a preventable risk of complications.
With information from
