The withdrawal of medicine in the country after fatal discovery

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Home » Celebrities » Gave What to Talk About » Urgent: The hasty withdrawal of popular medicine in country after fatal discovery

However, despite being popular and easily accessible, this common medicine in other parts of the world has a completely different reality.

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Places like the United States and part of the European Union have banned this medicine for decades and that is what we will talk about today.

Reasons behind the ban

Behind the veto of dipyrone in these places, there is a great controversy about a possible serious side effect of the medication: agranulocytosis.

For those who don’t know, agranulocytosis is a serious and potentially fatal change in the blood. marked by a drop in the number of some types of defense cells.

But you might be wondering: “Is there scientific evidence behind this claim?

To know the answer, you first need to know the mechanism of action of this medicine.

Dipyrone was created in the 1920s by the German pharmaceutical company Hoechst AG. Two years later, it was already available in drugstores, including in Brazil.

She became known by her commercial name Novalginawhich today belongs to the French laboratory Sanofi.

Other popular remedies that contain dipyrone are Dorflex (also from Sanofi) and the Neosaldina (from Hypera Pharma).

They are all available in pharmacies and They do not require a prescription to be purchased by consumers.

And, despite 100 years of history, the way this drug works to lower fever and relieve pain is still surrounded by some unknowns.

The biochemical pharmaceutical Laura MarisePhD in Biosciences and Biotechnology, explains that the main suspicion is that dipyrone acts against an inflammatory molecule known as COX.

Dipyrone was widely available in much of the world until the mid-1960s and 1970s, when the first studies emerged that raised awareness about the risk of agranulocytosis.

A study published in 1964 calculated that this serious blood disorder occurred in one individual for every 127 who consumed aminopyrine, whose structure is very similar to that of dipyrone.

Based on this and other evidence, the Food and Drug Administration (FDA)the United States regulatory agency, decided thatthat dipyrone should be removed from the American market in 1977.

Shortly afterwards, other countries took the same resolution, as was the case with Australia, Japan, the United Kingdom and parts of the European Union.

From the 80sbegan to emerge new evidence on medication safetywhich threw more and more controversy into the discussion.

The Boston Study, for example, was carried out in 8 countries (Israel, Germany, Italy, Hungary, Spain, Bulgaria and Sweden) and involved data from 22.2 million people.

The results found an incidence of 1.1 cases of agranulocytosis for every 1 million individuals who used dipyrone, a number considered low.

In Israel, an investigation carried out with 390,000 hospitalized individuals calculated a risk of 0.0007% of developing this change in the blood and 0.0002% of dying from this adverse event.

Already in Sweden, which only released the medicine in the 1990s14 episodes of agranulocytosis possibly related to treatment were detected.

Which represented 1 case for every 1,439 individuals who took this drug.

This higher frequency, in fact, caused the Nordic country to ban the medicine again in 1999.

Still according to the G1although there is no clear explanation, there are three factors that help to understand the scenario:

• There is a genetic mutation that appears to facilitate the appearance of agranulocytosis in some individuals who use dipyrone.
• And secondly and thirdly, higher dosages and prolonged use also influence this risk.

Situation in Brazil

In Latin America, dipyrone was the target of a large study known as Latin Study.

Between January 2002 and December 2005, scientists from Brazil, Argentina and Mexico pored over data from 548 million people.

In this universe, 52 cases of agranulocytosis were identified, which represents only a rate of 0.38 cases per million inhabitants/year.

The Latin work also showed that these episodes of serious blood disorders are relatively more common in women, children and the elderly.

Shortly before that, in 2001, ANVISA held an event called “International Dipirone Safety Assessment Panel”, in which Brazilian and foreign experts were invited.

According to a released note, taking into account the final report, its conclusions presented a consensus that the effectiveness of dipyrone as an analgesic and antipyretic is unquestionable.

Other than that, the risks attributed to its use in our population are low and similar, or lower, than those of other analgesics/antipyretics available on the market.

ANVISA also reinforced that, since the panel was held 22 years ago: “no new risks were identified or new safety alerts were issued related to dipyrone”

Because of this, there is no discussion about a possible ban on its sale in the national territory.

In addition to the country, dipyrone is also available in India, Germany, Spain, Russia, Israel, Argentina and Mexico, among others.

What do the pharmaceutical companies responsible for Dipirona say here in Brazil?

According to the BBC News Brazill. When looking for the pharmaceutical companies responsible for the most popular commercial versions of dipyrone in this country, they made the following statements:

Sanofi (Novalgina and Dorflex):

Sanofi, responsible for Novalgina and Dorflex, stated that “strictly complies with all current Brazilian legislation, especially health legislation and Anvisa regulations in force”.

“We reiterate that dipyrone has been on the world market for more than 100 years and is used by millions of patients around the world”

Hypera Pharma (Neosaldina):

A Hypera Pharmaresponsible for Neosaldinainformed that: “dipyrone is an active ingredient released by Anvisa for commercialization in Brazil”

According to her, all pharmaceutical products that contain the molecule “they have approved registration with the agency, with proof of safety and effectiveness”.

To conclude, the Brazilian Association of the Health Self-Care Products Industry (Access) stated that: “when used according to medical indications and following recommended doses, [a dipirona] is considered safe for most people.”.

“The instructions on the MIP labels must be strictly followed, the doses must be respected, avoiding excessive self-medication”

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