The Association of People Affected by Drugs (ADAF) denounces Health for the serious damage that Nolotil is causing

2023-09-15 11:00:45

The drug Nolotil (metamizole) is forbidden in many countries while it is the best seller in Spain. And the Association of People Affected by Drugs (ADAF), which has more than 350 people affected by Nolotil (metamizole), has denounced the Ministry of Health and the Spanish Agency for Medicines and Health Products (AEMPS) for their inactivity in the face of the damage that is being done. causing that popular treatment.

The drug is associated with life-threatening blood disorders such as agranulocitosis (sudden fall of the immune system due to lack of granulocytes that can cause death). For this reason, the marketing of metamizole is prohibited in many countries, such as Japan, Australia, the United Kingdom, France and the United States.

However, still authorized in Spain despite the fact that the health authorities know their risks, and do nothing to prevent them.

As explained Cristina García del Campo, president of ADAF, we have no record of a reported case study since 2018! In addition, the medication, the AEMPS knows, is being prescribed as a first-line drug, without analyzing clinical records and without monitoring, and without testing other similar drugs, as the technical specifications and the leaflet say should be done.”

More than a year ago, the AEMPS officially indicated to the Spanish Ombudsman that it has an epidemiological study underway on this matter. However, today, there is no news about this study. The severity and incidence of this risk is being minimized.

The AEMPS has been aware of this matter for a long time and that is why the Almodóvar & Jara buffetwho attends ADAF, has denounced Health for infringement of fundamental rights.

“We have consulted numerous drug control and supervision institutions (USA, UK, Australia, etc.) and they all agree in their answers. This medication has a very unfavorable benefit/risk profile. In these countries the risk profile is the highest on the scale of 1 to 10, with 10 being the highest risk score for this medication,” says García del Campo.

Neither the Technical Sheet nor the prospectus are updated. They are biased documents and also include different information; They warn about the risk and greater susceptibility. The AEMPS has never recognized that the incidence of agranulocytosis risk is higher in these populations.

The producers and marketing authorizations do not urge change either, thus contravening their pharmacovigilance and information functions. Furthermore, neither the AEMPS, nor the laboratories, nor the medical and pharmaceutical societies, promote studies on the matter because, it seems, no one is interested.

We believe that it is not necessary to remember (it is a topic well known by all medical professionals) that the metamizole continues to be dispensed without a prescriptionis prescribed for non-accepted indications, for a time and in doses higher than those recommended, without taking into account the greater susceptibility of some people to suffer from agranulocytosis and without making any analytical or clinical control in prolonged treatments.

Cristina García del Campo, who discovered the damage caused by Nolotil.

For all this, the Association of People Affected by Drugs asks:

-BAN THE DRUG AS A PRECAUTION IN CITIZENS OF COUNTRIES WHERE IT HAS BEEN PROHIBITED: Australia in 1965, Norway, the United States in 1977, Denmark in 1979, Saudi Arabia in 1980, Malaysia in 1987 and Pakistan in 1988. United Kingdom. Australia with maximum risk level (10), etc.

-PROMOTE A META-ANALYSIS TAKING INTO ACCOUNT RISK FACTORS AND MEASURE PROBABILITIES OF agranulocytosis as a confirmed side effect of metamizole.

-Information to marketing owners about their pharmacovigilance plans in relation to the notifications they have received of suspected serious adverse reactions.

-TO THE AEMPS AN INDIVIDUALIZED STUDY OF THE CAUSAL NEXUS OF PHARMACOVIGILANCE FOR THE CASES NOTIFIED BY THE PRESIDENT OF adaf.

-The modification of the technical sheet and prospectus. update of information. caution or warning of danger for the British, Irish and Anglo-Saxon population (USA, UK, AUSTRALIA) AND, IN GENERAL, FOR PEOPLE FROM COUNTRIES WHERE THE MARKETING OF THE DRUG IS NOT ALLOWED.

For more information: Cristina García del Campo, President of the Association of People Affected by Drugs (ADAF). Telephone: [phone].

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