New warning over painkiller Nolotil

Europe orders changes to drug information

THE European Commission has ordered changes to information issued over the use of medicines containing the controversial analgesic metamizole “due to its possible adverse effects”.

Medical journal Redaccion Medica reported the EC decided to “modify” the prospectus of medicines containing the “active principle” – in Spain, it said “the most used analgesic, Nolotil, has this active ingredient.”

Metamizole is a generic name for the painkiller; a number of brand names are available in Spain, across Europe and internationally – however, the commission noted that it was banned in some European countries and the United States of America.

And the Spanish journal reported that the European Union had indicated: “metamizole has been associated with agranulocytosis and anaphylactic shock”.

The EC was said to have decided to change the information regarding the use of the drug because of discrepancies across member states over when metamizole should be given to pregnant and breastfeeding women because of the perceived risks to baby.

It explained there was “lack of uniformity” in the information offered in different countries – and noted: “Although drugs containing metamizole were withdrawn in several European countries and also in the United Sates because of the risk of agranulocytosis, in other countries such as Spain, Poland and Germany, metamizole is frequently used.”

CAMPAIGN

Campaigner Cristina Garcia del Campo is leading a fight for a total ban on the drug in Spain and believes it has caused more than 40 deaths and left other people with life changing complications.

It has been found to trigger agranulocytosis – a sudden and drop in disease fighting white blood cells – leading to the risk of dangerous sepsis and septic shock.

Last year, Cristina convinced medical chiefs in Madrid to issue doctors with new guidelines – ordering it should not be given to tourists and only be used on the resident population as a ‘prescription only’ drug and to patients who could be closely monitored.

There was an acknowledged increased risk to British people and Scandinavians but she believes complications across the Spanish population have been under-reported – with any complications linked to a patient’s condition rather than their treatment.

The medical campaigner’s battle continues, she said in Spain the drug was “handed out like sweets” and added: “I don’t think people will be really safe until it is banned.”

Cristina continues to compile statistics – with a growing number of Spanish nationals reporting problems - and hopes people will share experiences to help her research.

She can be contacted by email at cristinadrugresearch@gmail.com or via her Facebook page which contains more information about metamizole.