THE EMA’s decision to rule out banning Nolotil has been blasted by patient advocate and campaigner Cristina del Campo.
She has called the decision ‘unbelievable’ and implied that the ruling has ‘financial motives’.
Cristina told the Olive Press: “As far as I’m concerned, what they’re saying is that the benefits to the pharmaceutical company outweigh the risks to patients.
“They have admitted that it is an unpredictable drug which can cause death at any point of treatment, regardless of the dose and even if you have taken it before without issue. Yet still, they say the benefits outweigh the risks.”
For many years, Cristina has compiled hundreds of deaths of British expats and tourists – and other northern Europeans – linked to the drug.
Now, she is seeking tougher controls and compensation for family members of those who died after taking it.
The Olive Press has also launched many campaigns and frequently reported on the issue to raise awareness of Nolotil.
“The victims are outraged. As their advocate, I do not accept this decision and will continue to fight,” she said.
Her supporters also expressed their shock at the decision.
“The power of big pharma! It smacks of the oxycontin scandal in the States,” one said.
While another commented: “It’s an absolutely atrocious outcome. Makes me wonder about visiting Spain in future.”
Others called for the drug to be banned altogether: “Total disgrace! You are fighting a just cause and it should be banned asap!”
Nolotil, and other products containing metamizole, are thought to cause adverse effects for patients of northern european descent, including British people.
However, current research has not allowed health authorities to rule out or confirm the possibility of higher risk populations.
It comes after the European Medicines Agency (EMA) revealed on Friday it would not be banning or putting restrictions on the drug.
Instead, they will update product information to highlight the risk of agranulocytosis, a known side effect of Nolotil.
“Agranulocytosis involves a sudden and sharp decrease in granulocytes, a type of white blood cell, that can lead to serious or even fatal infections,” they said.
“The committee recommended that healthcare professionals must inform patients to stop taking these medicines and seek immediate medical attention if they develop symptoms of agranulocytosis.”
The recommendation comes after a review by the EMA and PRAC, prompted by concerns from Finnish authorities.
Now, the PRAC’s evaluation must be ratified by the Coordination Group (CMDh) of the EMA, which includes all the European medicines agencies.
I have taken nolotil for years.No problems. Typical stupid ex pat making trouble. Spain is ful of fat unhealthy expat Brits. I wish they would all go back to the nanny homeland.