Spain’s Agency of Medicines and Medical Devices (AEMPS) has updated its guidelines for the drug Nolotil warning against it being prescribed to those visiting Spain for a short time.
“The drug should only be prescribed for short-term treatments, seven days at the most and should be avoided long term if it is not possible to monitor the patients' white cell count with regular blood tests,” said the statement from AEMPS.
The warning also advised “special precaution with patients of advanced age” because they were more vulnerable to infection.
The warning effectively means a ban on prescribing the drugs to visitors and came about following a campaign by Cristina Garcia del Campo, a medical translator in Alicante, who lobbied for an inquiry after she discovered the link between a number of British and Irish tourists who suffered blood poisoning when prescribed the drug.
“I feel very happy about the recommendations issued by the AEMPS,” Garcia del Campo told The Local. “If these recommendations are strictly followed by doctors and chemists, I will be satisfied, otherwise, I will continue to work until they are,or the problem is solved, whatever it takes.”
An investigation by the drug regulator confirmed that at least ten people prescribed Nolotil while visiting Spain had died from blood poisoning after contracting agranulosis (also known as granulopenia) – an acute condition caused by a severe lowering of the white blood cell count.
The drug has not been licensed for use in the USA, Britain and Sweden but is widely prescribed in Spain.
The drug's prospectus claims that agranulocytosis is a “very rare” side effect that could occur in one in 10,000 patients, the AEMPS found that maybe more frequent among Britons due to a possible “genetic peculiarity”.
Boehringer Ingelheim, the manufacturer of Nolotil, said the drug is available in many generic forms in Spain and other European countries and there is no scientific evidence that specific populations are prone to develop side effects.