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 ban 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.
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.