Introduction - Uppsala Monitoring Centre

egional lymphadenopathy, malaise, myalgia, and headache
The rare serious ADRs are Guillain-Barré syndrome, erythema multiforme,
anaphylaxis, urticaria, encephalopathy and convulsions. The immense rarity of
serious ADRs is shown: encephalitis with smallpox vaccination 2.9 per million and
for vaccinia necrosum 155 0.9 per million(Cono et al., 2003), but these are adverse
events and without a suitable control group the ADRs cannot be accurately
calculated.
Terminology
The oldest written sources are from the Hippocratic era and were therefore written in
Greek. The Arabs translated hundreds of the Greek texts from 800–1000 AD and
then added their own knowledge and this was imported back to Italy via Salerno and
Toledo in the 12th century. In the first century AD when the Roman empire became
powerful the Latin language took over and the Greek texts were translated into
Latin. The dominance of Latin in medical literature persisted in England until the end
of the 17th century, but continued in Europe into the mid 19th century. Thereafter
the national medical language was usually used, but with French, German and
English being used for international communication (Wulff, 2004). Probably because
of the USA becoming the most powerful country in the world English or American
has now become the dominant language for medical communications.
Originally there was no set phrase to refer to what we now call ‘Adverse Drug
Reactions’ (ADR), but the word poison or poisonous was used to describe drugs
with adverse effects. Richard Brookes (see above), in 1754, uses the terms
‘poisonous effects’ and ‘bad effects’. In 1789 Wouter van Doeveren gave a lecture
at Leiden, with the title ‘Sermo academicus de Remedio Morbo, sive de malis, quae
hominibus a remedies, sanandi causa adhibitis, saepe numero accidere solent’
[Remedio morbo, drug diseases or ailments which often affect people as a result of
remedies administered to them for therapeutic purposes] (Grootheest, 2003). An
ADR was not usually seen as an entity so they used a pejorative adjective plus a
noun such as ‘effect’, e.g. ‘pernicious effects’ or ‘noxious effects’. Lewin in the 1883
translation of his book ‘Die Nebenwirkungen der Arzei mittel’ [Untoward effects of
Drugs] said: the greatest variety of names may be found in medical literature for
these untoward symptoms following the exhibition of drugs. In Germany they have
been and still are known as ‘nebenwirkuingen’, ‘ physiologische nebenwirkungen or
arzneisymptome’ and are also spoken of as the ‘special’ or ‘accidental’ or ‘peculiar’
action of the drug. French authors refer to them as ‘inconvenénients’ or
‘inconvénients thérapeutique’ or ‘accidents’, ‘cas d’accidents’ or ‘effets secondaires’.
In England they were occasionally termed ‘unpleasant symptoms’. The first mention
155 Vaccinia necrosum is a progressive necrosis at the vaccination site, mainly occurring in immunodeficient
patients, with a fatality rate of about 90%