Introduction - Uppsala Monitoring Centre

cases were subsequently reported throughout the world. In the U.S.A. three
epidemiologic studies were done in the late 1970’s and early 1980’s, which
showed a statistical association between Reye’s syndrome and the use of
Aspirin for treatment of febrile illnesses in children. In the early 1980’s
warnings were issued to the public and physicians about the possible
association between the use of Aspirin and Reye’s syndrome. Heated
controversies developed concerning the validity of the studies between
physicians, public advocates, U.S. Public Health Service, pharmaceutical
manufacturers and others. Aspirin use was voluntarily severely curtailed and
the incidence of Reye’s syndrome fell dramatically. In the peak year of 1980
there were 555 cases reported in the U.S.A., by 1987 only 36 and in the late
1990’s only two to three per year. However there is still debate as to its causal
factors; Firstly, many cases were the result of misdiagnosis and secondly,
there were flaws in the methodology and antiemetics have also been
suggested as a factor. It has been written that Aspirin is definitely not the
cause of Reye’s syndrome (Orlowski et al., 2002) The fact that the syndrome
almost disappeared after the warnings were given although suggestive might
also be accounted for by another factor, such as an epidemic of a viral
disease. The same reasoning applies to acrodynia (see 1903) and deaths
associated with isoprenaline inhalers. That there is an association between
Aspirin and Reye’s syndrome is indisputable, but whether it a causal
relationship has been disputed (see pages 315-316) (Glasgow, 2006;
Orlowski et al., 2002) The Aspirin Foundation (supported by Aspirin
manufacturers) concludes; there is a lack of convincing evidence that Aspirin
causes Reye syndrome: it may be one of many possible factors but many
cases currently reported are probably due to inborn errors of metabolism.
I) Acute Salicylate poisoning (Type A events): headache, dizziness, nausea &
vomiting, deafness, tinnitus, vertigo, visual disturbance, sweating, thirst,
hyperventilation, dehydration, abnormal acid base balance, hyperpyrexia,
depressed consciousness, convulsions, hyper & hypoglycaemia, pulmonary
oedema, acute tubular necrosis, tremor, weakness, ataxia, dysarthria,
parathesia, diplopia, hallucinations, papilloedema, confusion, agitation (Greer
et al., 1965). Albuminuria, haematuria and heart failure (Balazs, 1930). It is
rare below 40mgm per 100cc (Grollman, 1951).
Bayer Pamphlet (28 pages) dated probably early 1901.
Includes (translated from the French):
Dosage: 3 grammes per day taken as 50 centigrammes every four hours. The
innocuity of Aspirin is absolute: no action on the stomach or the digestive tract… the
gastric tolerance is absolute… It is almost always useless to give more than 3 gr.
Not because there is any fear of a side effect whatever, but simply because at that