Introduction - Uppsala Monitoring Centre

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Physician/scientist Drug taken ADRs reported 1884 Ferra Y Clua Jaine Cholera vaccine 1886 II Bardakh Rabies vaccine No reaction 1897 Arthur Eichengrun Aspirin No ill effects 1899 FC Floeckinger Acetyl salicylic acid Headache, tinnitus, flashes of light, increased pulse rate and sweats 1903 Franke Aspirin Swallowing difficulties, strangulation, face red, tachycardia of 160 beats per minute, urticaria and sweating to it 1902 CF Pirquet Diphtheria, and scarlet fever and tetanus vaccine Swollen and painful arm with fever 1914 GR Mines IV Muscarine Died due to poisoning 1921 FG Banting 10 units Insulin No effect 1927 HL Blumgart Radon No effect 1930 Chauncey Leake Furan (wood tar derivative) 1933 John A Kolmer Live attenuated Polio vaccine 1934 Albert Schweitzer Yellow fever vaccine (sub/cut) Headache and pain on micturition No effect No effect 1936 LS Goodman Prostigmine Difficult breathing, giddiness, weaving movements, fear of death and shock. Required atropine 1943 Albert Hofman Lysergic acid diethylamide (LSD) Teonanacatl, Psilocybin Restlessness, dizziness, anxiety, dilated pupils and stimulated imagination 1944 Scott Smith & Frederick Prescott D’tubocurarine (Seostim) Temporarily paralysed 1951 Otto K Hayrhofer Succinyl choline chloride Muscle weakness, double vision, ptosis, muscle twitching and paralysis of respiratory muscles
Physician/scientist Drug taken ADRs reported 1951 G Pauletta Chloramphenicol succinate Chloramphenicol glutarate No effect Anaphylactic shock and died 195? JG Hamilton Isotopes of Na, Cl, Br, I and Plutonium Developed leukaemia The main source for this table was ‘Self-experiments: sources for study’ by Arsen P Fiks, edited by P A Buelow. Westport, Conn. London: Praeger, 2003. This book contains many other self-experimenters. Some details also from Altman, 1986. Summary We now have publication of case series and detailed individual case histories. The use of numbers becomes more common (Tröhler , 2011) and there are now fuller details of ADRs with doses. Experimentation now plays a part in the study of medicines. Hoffman’s response to an epidemic of ergotism is to establish the cause with experiments in animals and this leads to regulatory action. Leigh performs a series of experiments on volunteers to explain the effects of opium. There are more references to figures, e.g. pulse rates, doses and numbers of patients. Whereas we had previously individual reports of ADRs we now have publications devoted to ADRs in general from Halle University throughout the century and from Doeveren in 1779. Following Helmont’s proposed comparison of two treatments in 1662 comparisons between treatments were made in the following century, e.g. 1722, 1760,and 1766. We have now the whole gamut of pharmacovigilance techniques save for pharmacoepidemiology.
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The Dawn of Drug Safety Myles D B S
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George Mann Publications Contents
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§ References .....................
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Mrs L Lake SRN, SCM for help with t
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and international bodies play a maj
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Mechanism of action Causality Predi
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possible blindness, paralysis of th
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Filipendula ulmaria or Spiraea ulma
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2. Laws and Regulations. a. Prevent
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Algeria, dated 7000-5000 BC, there
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Sennacharib 11 (705-681 BC), which
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(henbane), opium and colchicum. (Ma
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mandragora, mentha, myrrh, opium, p
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16. Hellebore (alias Christmas Rose
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clothes and head-bindings, and thei
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ecovered after a dose of a drug.’
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the Christian era it was well known
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given at such a time, it is sure to
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he strewed powdered Henbane, and li
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The second category of herbs was ca
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1 st quarter of the 2 nd century AD
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The Dark Ages from the 5th to the 8
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ecomes disordered, his tongue swell
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inspected at any time without warni
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done on any “new” product: 1. T
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drugs. It represents the first gove
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not written in the form of tables.
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idea of four humours: blood (sangui
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ordered pharmacists to prepare drug
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No mention of side effects. 1270 A
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population was approximately 6 mill
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ed as blood, red wine, Then would h
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time of his death in 1534 in three
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1497 Syphilis broke out for the fir
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1686 Stockholm ‘Pharmacopoeja Hol
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drugs, from the shores of the Red S
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medical tracts from Avicenna, Razie
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all manner of creatures of God crea
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powders of myrrh, of mastic, of cer
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swollen in the interior, that first
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mercury is the special best remedy
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78 Uncomes = whitlows will use it i
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nightshade; but not without great e
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may be chosen the best and most luc
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‘A New Herball: Wherein are conta
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such an enmity with blood of man.
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The surprise visitation was carried
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nature of it, unto this may be adde
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sometimes they so trouble the brain
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as you will use, and boil it 6. or
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Dose filthy; and much more after a
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Dichotomy In all people there is so
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it Venom, Venom! Poison, say they (
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or the dominions beyond thereof.’
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Quinsy = tonsillitis Spotted fever
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1652 Culpeper, Nicholas, (1616-1654
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Figure 7. The Expert Doctor’s Dis
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themselves with brawling and alterc
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Page 120 and 121: Poisons upon Animals, etc.’ Made
Page 122 and 123: First medical journal ‘Medicina C
Page 124 and 125: Closed in 1725 (Warren, http://www.
Page 126 and 127: for each drug especially for helleb
Page 128 and 129: hurry of the spirits, causes rest a
Page 130 and 131: 3. 1736 Frederich Hoffmann wrote th
Page 132 and 133: Francois Chicanneau. This contains
Page 134 and 135: can only be obtained by a just acqu
Page 136 and 137: Pills about him, left Gilbert Jones
Page 138 and 139: George Key wrote ‘A dissertation
Page 140 and 141: sometimes excites convulsions.’ H
Page 142 and 143: drugs’ said of henbane: ‘The bl
Page 144 and 145: ut it would not become generally us
Page 146 and 147: hiccoughs*; convulsions; syncopes,
Page 148 and 149: avec leurs antidotes; rédigée d
Page 150 and 151: 1780). 1781 ‘Observations on the
Page 152 and 153: emarked that it was a violent medic
Page 154 and 155: Figure 8 Arsenic © Wellcome Images
Page 156 and 157: oppression of the breast, fever, he
Page 158 and 159: of former authors on these points i
Page 160 and 161: Vernor and Hood, London, 1798. ‘I
Page 162 and 163: Vaccines pharmacovigilance data. Wh
Page 164 and 165: that I can find where the phrase
Page 166 and 167: Physician/scientist Drug taken ADRs
Page 170 and 171: Chapter 7. 19 th Century A lchemy h
Page 172 and 173: White Hellebore: ‘violent purging
Page 174 and 175: medicine as potentized development
Page 176 and 177: vomiting, increase discharge of uri
Page 178 and 179: How many patients have they lost? H
Page 180 and 181: diarrhoea…If plentifully prescrib
Page 182 and 183: 1841 Sir Astley Cooper gave the eff
Page 184 and 185: The UK House of Commons Select Comm
Page 186 and 187: Kolbe and Lautemann made synthetic
Page 188 and 189: predisposition that one cannot call
Page 190 and 191: this it may be noted that the major
Page 192 and 193: emulsion. To the strained emulsion,
Page 194 and 195: eruptions. The first study of a dru
Page 196 and 197: ‘It presents several advantages o
Page 198 and 199: as the charlatans continued to flou
Page 200 and 201: digoxin. It was not until the explo
Page 202 and 203: eported in Australia as early as th
Page 204 and 205: 1907 Synthesis of arsphenamine (Sal
Page 206 and 207: The bill was strongly opposed by th
Page 208 and 209: James McDonagh, referring to Salava
Page 210 and 211: erythema, spasmodic coryza, an atta
Page 212 and 213: their confidence. Certainly the med
Page 214 and 215: 1935 First use of prontosil red (su
Page 216 and 217: groups admitted patients on alterna
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These postulates governed toxicolog
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some of the herbs: hellebore, hemlo
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and treatment. It deals with methyl
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USA, because less than 1% of new co
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1981). Dr Kelsey said at an open pu
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Germany, particularly for use in ch
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must be due to some recently introd
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This of course will add to more rap
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1878) The latter being urticaria. 1
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Poison the cow-pox, that the dispos
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Persistence of drugs As explained a
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have and have not had an exposure t
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types of reactions: Lewin’s ‘Th
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knowledge of medicine and science.
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scurvy in 12 patients, i.e. two pat
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Mouth and throat tingling/burning o
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s Sneezing (nasal use) 1586A,1657,
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types of hellebore. There was a gap
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1546, 1565, 1752, 1789 Troubles in
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Weakness 873, 1763, 1652, x x x Hea
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‘maketh man mad and foolish’ co
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Mixtures: Donovan’s solution (Liq
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Swollen tongue Ulceration of gums 1
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Polyneuropathy enemy of the nerves
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Headache 1711, 1733 1736, 1752 1788
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1806 Cough 1590, 1804 1806 x Conjun
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The loss of hair has only been repo
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the responsible organism, Treponema
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Loss of memory 1586, 1619,1763 x Im
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Antidiuretic effect 1776 urine inse
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Nausea/vomiting # 1876 2,81,19 , 18
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alkalosis * 1949 26 Hypoglycaemia 1
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Drowsiness 1881 28 , 1884 86 , 1909
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Papilloedema 1965 37 , 1965 37 Myop
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Pancytopenia 1966 32 VI 1968 F D Me
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SED = Meyler’s Side Effects of Dr
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29. Williams JO, Mengel CE, Sulliva
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Aspirin. 57. Al-Abbasi AH. Salicyla
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282. Headache, giddiness, tinnitus,
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ullous eruption < 1 % and purpura.
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dose Aspirin produces generally its
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Douthwaite and Lintott first showed
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Chapter 14. Streptomycin treptomyci
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1946 September 28 th 1946 November
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1947 Forty patients. Dose 3.0 gm da
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cheeks, & the blood kept coming up
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‘By far the most important toxic
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In their study 1.6% of patients dis
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Renal dysfunction Vision- Yellow Di
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(Crofton, 2009). Asthma, pancytopen
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Ideal knowledge of an ADR How much
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Table 13. Number of first reports o
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Despite these actions the prescribe
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Remedy, the active ingredient was D
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on the lips (Thorwald, 1962) Uses:
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Comment: the side effects were seve
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SED 1952: habituation causes sympto
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and acuity, dementia, inability to
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have expected that it would have be
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the poor economic status of these a
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SED 1952: no mention. A warning was
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Withdrawn: over-the-counter sales w
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(ADEC, 1971). It is unlikely that c
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dose for six months, mice also deve
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symptoms.’ (Willcox, 1934). SED 1
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Comment: a Lancet editorial entitle
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1933 Dinitrophenol (2,4-dinitrophen
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1995). SED 1952: the same side effe
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Delay in recognition: None Delay in
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In 1958 Garrod reported an approxim
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purpura, toxic hepatitis, and aplas
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area and degree of inflammation. 19
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1952 Iproniazid (Marsilid) Was intr
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SED 1960: addiction frequently obse
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cutaneous sarcoidosis, erythema mul
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1957 Ethchlorvynol (Placidyl, Seren
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Official warnings were sent out in
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Delay in recognition: ≤ one year
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Withdrawn: USA 1962 Availability: n
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new original reports. Table 16. Num
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eporting (Griffin & Weber, 1986), b
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John Abraham and Helen Lawton Smith
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and nialamide; biguanides, e.g. buf
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see Hart PW in ‘Blood dyscrasias
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used in 1779 with reference to toba
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perhaps even stranger that there we
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of benefit to me.’ The first rule
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government authority including perf
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4) There was less risk of having an
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adverse effects more willingly. Now
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to restrict or withdraw a drug. ‘
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Armer RE and Morris ID. Trends in e
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Brookes R. (Richard). An introducti
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www.ordre.pharmacien.fr/upload/Synt
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of prescription drugs from worldwid
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Herbst Al, Vilfelder H and Posakanz
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Kereković M and Curković M. Olfac
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Med 2008;101: 148-155. Louis PCA. R
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MRC. At National Archives: FD1/6769
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Reynolds TB, Lapin AC, Peters RL an
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Solecki RS. Shanidar IV, a Neandert
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Vépan. Gaz Medic. De Strassb. 1865
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Introduction - Uppsala Monitoring Centre

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