Introduction - Uppsala Monitoring Centre

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emarked that it was a violent medicine. Parkinson commended it in 1640. However, this was not the first account of the benefits of digitalis (see 1765). Withering wrote on the 1 st July 1785 whilst Dr Simmons of the Westminster General Dispensatory wrote in the London Medical Journal, Volume 2, on the 11 th March 1785 ‘An account of the effects of Digitalis Purpura in dropsy’ ‘Without its seeming to be of much efficacy Digitalis purpura ranks among poisonous plants, and may, if indiscreetly administered produce alarming and even fatal effects’, but went on to say his patient passed 9 pints of urine. A letter from a Dr John Warren in reply said a trial of the virtues of this medicine about six years ago in a patient with anasarca 148 , ascites and hydrothorax produced in 36 hours nearly seven gallons of urine and was perfectly cured, but had a great deal of nausea and frequent attempts to vomit. Observations on the use of opium in removing symptoms supposed to be owing to morbid irritability (1785) by Alexander Grant, Senior surgeon of His Majesty’s Military Hospitals during the late war in North America (1779). He used opium in cases of syphilis where mercury was not working. ‘a tremor, which sometimes came on never obliged me to decrease the dose unless the bowels were disposed to be costive…. Except sometimes a giddiness… pulse decreased to between forty and fifty strokes per minute…. On the second or third day with some headache… with some diarrhoea. Increased secretion of saliva is not uncommon as well as urine.’ (Grant, 1785). First documented medical use of the word ‘placebo’ which means ‘A common place method or medicine’ in the ‘New Medical Dictionary, and general repository of physick containing an explanation of the terms and a description of the various particulars.’ 2 nd edition. (Motherby, 1785). 1786 An experimental inquiry into the properties of opium, and its effects on living subjects: with observations on its history, preparations and uses. Being the disputation which gained the Harveian Prize for ... 1785 by John Leigh, Edinburgh: C. Elliot, 1786. ‘I prevailed on a healthy man to take 15 drops of it in a short space of time and it began to operate and brought on such a vomiting as deterred me from making further experiments of this nature.’ He tried opium in his own eye and it gave him very severe pain lasting for 5 minutes. 148 Anasarca = generalised massive oedema
Experiment XXV He gave a 30 year old man 2 grains (130 mgm) in alcohol–‘headache, vertigo, drowsiness, unusual heat about his stomach’…In the same man 3 grains (194 mgm).. ‘too much whiskey, warming stomach and heart, loss of appetite, weakness and languor’… same man 4 grains ‘violent sickness of the stomach, confusion in the head, fainted, frightful dreams, increased urine, insatiable thirst…’. Experiment XXIX 30 year old man–5 grains (324 mgm): ‘sickness, vertigo, headache, drunkenness, great thirst.’ The same dose in a 25-year-old woman gave violent convulsions. This dose titration in a volunteer is unusual.
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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
Page 102 and 103: Dose filthy; and much more after a
Page 104 and 105: Dichotomy In all people there is so
Page 106 and 107: it Venom, Venom! Poison, say they (
Page 108 and 109: or the dominions beyond thereof.’
Page 110 and 111: Quinsy = tonsillitis Spotted fever
Page 112 and 113: 1652 Culpeper, Nicholas, (1616-1654
Page 114 and 115: Figure 7. The Expert Doctor’s Dis
Page 116 and 117: themselves with brawling and alterc
Page 118 and 119: principles of the art of physick’
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 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 168 and 169: 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
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eported in Australia as early as th
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1907 Synthesis of arsphenamine (Sal
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The bill was strongly opposed by th
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James McDonagh, referring to Salava
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erythema, spasmodic coryza, an atta
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their confidence. Certainly the med
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1935 First use of prontosil red (su
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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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