Introduction - Uppsala Monitoring Centre

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Weakness 873, 1763, 1652, x x x Headache 1776 x x x x Body aches/pains 1776 x Dizziness 1751 x x x x Giddiness Ataxia/ staggering 1763,1751, 1781 x x x Vertigo 873, 1776, 1780 x x Tachypnea 873 x x Confusion 1756 x x Convulsions 370 BC, 1756, 1776, 1789 x x x x x x Paralysis 1776 x x x x x
Disturbed sleep 1597, 1619, 1756, 1763, 1776 Respiratory depression 873 x x x Coma x x x x Death 370 BC, 777, 1595, 1619, 1733, 1789 x x x x Allergic symptoms = pulmonary oedema and, oedema of glottis and uvula Although the first mention of the use of henbane was in 3500 BC it is not until the 18 th century that most adverse events, other than mental problems, were reported. Again there was a gap of 700 years with only two reports of toxicity 873 to 1595. Prior to 1790 there is no mention of dry mouth, Loss of memory, hallucinations, increased pulse, irritability, dysarthria, urine retention, diuresis, rash, sweating, headache, tachypnea, confusion, paralysis, respiratory depression or coma. Those in italics are those that could be explained by scientific terms not in use then. In the King’s American dispensatory 1898 it says ‘On account of not producing headache, it is preferred to opium’, although it goes on to say that henbane can cause it. This may mean that it is rare. The aphorism ‘hot as a hare, blind as a bat, dry as a bone, red as a beet, mad as a hen’ (Morton, 1939) and originally applied to atropine also applies to hyoscyamus (bold in the table). Yet ‘dry mouth’ is not mentioned until 1898. The many mentions of disturbed sleep before contrasts with the period afterwards where there is no mention. There is a steadily increasing awareness of all the ADRs with the passing years and by 1898 we have a full picture. Again it is difficult to pair off the graphic descriptions of symptoms of bygone years with our more precise terminology, e.g.
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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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principles of the art of physick’
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Poisons upon Animals, etc.’ Made
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First medical journal ‘Medicina C
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Closed in 1725 (Warren, http://www.
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for each drug especially for helleb
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hurry of the spirits, causes rest a
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3. 1736 Frederich Hoffmann wrote th
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Francois Chicanneau. This contains
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can only be obtained by a just acqu
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Pills about him, left Gilbert Jones
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George Key wrote ‘A dissertation
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sometimes excites convulsions.’ H
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drugs’ said of henbane: ‘The bl
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ut it would not become generally us
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hiccoughs*; convulsions; syncopes,
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avec leurs antidotes; rédigée d
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1780). 1781 ‘Observations on the
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emarked that it was a violent medic
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Figure 8 Arsenic © Wellcome Images
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oppression of the breast, fever, he
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of former authors on these points i
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Vernor and Hood, London, 1798. ‘I
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Vaccines pharmacovigilance data. Wh
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that I can find where the phrase
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Physician/scientist Drug taken ADRs
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Physician/scientist Drug taken ADRs
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Chapter 7. 19 th Century A lchemy h
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White Hellebore: ‘violent purging
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medicine as potentized development
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vomiting, increase discharge of uri
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How many patients have they lost? H
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diarrhoea…If plentifully prescrib
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1841 Sir Astley Cooper gave the eff
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The UK House of Commons Select Comm
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Kolbe and Lautemann made synthetic
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predisposition that one cannot call
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this it may be noted that the major
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emulsion. To the strained emulsion,
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eruptions. The first study of a dru
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‘It presents several advantages o
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as the charlatans continued to flou
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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
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
Page 218 and 219: These postulates governed toxicolog
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Page 222 and 223: and treatment. It deals with methyl
Page 224 and 225: USA, because less than 1% of new co
Page 226 and 227: 1981). Dr Kelsey said at an open pu
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Page 230 and 231: must be due to some recently introd
Page 232 and 233: This of course will add to more rap
Page 234 and 235: 1878) The latter being urticaria. 1
Page 236 and 237: Poison the cow-pox, that the dispos
Page 238 and 239: Persistence of drugs As explained a
Page 240 and 241: have and have not had an exposure t
Page 242 and 243: types of reactions: Lewin’s ‘Th
Page 244 and 245: knowledge of medicine and science.
Page 246 and 247: scurvy in 12 patients, i.e. two pat
Page 248 and 249: Mouth and throat tingling/burning o
Page 250 and 251: s Sneezing (nasal use) 1586A,1657,
Page 252 and 253: types of hellebore. There was a gap
Page 254 and 255: 1546, 1565, 1752, 1789 Troubles in
Page 258 and 259: ‘maketh man mad and foolish’ co
Page 260 and 261: Mixtures: Donovan’s solution (Liq
Page 262 and 263: Swollen tongue Ulceration of gums 1
Page 264 and 265: Polyneuropathy enemy of the nerves
Page 266 and 267: Headache 1711, 1733 1736, 1752 1788
Page 268 and 269: 1806 Cough 1590, 1804 1806 x Conjun
Page 270 and 271: The loss of hair has only been repo
Page 272 and 273: the responsible organism, Treponema
Page 274 and 275: Loss of memory 1586, 1619,1763 x Im
Page 276 and 277: Antidiuretic effect 1776 urine inse
Page 278 and 279: Nausea/vomiting # 1876 2,81,19 , 18
Page 280 and 281: alkalosis * 1949 26 Hypoglycaemia 1
Page 282 and 283: Drowsiness 1881 28 , 1884 86 , 1909
Page 284 and 285: Papilloedema 1965 37 , 1965 37 Myop
Page 286 and 287: Pancytopenia 1966 32 VI 1968 F D Me
Page 288 and 289: SED = Meyler’s Side Effects of Dr
Page 290 and 291: 29. Williams JO, Mengel CE, Sulliva
Page 292 and 293: Aspirin. 57. Al-Abbasi AH. Salicyla
Page 294 and 295: 282. Headache, giddiness, tinnitus,
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Page 298 and 299: dose Aspirin produces generally its
Page 300 and 301: Douthwaite and Lintott first showed
Page 302 and 303: Chapter 14. Streptomycin treptomyci
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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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