Introduction - Uppsala Monitoring Centre

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s Sneezing (nasal use) 1586A,1657, 1752, H A A AV Watery eyes H (Inflammation) A V Dimness of vision 1845A, (blindness), H V A AV V V Dilated pupils 1845A, H V AVN Spasms of ocular muscles 1568, H, eyes start out of head A V Difficult in swallowing, dry mouth. 873 A, H A V V Somnolence 78 AD V V Headache H V V Skin eruption or itching 1789, H, Redness of face A (local use) N (local use) Skin pricking (local use) A Cold sweat 1789,1845N, H AVN V Elek V Tinnitus H N Fever 1752, 1789, A V
Death 370 BC, 1568, 1651, 1662, 1667, 1798. N A AVN V Hahnemann (1825) quotes in his 2 nd edition for Veratrum album from 26 different historical sources and there are 716 symptoms written in the vernacular from 5 provers, which makes their interpretation difficult (Hahnemann, 1825). He doesn’t mention stupor, fever or death, but does add more than 6 reports of cough and chilliness (?fever). There were 4 reports of dilated pupils and 4 for contracted pupils, other than these and reports concerning the pulse (no measurements of rate) there was nothing to indicate that a physical examination had occurred. SE of Drugs 1952 = Meyler’s ‘Side Effects of Drugs’ 1st edition 1952 also mentions renal damage, pulmonary oedema and cerebral oedema. Elek = Separate paper by Elek et al in 1953, placed here for convenience. Album only: tremor, gastric erosion, collapse, skin pricking and restlessness Niger only: diuresis and tinnitus Viride only: headache and somnolence Hellebore is no longer mentioned in the British Pharmacopoeia, but it was in the US pharmacopoeia of 1898. In 1889 it was said to be no longer used, as it was obsolete, but still used in domestic animals. The active alkaloids in Veratrum viride or American hellebore were isolated in 1943 and by 1946 and became a product named ‘Vertavis’ and was used in clinical practice for hypertension. The adverse effects of these alkaloids were: fall in blood pressure with collapse, bradycardia, nausea and vomiting, tightness in the chest, excess salivation, parathesia about the mouth, joints, hands and feet, and transient blurring of vision (Holley & Koffler, 1950). It was still use in 1962 in hypertension. It is also still available (Micromedex, 2008) in the USA as part of a mixture containing Veratrum viride, hyoscyamus and phenobarbitone or combined with Rauwolfia. It is difficult to date its demise from general use, but it was probably due to the change in medical philosophy in that it was no longer believed that purging patients or making them vomit was helpful. It wasn’t until after hellebore went out of fashion that the means to discover the mechanisms for the ADRs were discovered. The early reports are often general comments and not specific: dangerous 370 BC, 1491, 1619; fatal 370 BC, 1491; poison 49 BC, 47 BC; too violent 1586; perilous 1657; unhappy remedy 23 BC; not to be taken by old men, weaklings, etc. 78 AD, and frequently the early reports do not differentiate between the various
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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
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
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
Page 228 and 229: Germany, particularly for use in ch
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
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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 252 and 253: types of hellebore. There was a gap
Page 254 and 255: 1546, 1565, 1752, 1789 Troubles in
Page 256 and 257: Weakness 873, 1763, 1652, x x x Hea
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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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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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