Introduction - Uppsala Monitoring Centre

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Mechanism of action Causality Predisposing factors Treatment and its effect Reversibility or sequelae. Using these criteria we shall see how little we know about the ‘well known’ reactions to our six marker drugs. To illustrate the process of pharmacovigilance over the centuries six ‘marker’ drugs have been followed in this book: 1. Hellebore Figure 3 Hellebore There are two types of hellebore: Helleborus (buttercup family) with 20
species and Veratrum (lily family, Liliaceae), with 45 species. (i) Black Hellebore (Helleborus niger, Christmas Rose, Helleborus officinalis) Dating from 585 BC and in frequent use as a purgative but with serious type A reactions. It contains the glycosides: helleborin, C 36 H 42 0 6 a potent narcotic, helleborein, C 3 H 44 0 15 , helleboresin, C 3 0H 38 0 4 , and helleboretin, C 14 H 20 0 3 , hellebrin, C 36 H 52 O 15 , a digitalic narcotic. Used for purging and as an abortifacient and emmenagogue. Its action is due to enhanced sodium ion conductivity, which activates the Bezold-Jarish reflex 4 causing slowing of the heart rate and lowering of the blood pressure. The high amounts of ranunculin or protoanemonin in the leaves, stems and flowers of H. niger are responsible for dermatitis, which can follow exposure to bruised root material, leaves, stems and flowers. The cardiac glycosides present are responsible for toxic digitalis-like effects: bradycardia, prolonged P-R interval, idioventricular rhythm, bundle-branch block, ventricular fibrillation, slow, irregular pulse and asystole. These are thought to be more with the other species of the hellebores rather than with H. niger. (ii) Any of various plants of the genus Veratrum, especially V. viride of North America, having large leaves and greenish flowers and yielding a toxic alkaloid used medicinally. The name was given to a number of toxic plants, whose precise identification still causes confusion. (a) White Hellebore, now known as Veratrum album The plant is highly toxic, containing veratrine, protoveratrine A and B, and the teratogen cyclopamine and jervine. Used as an emetic Veratrum is irritating and ingestion can result in a burning sensation in the upper abdominal area followed by salivation, vomiting, purging, sneezing, gastric erosion, hypotension, and bradycardia. There have been several poisonings reported in humans with the different species. Although the plant is highly toxic, it is believed to be the ‘hellebore’ used by Hippocrates as a purgative. Reveratrol was isolated in 1940 from the roots of white hellebore. (b) Green hellebore or Veratrum viride or American hellebore. Not too dissimilar from Veratrum album, but with slightly different constituents. It causes sneezing, watery eyes, excess saliva, vomiting, diarrhoea, a burning sensation in the mouth and throat, and inability to swallow. These symptoms are followed by a tingling sensation, dizziness, 4 Bezold-Jarish reflex = when the cardiac sensory receptors are stimulated by stretch or drugs there is increased parasympathetic activity and inhibition of sympathetic activity promoting reflex bradycardia, vasodilatation and hypotension and at the same time modulating renin release and vasopressor secretion(Mark,1983).
Page 2 and 3: The Dawn of Drug Safety Myles D B S
Page 4 and 5: George Mann Publications Contents
Page 6 and 7: § References .....................
Page 8 and 9: Mrs L Lake SRN, SCM for help with t
Page 10 and 11: and international bodies play a maj
Page 14 and 15: possible blindness, paralysis of th
Page 16 and 17: Filipendula ulmaria or Spiraea ulma
Page 18 and 19: 2. Laws and Regulations. a. Prevent
Page 20 and 21: Algeria, dated 7000-5000 BC, there
Page 22 and 23: Sennacharib 11 (705-681 BC), which
Page 24 and 25: (henbane), opium and colchicum. (Ma
Page 26 and 27: mandragora, mentha, myrrh, opium, p
Page 28 and 29: 16. Hellebore (alias Christmas Rose
Page 30 and 31: clothes and head-bindings, and thei
Page 32 and 33: ecovered after a dose of a drug.’
Page 34 and 35: the Christian era it was well known
Page 36 and 37: given at such a time, it is sure to
Page 38 and 39: he strewed powdered Henbane, and li
Page 40 and 41: The second category of herbs was ca
Page 42 and 43: 1 st quarter of the 2 nd century AD
Page 44 and 45: The Dark Ages from the 5th to the 8
Page 46 and 47: ecomes disordered, his tongue swell
Page 48 and 49: inspected at any time without warni
Page 50 and 51: done on any “new” product: 1. T
Page 52 and 53: drugs. It represents the first gove
Page 54 and 55: not written in the form of tables.
Page 56 and 57: idea of four humours: blood (sangui
Page 58 and 59: ordered pharmacists to prepare drug
Page 60 and 61: No mention of side effects. 1270 A
Page 62 and 63:
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
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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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