Introduction - Uppsala Monitoring Centre

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Physician/scientist Drug taken ADRs reported 1765 Samuel Bard Opium Slowing of the pulse 1793 Samuel Crumpe Opium Headache, nausea, drowsiness, tremors, and vertigo 1799 Humphrey Davy Nitrous oxide Giddiness, muscle relaxation and tendency to laugh 1800 SF Hermbstadt Arsenic (4 G) Abdominal pain, trembling extremities and cyanosis 1803 Morphia Face flushed, nausea, dizzy and stomach pain 1810 Samuel Hahnemann Many See his textbooks 1821 Enoch Hale Castor oil injections Oily taste, abdominal cramps, headache, and nausea and vomiting 1825 Johann Jorg 17 drugs–hydrocyanic acid (dilute) Valerian, Opium, Digitalis, Tincture of Iodine St Ignatius bean 1835 Jan Evangelista Purkinje Ipecac (emetine) Belladonna Turpentine Camphor Digitalis ? Without any discernable action Light-headedness, inebriation and deep sleep ? ? Headaches, abdominal pain and diarrhoea Nausea, salivation, cramps and diarrhoea; blurred vision, dry mouth and tachycardia; hypnotic effects, euphoria, and stupor; totally unconscious; flickering vision, bradycardia and
Physician/scientist Drug taken ADRs reported Strammonium skipped beats Opium Henbane Calomel 1844 Horace Wells Nitrous Oxide No painful sensations 1846 WTG Morton Ether Numbness of limbs, like a nightmare and then unconscious for 7-8 minutes 1847 Sir JY Simpson Chloroform Became unconscious 1848 Erik Jacobson Disulfuram (Antabuse) After alcohol–headache, difficulty breathing, vomiting and lowered BP 1849 Thomas Nunneley Acetyl Chloride Anaesthetic 1851 Joseph Toynbee Chloroform Died 1855 Cesare Bertagnini Salicylic acid Tinnitus and dizziness 1855 Sir Robert Christison Physostigmine (Calabar bean) Giddiness, numbness of the limbs, torpidity and faintness Oxalic acid, Coniine, Opium, Cannabis, Lead, Strychnine, Arsenic 1856 John Snow Amylene Anaesthesia 1858 AG Field Nitroglycerine Nausea, tinnitus, jaw dropped and fullness in the neck 1863 TR Fraser Eserine eye drops Contracted pupils 1873 Otto H F Obermaier Cholera vaccine injection 1879 Sir Arthur Conan Doyle Gelsenium (tincture) Nitroglycerin Died after a few days Giddiness, severe depression, headache and diarrhoea Congestive headache 1880 William S Halsted Cocaine Lack of fatigue, but became addicted
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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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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 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 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
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
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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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Introduction - Uppsala Monitoring Centre

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