Introduction - Uppsala Monitoring Centre

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and nialamide; biguanides, e.g. buformin and phenformin. 15. Chronicity of ADR: e.g. Phenacetin where the study started in 1968 and the result published in 1991 (Dubach et al., 1991); 38 years after the hypothesis was first mooted. 16. Under reporting of ADRs: prior to 1960 there were no centres for the reception of suspected ADRs? 17. Even the most advanced countries, from the regulatory point of view, were hampered by insufficient regulations, inadequate science, absence of databases and few experts. ‘Before 1938 it would be difficult to say that drug development had any plan or requirements at all, although certainly some effective agents emerged and some facts about them were discovered. But there were few of the drugs we now consider effective and there were real disasters.’ (Temple, 1996). 18. Variation in the incidence of the ADR due to poorly known factors, e.g. analgesic nephropathy was greater in Glasgow perhaps because most of the factories making Phenacetin were sited there. Similarly in Belgium, most cases were found in the county of Antwerp where the factories were sited. The incidence varied considerably from country to country: Australia 20%, Belgium 18.4%, Switzerland 17.5%, USA 7-10%, Germany 5%, Scandinavia 3.4%, Canada 2.5% France 1.6%, UK 1.2% Italy 1.0% (Vanherweghem & Even–Adin, 1982). 19. Although only one ADR might be named as the reason for withdrawal of a drug from the market the regulatory authorities would also have been influenced by the other ADRs attributed to the drug. 20. Date when the drug was introduced. Over the time span of this book there have been many changes in the attitude of patients and regulators towards the adverse effects of drugs. It is only post 1960 that research into why drugs are withdrawn from the market has been undertaken. Information concerning the reasons(s) why a drug has been removed from a specific market are difficult to obtain, e.g. Health Canada did not maintain a comprehensive list of drugs that had been removed from Canada because of safety concerns, nor did it have a database that would allow the construction of such a list. For sixteen out of the 41 products removed from the Canadian market between 1963 and 2004 there was no definite information about why they were removed from the Canadian market, although they were withdrawn in either the UK or the US (or both) because of safety concerns (Lexchin, 2005).
Grouping of drugs withdrawn Metals: antimony, mercury (+ mercurothiolate), bismuth, arsenic, tin and copper Addictive drugs: chloral, phenobarbitone, glutethimide, ethchlorvynol, datura and sodium arsenate Analgesics/anti-inflammatory drugs: Aspirin, amidopyrine, Phenacetin, metamizole, phenylbutazone and cincophen Laxatives: phenolphthalein, oxyphenisatin and dantron Hypnotics: pyrithyldione, thalidomide and chloral hydrate Antihistamines: methapyrilene, oxomemazine and thenalidine Anti–diabetic drugs: phenformin and buformin Monoamine oxidases: iproniazid and nialamide Antibiotics/antibacterials: chloramphenicol, tetracycline, clioquinol, sulfathiazole, sulfamethoxydiazine, sulfamethoxypyridazine and di-hydro-streptomycin Others: thorium, diethylstilboestrol, piperazine, diamthazole, chloroform, triparanol and urethane. Chemical classification Inorganic drugs: mercury, antimony, bismuth and arsenate sodium. These were first used between 3000 BC (arsenic) and 1753 AD (bismuth). The use of metals ran parallel to the use of herbs and was boosted by Paracelsus. Aliphatic organic drugs: urethane, chloroform, chloral hydrate, carisoprodol, urethane, Stalinon, pyrithyldione, buformin and ethchlorvynol. There is a strange anomaly in that ether was first mentioned in 1275 and again in 1546 when it was made by equal parts of thrice rectified spirit of wine (ethanol) and oil of vitriol (sulphuric acid) in contact for two months and then it was distilled. How was it that there was a gap of over 500 years before the next synthesis was made? These drugs are organic drugs lacking a benzene ring and the first (urea) was synthesised in 1923. Chloral hydrate was synthesized in1832. Aromatic organic drugs: Phenacetin, piperazine, amidopyrine, clioquinol, Aspirin, phenobarbitone, dipyrone, dinitrophenol, promethazine, diethylstilboestrol, sulfathiazole, sulphamethoxypyridazine, dihydrostreptomycin, chloramphenicol, phenylbutazone, tetracycline paediatric, iproniazid, thenalidine, glutethimide, oxyphenbutazone, cincophen, phenolphthalein, oxyphenisatin, thenalidine, triparanol, methapyrilene, danthron, thiomersal, bunamiodyl, cupric bis-quinolone sulphate, diamthazole and phenformin. These drugs all contain a benzene ring. Benzene was first isolated in 1836. Grouping by type of ADR Agranulocytosis/Aplastic anaemia: amidopyrine, dipyrone, cincophen, pyrithyldione, sulfathiazole, chloramphenicol, phenylbutazone, thenalidine, sulfamethoxydiazine, sulfamethoxypyridazine and urethane. For further references,
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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
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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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Page 338 and 339: SED 1952: no mention. A warning was
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Page 344 and 345: dose for six months, mice also deve
Page 346 and 347: symptoms.’ (Willcox, 1934). SED 1
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Page 352 and 353: 1995). SED 1952: the same side effe
Page 354 and 355: Delay in recognition: None Delay in
Page 356 and 357: In 1958 Garrod reported an approxim
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Page 362 and 363: 1952 Iproniazid (Marsilid) Was intr
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Page 368 and 369: 1957 Ethchlorvynol (Placidyl, Seren
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Page 372 and 373: Delay in recognition: ≤ one year
Page 374 and 375: Withdrawn: USA 1962 Availability: n
Page 376 and 377: new original reports. Table 16. Num
Page 378 and 379: eporting (Griffin & Weber, 1986), b
Page 380 and 381: John Abraham and Helen Lawton Smith
Page 384 and 385: see Hart PW in ‘Blood dyscrasias
Page 386 and 387: used in 1779 with reference to toba
Page 388 and 389: perhaps even stranger that there we
Page 390 and 391: of benefit to me.’ The first rule
Page 392 and 393: government authority including perf
Page 394 and 395: 4) There was less risk of having an
Page 396 and 397: adverse effects more willingly. Now
Page 398 and 399: to restrict or withdraw a drug. ‘
Page 400 and 401: Armer RE and Morris ID. Trends in e
Page 402 and 403: Brookes R. (Richard). An introducti
Page 404 and 405: www.ordre.pharmacien.fr/upload/Synt
Page 406 and 407: of prescription drugs from worldwid
Page 408 and 409: Herbst Al, Vilfelder H and Posakanz
Page 410 and 411: Kereković M and Curković M. Olfac
Page 412 and 413: Med 2008;101: 148-155. Louis PCA. R
Page 414 and 415: MRC. At National Archives: FD1/6769
Page 416 and 417: Reynolds TB, Lapin AC, Peters RL an
Page 418 and 419: Solecki RS. Shanidar IV, a Neandert
Page 420 and 421: Vépan. Gaz Medic. De Strassb. 1865
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Introduction - Uppsala Monitoring Centre

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