Introduction - Uppsala Monitoring Centre

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of prescription drugs from worldwide pharmaceutical markets – 1960–1999. Drug Inf J 2001; 35: 293–317. Gaisford W. Fatality after oxyphenbutazone in Still’s disease. BMJ 1962; 2(5318): 1517. Garrod EP. The production of bone marrow aplasia by chloramphenicol. In ‘Sensitivity Reactions to Drugs’ CIOMS Symposium, Ed. ML Rosenheim and R Moulter, Blackwell Science Publications, Oxford. Garth S. The Dispensary. A Poem. Printer John Nutt, 1699. Gauchet. Bulletin Génér De Therap. 1871; LXXXX: P 373. Gazz Int Med Chir 1954; 59: 159. Geiling EMK and Cannon PR. Pathological effects of elixir of sulfanilamide. (diethylene glycol) poisoning. JAMA 1938; 111: 919–926. George MH, Moore T, Kilburn S, Olson GR and DeAngelo AB. Carcinogenicity of chloral hydrate administered in drinking water to the male F344/N rat and male B6C3F1 mouse. Toxicol Pathol 2000; 28(4): 610–8. Gharpure K, Sharma S, Thawani V. Pharmacovigilance: Is it possible if bannable medicines are available over the counter? Indian J Pharmacol June 2005; 37(3): 191–191. Giertz H, Hahn H and Lange A. Toxicity of phenothiazines. Klin Wschr 1954; 39-40: 983–4. Giusti RM, Iwamoto K and Hatch EE. Diethylstilboestrol revisited: a review of the long term health effects. Ann Int Med 1995; 122(10): 778–88. Glasgow JFT. Reye’s Syndrome; The case for a causal link. Drug Saf. 2006; 29(12): 1111-1121. Glauser Fl, Smith WH and Caldwell A. Ethchlorvynol (Placidyl) induced pulmonary oedema. Ann Intern Med 1976: 84: 46–48. Goldberg A. Development of drug regulating authorities. Br J clin Pharmac 1986; 22: 67s–70s. Goldberg D. Carisoprodol toxicity. Mil Mede 1969; 134: 597–601. Goltdammer Several cases of collapse after 5G doses. Berl. Klin. Wochenschr 1876, p 47. Good, John Mason. The history of medicine, so far as it relates to the profession of the apothecary, From the earliest Accounts to the present Period: the evils to which the profession and the public have been of late Years equally exposed; and the means which have been devised to remedy them. Published at the request of the Committee of the General Pharmceutic Association of Great Britain. By John Mason Good, Fellow of the Medical Society of London, Member of the Corporation of Surgeons, and Author of the ``dissertation on the Diseases of Prisons and Poor houses.’’ The second edition. To which are prefixed, observations on a tract, entitled Murepsologia; And published in Answer to the former Edition. London, 1796. Eighteenth Century Collections Online. Gale. The Wellcome Trust. 24 Dec. 2009 http://0- ind.galegroup.com.libsys.wellcome.ac.uk/ecco/infomark.do?&contentSet=ECCOArticles&type=multipage&tabID=T001&prodI d=ECCO&docId=CW Goodall C. The Royal College of Physicians of London. London, 1684. Goodall EW. Hypersensitivity. Proc RSM 1912; 5(Section Epid. State med) 203–214. Gordon J. A contribution to the study of piperazine. BMJ June 16th 1894; 1291–1294. Gottlieb A, Duberstein J and Geller A. Phenformin acidosis. New Eng J Med 1962: 18: 806–9. Gottlieb R. The effect of colloidal thorium on the blood picture. Can Med Assoc J 1933; 28(5): 496-497. Gøtzsche PC. Non-steroidal anti-inflammatory drugs. BMJ 2000; 320: 1058–1061. Gould GM & Pyle WL. Anomalies and Curiosities of Medicine. Pyle Publisher: The World Wide School. November 1997 Published from: Seattle, Washington, USA. Goulding R. Wellcome Witness to Twentieth Century Medicine, vol.1, Wellcome Trust, 1997, p116. Graham JDP and Parker WA. The toxic manifestations of sodium salicylate therapy. Quart J Med 1948; 41: 153-163. Granger GA. Use of Thorotrast. BMJ 1967; ii: 112. Grant Alexander. Observations on the use of opium in diseases supposed to be owing to morbid irritability. By Alexander Grant, ... London, 1785. Based on information from English Short Title Catalogue. Eighteenth Century Collections Online. Gale Group. http://0-galenet.galegroup.com.libsys.wellcome.ac.uk/servlet/ECCO Grawitz P. Nuevas orientaciones en la terapeutica de las amebiasis. Semana Med 1935; 42: 525. Green FHK. Clinical evaluations of remedies in Britain. Lancet 27th November 1954; 1085–1091. Green FHK. Clinical evaluations of new remedies in Britain. Brit Med Bull 1944; 2: 58–60. Greenhalgh T. Drug marketing in the third world: beneath the cosmetic reforms. Lancet 1986; June 7th: 1318–1320. Greenhalgh T, Kostopoulou O and Harries C. Making decisions about benefits and harms of medicines. BMJ 2004; 329: 47– 50. Griffin JP. Venetian treacle and the foundation of medicines regulation. Br J Clin Pharm 2004; 58(3): 317–325. Griffin JP and Weber JCP. Voluntary systems of adverse reaction reporting–Part II. Adv Drug React Ac Pois Rev 1986; 1: 23– 55.
Griffin JP and D’Arcy JP. Adverse drug reactions–the information lag. In Side Effects of Drug Annual V, 1981. Grollman A. Pharmacology and Therapeutics. Lea & Febiger, Philadelphia, 1951. Grootheest Kees van. The Dawn of Pharmacovigilance. Int J Pharm Med 2003; 17 (5-6): 195-200. Gruner OC. A Treatise on the Canon of Medicine of Avicenna. Luzee & Co. London, 1930. Grünpeck, Joseph. Tractatus de Pestilentiali Scorra sive Mala de Franzos: Originem Remediaqu[ue] Eiusdem Continens. Nuremberg: Kaspar Hochfeder, 1496 or 1497. Guglielmo da Brescia, Canon 1.4 Padua, Biblioteca Universitaria, MS al numero provisorio 202, fo. 121v: ‘Item si possumus uti via securiori non debemus uti farmacia sed possumus uti via securiori ad evacuationem humorum ut bono regimine et fricationibus et resolventibus et medicinis non dando medicinas fortes.... Item si possumus uti via securiori non debemus uti periculosiori, sed via securior est flobotomia... apparet per Galenum] secunduo regiminis, dicit enim quod flobotomia est via secura evacuanda farmacia autem periculosa...,’ as quoted in Nancy Siraisi, Taddeo Alderotti: 254, note 38.) Excellentisimi (1508). Guibert V. Histoiren naturelle et médicale des nouveaux médicaments introduit dans la thérapeutique depuis 1830 jusqu’a nos jours. Librairie Médicale de H. Manceaux. 1865. Haggenstoss AH, Feldman WH and Hinshaw HC. Streptomycin in miliary tuberculosis. Am Rev Tuberc 1947; 55: 54–75. Hahnemann S. Organen der reaktionellen Heikunde [Organs of reactional therapy] Dresden: Arnold, 1810. [Organon de l’art de guérir, Dresden 1824]. Hahnemann S. Materia Medica Pura. 1825. Halls Dalle JF. Discussion on blood-letting. Proc R Soc Med 1927 April 7th; 1569. Hama R. Transmission of drug information to physicians and drug-induced suffering. In: Soda T Ed. Drug Induced Suffering, Excerpta Medica, 1980, 142–150. Hamburger F and M E. Ueber die biologisch nachweisbaren Veränderungen des menschlichen Blutes nach den Seruminjektion [On the biologically demonstrable changes to human blood after serum injection]. Wein Klinn Wschr 1903; 16:445–7. Hamilton AL (1816). Dissertatio Medica Inauguralis De Synocho Castrensi. Edinburgh: J Ballantyne. Hamilton Archibald. The effects of semen hyoscami albi. Philosophical Society of Edinburgh. Essays and observations, physical and literary. Vol.II, Edinburgh, 1756. Hamilton J. Observations on the utility and administration of purgative medicines in several diseases. Edinburgh: J Simpson. 1806. Hammer W, Holmberg G, Sjoqvist F and Wiklund PE. Drug interaction: lethal interaction between nialamide and blue-veined cheese. Lakartidningen. Dec 15 1969; 66: Suppl IV: 20. Hancher L. Regulating for competition: government, law and the pharmaceutical industry in the United Kingdom and France, PhD thesis. University of Amsterdam. Handersen HE. Gilbertus Anglicus. Medicine of the thirteenth century. The Cleveland Medical Library Association. 1918. Hardman W. ‘Ehrlich-Hata’ or ‘606’. BMJ 1911; 1: 54–55. Harris Thomas, surgeon. A treatise on the force and energy of crude mercury. ... By Thomas Harris, ... London, 1734. Based on information from English Short Title Catalogue. Eighteenth Century Collections Online. Gale Group. http://0- galenet.galegroup.com.libsys.wellcome.ac.uk/servlet/ECCO Harrow BR, and Sloane JA. Acute renal failure following oral cholecystography, a unique nephrographic effect. Am J Med Sci 1965; 249: 26. Haselkorn T, Whittemore AS, Udaltsova N and Friedman GD. Short-term choral hydrate administration and cancer in humans. Drug Saf 2006; 29(1): 67–77. Hauben M and Aronson JK. Defining ‘signal’ and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf 2009(2); 2: 99–110. Hayes AW. Principles and Methods of Toxicology. CRC Press. 2001. Haygarth J. Of the Imagination, as a Cause and as a Case of Disorders of the Body; Exemplified by Fictitious Tractors and Epidemical Convulsions. Bath: Crutwell, 1801. Heberden W. Antitheriaka, an essay on Mithridatium and Theriaca. Medical Tracts 1745. Hedenmalm K and Spiget O. Agranulocytosis and other blood dyscrasia associated with dipyrone (metamizole). Eur J Clin Pharmacol 2002; 58: 265–274. Heilman DH, Heilman FR, Hinshaw HL, Nichols DR and Herrell WE. Streptomycin: absorbtion, diffusion, excretion and toxicity. Am J Med Sci1945; 1: 554–559. Heinlein. Urticaria in Folge der Darreichung von salicylsaurem Natron [Consequences of administration of sodium salicylate]. Aerztl. Intelligenzblatt April 1878. Herbst AL, Scully RE. Adenocarcinoma of the vagina in adolescence. A report of seven cases including 6 clear cell carcinomas (so-called mesnephromas) Cancer 1970; 25(4): 745-57.
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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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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
Page 356 and 357: In 1958 Garrod reported an approxim
Page 358 and 359: purpura, toxic hepatitis, and aplas
Page 360 and 361: area and degree of inflammation. 19
Page 362 and 363: 1952 Iproniazid (Marsilid) Was intr
Page 364 and 365: SED 1960: addiction frequently obse
Page 366 and 367: cutaneous sarcoidosis, erythema mul
Page 368 and 369: 1957 Ethchlorvynol (Placidyl, Seren
Page 370 and 371: Official warnings were sent out in
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 382 and 383: and nialamide; biguanides, e.g. buf
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 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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