Introduction - Uppsala Monitoring Centre

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the responsible organism, Treponema pallidum, was made by Fritz Schaudinn and Eric Hoffman. Cure involved the conversion of a positive Wasserman to a negative response. In view of the high spontaneous cure rate the efficacy of mercury could only have been found by a controlled clinical trial against placebo and monitored by following the Wassermann conversion rates. Many would have considered this to be unethical as equipoise would not have been present. Arsphenamine had appeared in 1910 and was believed to be the answer to syphilis, but no controlled clinical trials were performed comparing it with mercury. Hyman in 1941 evaluated the routine conservative treatment of syphilis, which included mercury, bismuth and arsenic. He concluded: Paragraph 5: The ‘spontaneous’ course of early syphilis tends to “cure” in approximately 43 per cent of all patients, and an additional 22 per cent will remain clinically well with positive serology. Thus, two patients in three, afflicted with early syphilis, may be expected to live their lives and eventually succumb without clinical manifestation of the infection. Paragraph 17: The great triumph of specific chemotherapy in syphilis seems sharply limited to those patients with early syphilis (constituting perhaps 16 per cent of Wassermann-positive individuals) who have persisted through continuous and continued forms of therapy (5% of those who initiate therapy) (Hyman, 1941). I can find no evidence that there were any clinical trials comparing mercury with Arsphenamine, again because of lack of equipoise; Arsphenamine was believed to be very superior to mercury treatments. I conclude that mercury may have been better than placebo, if given correctly for a long period, but only if given early in primary syphilis and then only in a few patients. Fernel comments in 1579 that all the late symptoms of syphilis were really due to mercurial poisoning (Abraham, 1948) were probably an exaggeration and the converse might have been true. Dr Swediaur said ‘To distinguish complaints arising from mercury from real venereal ones great judgement is required.’ (Swediaur, 1788). Mercury was used for other diseases, e.g. skin diseases, and examination of the adverse events reported in these circumstances might clarify the situation as to which ADRs could be attributable to mercury, but unfortunately there are not many studies. A study of mercury ointment in psoriasis in 24 patients over 6 weeks showed no symptoms of toxicity despite 13 patients having toxic mercury levels (Inman et al., 1956). The ADRs reported in books and articles on toxicology might be thought to be relevant, but on the whole these tend to be those symptoms produced by vapour from mercury used in industry (Buckell et al., 1946) or from suicide attempts where the patients have taken corrosive sublimate (HgCl 2 ) in such large doses that the initial symptoms progress rapidly to renal failure. These reports of suicide cases might not contain the more subtle symptoms (Johnstone, 1931). Mercury caused tremendous suffering over 450 years without the recompense of
curing the disease and was thereby the greatest drug disaster yet known. Chapter 12. Opium ndications: pain, aided digestion, jaundice, acute fever, palpitations, loss of teeth, I cough, liver and intestines, malaria, eye disease, syphilis, strengthening the teeth and gums, and mental illness (Lev & Amar, 2008). Table 7. Adverse reactions to Opium Nausea 1763,1776, 1793 x x x x 70% Vomiting 1763, 1786, 1788, 1793 Anorexia Constipation 1712, 1764, 1776, 1785, 1789 x x x x 7% x x x x 5-10% Diarrhoea (Higher dose–10-12 Gr) Stertorous breathing 1763, 1785, 1788 5-10% 130 BC, 1306 strangleth., 1776, 1793, x x x x x Dyspnoea 47AD, 1763, 1776 5-10% Respiratory depression Euphoria 1652, 1763, 1789 x x x x x Dysphoria 47BC, 1586, 1652, 1763, 1786 x x x x
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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
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
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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
Page 236 and 237: Poison the cow-pox, that the dispos
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 250 and 251: s Sneezing (nasal use) 1586A,1657,
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
Page 258 and 259: ‘maketh man mad and foolish’ co
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 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,
Page 296 and 297: ullous eruption < 1 % and purpura.
Page 298 and 299: dose Aspirin produces generally its
Page 300 and 301: Douthwaite and Lintott first showed
Page 302 and 303: Chapter 14. Streptomycin treptomyci
Page 304 and 305: 1946 September 28 th 1946 November
Page 306 and 307: 1947 Forty patients. Dose 3.0 gm da
Page 308 and 309: cheeks, & the blood kept coming up
Page 310 and 311: ‘By far the most important toxic
Page 312 and 313: In their study 1.6% of patients dis
Page 314 and 315: Renal dysfunction Vision- Yellow Di
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Page 318 and 319: Ideal knowledge of an ADR How much
Page 320 and 321: 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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