Introduction - Uppsala Monitoring Centre

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Ideal knowledge of an ADR How much do we know about the most common reactions for the first five marker drugs compared with a modern drug–Streptomycin (Type A reaction characteristics in italics that will alter with dose): The manifestation (clinical or laboratory) both subjective and objective. Graded both for severity and seriousness Frequency or incidence, both absolute and relative to similar drugs with confidence intervals. Mechanism of action. Causality Predisposing factors. Treatment and its effect Reversibility or sequelae. Next we will look at the dates of the first reports of the adverse events for the four ancient marker drugs: hellebore, henbane, and mercury and opium. The dates of the first reports on the adverse events with a marker drug tell us how quickly the new AEs were discovered and reported. Table 12 covers the four ancient drugs and shows that after an active Greek and Roman period there was a relative dark age for drug safety in the Western world from the 2 nd century until the 16 th century, whilst there was an active Arabic period in the 9 th century. The birth of printing followed by the introduction of medical journals seem to have spurred another active period in the West from the 16 th to the 20 th century. The relative inactivity thereafter probably reflects the disuse of these drugs as the active principles of henbane and opium took over from the raw herbs and the uselessness of hellebore was realised in the late 19 th century and better drugs supplanted mercury. The peak for mercury in the 16 th century was caused by the syphilis epidemic in combination with the newly started printing presses. The 18 th century was the start of the period of medical experimentation when reporting new adverse events reached its peak. Hahnemann’s provings after 1810 produced a plethora of possible adverse reactions for hellebore, but apart from this there was a decline in new reports during this century. These data are very soft as they depend on the depth of my research, the availability of original reports, and the relative inaccessibility of reports in foreign languages.
Table 12. Number of first reports of adverse events with the four ancient marker drugs 3 10 1 Greek Period 2 1 2 1 Roman Period 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - 5 4 4 - Arabic Period - - - - - - - - - - - - - - - 1 - - - 2 - - - 2 Birth of printing 1440 2 2 4 20 Syphilis epidemic 3 1 5 3 Start of Medical Journals 1665 - 1682 5 23 18 19 Period of experimentation 12 H=8 5 6 1 H = Hahnemann provings - 1 2 2 - 2 4 - The two more modern drugs show a different pattern. Aspirin shows that after the initial reports that there was a relative lull during the 1910s and 1920s followed by a more active period, only for reports to fall off again in the 1970s. The advent of paracetamol in 1956 and ibuprofen in 1962 caused a diminution in Aspirin sales, but it picked up again after its anti-coagulant properties were found in the 1960s. The new uses of Aspirin have enlarged the market yet again. The fall off of reports after 1960 probably means that all its adverse effects were then known.
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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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Page 272 and 273: the responsible organism, Treponema
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,
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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
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Page 320 and 321: Table 13. Number of first reports o
Page 322 and 323: Despite these actions the prescribe
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Page 326 and 327: on the lips (Thorwald, 1962) Uses:
Page 328 and 329: Comment: the side effects were seve
Page 330 and 331: 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 342 and 343: (ADEC, 1971). It is unlikely that c
Page 344 and 345: dose for six months, mice also deve
Page 346 and 347: symptoms.’ (Willcox, 1934). SED 1
Page 348 and 349: Comment: a Lancet editorial entitle
Page 350 and 351: 1933 Dinitrophenol (2,4-dinitrophen
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
Page 364 and 365: SED 1960: addiction frequently obse
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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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