Introduction - Uppsala Monitoring Centre

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Renal dysfunction Vision– Yellow Disturbed vision x x x x x x x x x x x x x x x x x Hypotension x x x x x Skin eruption SJ syndrome /TEN Toxic erythem a x x x x x x x x 191982 x Urticaria x x x x x Pruritus x x x x x x Oral lesions x x Anosmia Jaundice x x Psychosis x x x x x CNS Facial parathesia Peripheral neuritis Encephalopathy Neuromuscular block x x x x x x x x x x 191971 x 191952 x x x x x x x x x x Histamine release = Headache, flushing and fall in blood pressure Injection site reaction = pain, soreness, induration and lipodystrophy Intrathecal injection reactions = headache, nausea and vomiting, nystagmus, slow respiration, retention of urine, delirium, loss of weight and meningeal irritation Deafness = deafness and tinnitus Vestibular effects = Vertigo, dizziness, giddiness, ataxia and cochlear toxicity Neuromuscular blockade = impaired vision, respiratory paralysis (1961) and muscular weakness (1965) Skin eruptions = urticaria, angioneurotic oedema, purpura, erythroderma; roseola, follicular, maculopapular, scarlatiniform, morbilliform and bullous exanthemas
Facial parathesia = usually circumoral Oral lesions = stomatitis, erosions, ulcers and leucokeratosis Disturbed vision = included ambylopia, diminished accommodation, diplopia and optic neuritis (Walker, 1961) Renal dysfunction = raised blood urea nitrogen Myocarditis = Fiedler’s myocarditis (Chatterjee & Thakre, 1958) 2 gm - Vertigo in 75% but no deafness 1 gm - Vertigo in about 15% (Ormerod, 1954). Comment Was the dosage of streptomycin used unduly high for too long? The Canadians reduced their dosage from 2 G daily to 1G daily on November 1st 1947, but McDermott in 1947 said that it was probable that 3G represented the upper limit of the safe daily dose. Other papers published at this time did not suggest reducing the dosage. The MRC study started recruiting patients in January 1947 and the dosage of 2 G daily had been decided after speaking with Dr HC Henshaw, who had a wide experience and in his paper of 17th January 1948 he suggested that in TB the average daily dose be approximately 1G for a patient of average weight, but in November 1946 he had recommended for adults 1 to 3G per twenty-four hours. The difficulty in choosing a safe dose may have been due to: 1. The numerous forms of TB which demanded different doses, e.g. miliary TB, TB meningitis, different sites of the TB infection and a wide range of severity. 2. Causal factors for vestibular dysfunction: patient aged over 45 years, size of dose, duration of treatment, patient’s weight, a difference between complaints of giddiness on a single daily dose compared with divided doses during the day. 3. Varying purity and three different salts: Glaxo–S calcium chloride complex, Merck–S hydrochloride and Pfizer - S sulphate. Although the MRC study made little effort in exploring the adverse effects of streptomycin most of the relevant facts had been established by the previous case series. Histamine release due to impurities suggests an anaphylactoid reaction due to instant release of histamine without developing hypersensitivity whereas the anaphylactic reactions only occurred after prior hypersensitzation. The injection site reactions also seem to have been due to impurities and also do not occur after 1948, The fact that fever is not mentioned after 1948 suggests that too maybe due to impurities but not connected with injection site reaction as its time to onset and duration are rather too long and there is no mention of a relationship. Renal casts and albuminuria are not mentioned after 1948 when purified streptomycin became available so they too may have been due to impurities. Nausea and vomiting developed about six weeks after the start of the trial and they were also thought to be due to impurities as they ceased when the pure streptomycin became available
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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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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 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
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 316 and 317: (Crofton, 2009). Asthma, pancytopen
Page 318 and 319: Ideal knowledge of an ADR How much
Page 320 and 321: Table 13. Number of first reports o
Page 322 and 323: Despite these actions the prescribe
Page 324 and 325: Remedy, the active ingredient was D
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 334 and 335: have expected that it would have be
Page 336 and 337: the poor economic status of these a
Page 338 and 339: SED 1952: no mention. A warning was
Page 340 and 341: Withdrawn: over-the-counter sales w
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 360 and 361: area and degree of inflammation. 19
Page 362 and 363: 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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