Introduction - Uppsala Monitoring Centre

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(Crofton, 2009). Asthma, pancytopenia, aplastic anaemia, haemolytic anaemia, Stevens-Johnson syndrome, peripheral neuritis, encephalopathy, neuromuscular block, anosmia and loss of concentration were all discovered after 1957 suggesting that they might be very rare. Fiedler’s myocarditis was probably a single case (Chatterjee & Thakre, 1958). The case series prior to 1948 seem to have been effective in discovering the commoner ADRs. Of those ADR mentioned in SED 2000: Stevens-Johnson Syndrome. The original description was given in 1922 (Stevens and Johnson, 1922) George Orwell probably suffered it as an ADR to Streptomycin in 1947. There was a single case published in 1982 (Sarker et al., 1982) A case of toxic erythema with generalising follicular pustules with a positive rechallenge appeared in 1981 (Shimoto & Aoki, 1981). Anosmia. A survey of 300 patients found 8 cases of anosmia and 13 cases of hyposmia, but all but two had had anosmia before streptomycin (Kereković & Curkević, 1971) an allusion to 5 case of olfactory disturbance was made in 2003 (Welge-Luessen & Wolfensberaed, 2003). Haemolytic anaemia. A single case of immune haemolytic anaemia and renal failure was reported in 1977 (Martinez-L et al., 1977) and a similar case in 1962 (Nachman et al., 1962). Peripheral neuritis. First reported in 1971 (Herishahy & Tauste, 1971). The small number of patients involved in these late reported cases suggests that they are rare and that their discovery probably resulted from the large number of patients treated over the years. Most of the ADRs were discovered via individual reports or small case series and the MRC Trial added little to our knowledge of the ADRs. In the USA where they had started with individual cases and case series the dramatic improvements meant that controlled studies would be unethical, but the dramatic improvement only became clear after a controlled study had started and since there was sufficient drug available to treat patients the placebo control study was unethical and was stopped. The situation was different in the UK as there was insufficient drug to treat all the patients so a placebo group was ethical (Green, 1954). Streptomycin was more vestibule-toxic than dihydrostreptomycin, but this was frequently reversible. Di-hydrostreptomycin was more cochleo-toxic and the resulting deafness was nearly always permanent. The advent of streptomycin made little difference to the already declining death rate of tuberculosis (McKeown, 1976). Discussion on Part Two First we will take a look at the amount of knowledge that we have on single representative ADR for each marker drug.
Table 11. Knowledge of adverse reactions to the marker drugs By choosing the most common ADRs one automatically rules out most type B reactions and some of the categories are not relevant. In type ‘A’ reactions confidence limits for incidences would only be relevant at a standard dosage. Although under ‘factors’ only dose is mentioned there may also be idiosyncratic predisposition, e.g. salivation with mercury. Manifestation Vomiting Madness Salivation or ptyalism Nausea Tinnitus VIII cranial nerve. Giddiness usually appearing in the 4/5 th week. Deafness (rare) Severity +++ Variable Variable Vomiting + +++ Seriousness Potentially +++ No + No +++ Incidence Dose related Dose related Dose related Dose related Dose related 65% - 68% Absolute Dose related Dose related Dose related Dose related 9 of 58 36 of 55 Relative to competitors More than most other emetics ? Not with other syphilis treatments Affects 2/3 of patients Occurs with all salicylates CIs ? ? ? ? ? ? More than dihydrostreptomycin Mechanism Type ‘A’ Type ‘A’ Type ‘A’ Type ‘A’ Type ‘A’ Type ‘A’ Causality Certain Certain Certain Certain Certain Certain Factors Dose (see 78, 1619, 1652 & 1694) Treatment Stop Stop Reduce dose Dose Dose, age Dose Dose Renal function, age, weight (see above) Anti-emetic or reduce dose Reduce dose Reduce dose Effective Yes Yes Yes Yes Yes Usually Reversible Yes Yes Yes Yes Yes Not always Sequelae Dehydration ? Nil Dehydration Nil Possible
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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
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 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
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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
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
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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 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
Page 364 and 365: 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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