Introduction - Uppsala Monitoring Centre

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1957 Ethchlorvynol (Placidyl, Serenesil, Arvynol) Use: a non-barbiturate hypnotic. ADR: pulmonary oedema, alveolar infiltrates, pleural effusions and dependence after intravenous self-injection (Glauser et al., 1976; Van Swearingen, 1976). Dependency first reported in 1959 (Cahn, 1959). SED 1960 Ataxia, confusion, disorientation, visual and auditory hallucinations with convulsions on withdrawal. Withdrawn: restricted in the USA (became a schedule IV drug) and Canada in 1978. Availability: still killing patients in 1988 (Bailey & Shaw, 1990). Drug Lifespan: 21 years Delay in recognition: 19 years Delay in regulatory action: 2 years. Comment: abuse had lessened by 1990 but still occurred (Bailey & Shaw, 1990). 1957 Sulfamethoxydiazine (Sulfameter, Durenate, Bayrema) Use: a long acting sulphonamide antibacterial ADR: aplastic anaemia, agranulocytosis and thrombocytopenia (Schwank & Friedlanderova, 1977). Intrahepatic cholestasis (Horák et al., 1984). Stevens- Johnson syndrome (Staudt & Rudert, 1968). SED 1980, SED 1984, SED 1988: no mention but no longer used in the USA. Withdrawn: in Germany in 1988 Availability: not known Drug Lifespan: 31 years Delay in recognition: 9 years Delay in regulatory action: 20 years Comment: aplastic anaemia, agranulocytosis and thrombocytopenias are sulphonamide class effects (Albahary, 1953). 1957 Sulfamethoxypyridazine (Lederkyn, Kynex, Midicel) Use: long acting sulphonamide and antibacterial agent. ADR: aplastic anaemia, agranulocytosis and aplastic anaemia (Johnson and Korst, 1961), haemolytic anaemia (Janovsky, 1960), nephrotoxicity, fixed eruption, urticaria, and erythema multiforme (SJS) 176 . Skin reactions had occurred in 11.8% of patients (Lindsay et al., 1958). Of all the long-acting sulphonamides it is the most likely to cause Stevens-Johnson syndrome and caused at least eight deaths (Leader BMJ, 1964). Also reported thrombocytopenia, interstitial myocarditis and hepatitis (Melvin & Howie, 1961). SED 1960: of 672 patients 2.2% had rashes. There were two cases of thrombocytopenia. Fatal myocarditis and toxic psychosis.
SED 1963: agranulocytopenia, thrombocytopenias and pancytopenia. It is not proven that it is more toxic than the others. Withdrawn: an FDA warning that it could cause Stevens-Johnson syndrome was given in 1968 after a report of a large number of cases (Carroll et al., 1966). It was withdrawn in Canada in 1978, UK and Sweden in 1984; France, UK and United Arab Emirates in 1986, Pakistan in 1988, also Argentina. Commercial manufacture of the drug has been discontinued by at least one major manufacturer but supplies can still be obtained on special request, particularly for patients with dermatitis herpetiformis in which condition it has been claimed to be beneficial (WHO, 2003). Availability: not known Drug Lifespan: 21 years Delay in recognition: 4 years Delay in regulatory action: 17 years Time span of withdrawals: 10 years Comment: aplastic anaemia, agranulocytosis and thrombocytopenia are sulphonamide class effects (Albahary, 1953). 1957 Phenformin, Phenylethylbiguanide (Dibotin, Diphod) Marketed in the UK in 1969. Use: an antidiabetic drug (a biguanide) ADR: lactic acidosis. A study in 1959 showed that an early diguanide (phenethyldiguanide) caused lactic acidosis in 10% of patients and that it could be fatal (Walker and Linton, 1959). The first paper was ‘phenformin acidosis’ published in 1962 (Gottlieb, 1962). Several papers were published in 1963, one a report from a conference saying that ‘It is possible that Phenformin may add to the excess lactic acid.’ (Danowski et al., 1963); ‘another reported the death of two patients.’ (Bernier et al., 1963). A study of 330 cases of lactic acidosis showed that 86% had had phenformin, 9% buformin and 5% metformin (Ching et al., 2008; Luft, 1978). FDA office estimated that 4 in 1000 users died from lactic acidosis (Citizen Action Group, 1985). The frequency of lactic acidosis was estimated as 1 per 1110 patient-years (Stang, 1998). In 1960 it was found that the blood lactate and plasma hydrazine levels were raised at rest and this was exaggerated on exercise (BMJ, 1960). SED 1963: blood lactic acid raised. A paper published in 1978 (Bergmanet al., 1978) showed more cases of lactic acidosis with phenformin than with metformin. This paper led to the withdrawal in Sweden. The sale of phenformin in the United States went up after there was a threat that the drug would be withdrawn from the market (Lunde, 1980).
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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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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 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
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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
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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 406 and 407: of prescription drugs from worldwid
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
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Solecki RS. Shanidar IV, a Neandert
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Vépan. Gaz Medic. De Strassb. 1865
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