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Codeine and Its Alternates for Pain and Cough Relief* 1

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Codeine and Its Alternates for Pain and Cough Relief* 1 Bull. Org. mond. Sante 1 1968, 38, 673-741 Bull. Wld Hlth Org. Codeine and its Alternates for Pain and Cough Relief* 1. Codeine, Exclusive of its Antitussive Action NATHAN B. EDDY, M.D.,1' HANS FRIEBEL, Dr. med.,2 KLAUS-JORGEN HAHN, Dr. med.3 & HANS HALBACH, Dr. med. Dr.-Ing.4 This report-thefirst ofa series on codeine and its alternates for pain and cough relief- presents a detailed evaluation of experimental and clinical data concerning the analgesic action of codeine (the antitussive action will be assessed separately). The authors discuss the pharmacology of the drug, including side-effects and toxicity; effects on the respiratory, circulatory, digestive and urinary systems; tolerance, dependence and liability to abuse; metabolic effects; and mechanism ofaction. Though codeine is generally more toxic than morphine to animals on account of its convulsant action, it is less toxic to man, possibly because it produces less respiratory depression. Again, tolerance to its analgesic effects has been demonstrated in several animal species, but dependence in man is observedfar less frequently than it is with morphine, and the abstinence syndrome is less intense. From their extensive review of the evidence available, the authors conclude that codeine is a good analgesic and that little risk to public health is likely to arise from its clinical use to relieve pain. CONTENTS INTRODUCTION ..... 673 EFFECT ON BLOOD ENZYMES AND OTHER ENZYME ANALGESIC ACTION . 676 SYSTEMS ..... .... ........ 707 SEDATIVE ACTION AND OTHER EFFECTS ON THE METABOLIC EFFECTS ... ...... 709 NERVOUS SYSTEM . ...... .. 693 TOXICrTy ..... ........ 710 . 695 SIDE-EFFECTS AND TOXIC REACTIONS TOLERANCE, DEPENDENCE AND ABUSE LIABILITY . 715 RESPIRATORY EFFECT . .. ....... 701 METABOLISM OF CODENE . 728 CIRCULATORY EFFECT . 703 EFFECT ON GASTROINTESTINAL TRACT AND OTHER RtSUm.................... 732 SMOOTH MUSCLE .704 REFERENCES ..... ....... 733 INTRODUCTION loid as the methyl ether of morphine was not Codeine, C1sH2l03N, the methyl ether of mor- established until 1881 (Grimaux, 1881), although phine, was first isolated in 1832 by Robiquet speculation to this effect had appeared earlier (1832, 1833), who found it as an impurity accom- (Matthiesson & Wright, 1870; Wright, 1872). panying morphine which had been extracted from Codeine is found in opium in much smaller opium. Gerhardt (1842, 1843) was the first to amount than morphine, usually between 0.2% and obtain analytical values corresponding to the true 0.8%. It has not been reported as appearing in empirical formula, but the character of the alka- any plant other than the poppy and has been * This review of the analgesic and antitussive effects of 1 Consultant, National Institutes of Health, Bethesda, codeine and its alternates is being published in the Bulletin Md., USA. of the World Health Organization in five instalments. The 2 Professor of Pharmacology and Toxicology, University first, presented here, is devoted to an assessment of codeine of Heidelberg, Germany. as a pain reliever. The second, third and fourth instalments will deal, respectively, with alternates for pain relief, the 2 Department of Medicine, University of Heidelberg, antitussive action of codeine, and potential alternates for Germany. cough relief. The final instalment will consist of a discussion ' Director, Division of Pharmacology and Toxicology, and summary of the preceding reviews. World Health Organization, Geneva, Switzerland. 2173 673- 674 N. B. EDDY AND OTHERS found in only two species of Papaveraceae. It is an increasing rate as time went on. In 1928, in the the second alkaloid to appear in the young plant, USA alone, the consumption of codeine amounted being detectable about 30 days after the seed to 3844 kg (US Treasury Department, Bureau of has sprouted. According to Rapport, Stermitz & Narcotics, 1928). In 1934, the first year for which Baker (1960), the sequence in biosynthesis, con- figures are available, world manufacture of co- firmed by feeding experiments with radioactive deine totalled 17 tons (Permanent Central Opium material, is thebaine to codeine to morphine. Board, 1948); in 1947, 42 tons (Permanent Central Poppy seeds do not contain codeine (Kerbosch, Opium Board, 1949); in 1953, 67 tons; and in 1910). 1963, 118 tons (Permanent Central Opium Board, The first therapeutic trials of codeine were re- 1964). In the USA, with a population increase ported in 1834. Barbier (1834), having given doses of about 50% from 1928 to 1963, codeine con- of one or two grains orally, noted the occurrence sumption increased almost fivefold, to 18 877 kg. of sleep without a feeling of heaviness, pain relief Initially, of course, codeine was derived from in some cases and euphoria on one occasion; Mar- opium, but, as therapeutic needs increased, it was tin (1834) reported improvement in tubercular obtained more and more by conversion of mor- cough after only one quarter of a grain of codeine phine. Of the reported world manufacture of orally; and Gregory (1834) of Edinburgh seems to morphine, 65 % was converted to codeine in 1934, have performed the first clinical pharmacological 80% in 1948, and slightly more than 90% in 1963. experiment with codeine. He gave it as the citrate A United States Pharmacopeia and National to some of his students and said that three grains Formulary survey of 10 000 prescriptions in 1931- orally had no effect, but that six grains caused 32 revealed that codeine was an ingredient in just acceleration of the pulse, a feeling of warmth under 900 of them. In 1940, at a meeting of the about the head and an exhilaration of the spirit. American Pharmaceutical Association in Rich- There was also generalized itching, and later de- mond, Va., M. J. Andrews reported that another pression, nausea and vomiting. Robiquet (1834), survey, covering 19 000 prescriptions, listed co- who placed great importance on the role of co- deine as an ingredient in 2190 per 10000. This deine in the action of opium, was surprised that later survey covered the states of Maryland, Penn- Gregory saw so little effect and attributed this to sylvania, Ohio, Virginia, West Virginia and the the use of a salt instead of the free base. Gregory District of Columbia. In later tabulations the fre- may have used a very impure sample of codeine quency of codeine-containing prescriptions was or, not too unlikely at that time, his students may lower, but such prescriptions still appeared well up have been using opium, so that this was a very on the list of popular remedies (FDC Reports, early record of cross-tolerance. Probably for simi- 1965), and today codeine continues to be one of lar reasons, Garrod (1864) also failed to obtain an the drugs most often used in medical practice. analgesic effect even with doses of five grains of Currently, 60-75 % of the codeine used in the USA codeine. Later, when effects with codeine were is in analgesic medication and only about 25% obtained, there was a very general belief that these in cough mixtures (estimate of the US Bureau of were due to the presence of morphine as a con- Narcotics), but 25% is almost 5000 kg, or more taminant, hence the weak and variable action (cf. than 70 000 000 fluid ounces of cough syrup. the current suggestion (Adler, 1962, 1963; San- There has been a levelling-off trend in the world filippo, 1953b; Johannesson & Schou, 1963), consumption of codeine in recent years (Perma- supported in part by the studies of metabolites, nent Central Opium Board, 1964), but the con- that codeine acts mainly through the morphine sumption remains high-a fact that is the more produced by demethylation in vivo). However, remarkable in view of the great effort which has Moore (1874) insisted that codeine acted inde- been made to find a worthy substitute and the pendently in its own right. Other early accounts many candidates to that end which have appeared. of a hypnotic effect and of the clinical usefulness Apparently the use of other agents has increased of codeine were published by Krebel (1856) and total analgesic and antitussive medication and, at Aran (1862). most, has only offset the increased codeine con- From these early beginnings the popularity of sumption which would have been expected as a codeine as a therapeutic agent grew slowly result of increasing world population and the through the remainder of the 19th century, but at broadening of medical coverage. And, again, in CODEINE AND ITS ALTERNATES FOR PAIN AND COUGH RELIEF. 1 675 the USA, despite the introduction of newer agents, tion. We must also be selective with respect to the growth rate for the use of codeine preparations pharmacological data, giving emphasis to more continues to increase: in the years 1963 to 1965, recent quantitative studies, but bearing in mind inclusive, it amounted to 15.7%. historical significance and pertinence to, or con- Small & Lutz (1932) reviewed the chemistry flict with, what appears to be the consensus to- and Krueger, Eddy & Sumwalt (1943) the phar- day. We shall, however, try to cover fairly com- macology of the opium alkaloids. Both reviews, pletely the literature on the alternates. Presumably of course, included codeine and its derivatives, but by 1870 codeine preparations of greater purity and both, unfortunately, have long been out of print. uniformity became available because about then Besides, the section on the pharmacology of co- reports on its efficacy became more consistent and deine was mainly a summary or tabulation of nearer to present-day evaluations. Bouchut (1872), what was found in the literature. Reynolds for example, as the result of observations on chil- & Randall (1957) have written a supplementary dren, 3-13 years of age, estimated the potency of review of the opium alkaloids, including some of codeine as one-third that of morphine. Brunton the newer derivatives and synthetic agents, but (1888) claimed that codeine was a powerful agent little space is given to codeine.
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