OPINIONS, STATEMENTS ETC FROM REGULATORY AND OTHER AUTHORATIVE ORGANISATIONS - RE DEPENDENCE / ADDICTION INCLUDING DRUG COMPANY ADVERTS
See also PDR, BNF, ABPI and other data sheets world wide.
1. WHO (1957) Tech. Rep. Ser. 116
Recognition of addiction/withdrawals of tranquilizing agents such as barbiturates and meprobamates. Definition of drug addiction and barbiturates: recognition of need for change.
2. AMA Council on Drugs (1963) New and Non Official Drugs (NND) 1963 p.498 (JAMA July 27, 1963, p152)
Information for Chlordiazepoxide (source: Hoffman La Roche) - withdrawal symptoms like barbiturates, wide range of adverse reactions.
3. Physicians Desk Ref (PDR) (1963) Ed. 17
Chlordiazepoxide causes states of intoxication and physical dependence similiar to those induced by barbiturates. Recommended adult dose up to 300 mg daily, and can be given at 6 hour intervals.
4. Essig C F Clinical Pharmacology and Therapy 1963, 5, 334 - 343
National List of Mental Health/Addiction Research Centre, US Department of Health, Education and Welfare, Public Health Service. Addiction to Non-Barbiturate sedatives and tranquillizer drugs.
5. BMJ (1964) Editorial Article, Drugs of Addiction - 2 BMJ 31 Oct. 1964, 1119 - 1120
Gives list of non-barbiturate sedative/hypnotic drugs ..... there are chemical differences between them, but they have closely similiar liability to cause dependence. Librium given in list of substances especially liable to cause dependence.
6. WHO (1964) Tech Rep Ser. 287
Tests for evaluation of dependence producing drugs, animals/humans. Good correlation between animal/human test results. Chlordiazepoxide a good substitute for barbiturates in animals.
7. WHO (1964) Tech Rep Ser. 273
Definition: replacement of habituation/addiction with dependence. Definitions of generic 'types' of drug dependence eg. 'barbiturate type' for minor tranquillizers.
8. Roche (1964) 1st Advert for Valium JAMA April 6 p 70 - 71, 1964
Abrupt cessation after prolonged use .... may produce withdrawal symptoms similiar to those seen with barbiturates, Meprobamate and Librium.
9. WHO (1965) Bull. 32
Definitions of types of drug dependence. Use of 'dependence' has no scientific validity unless associated with 'type' of dependence. Chlordiazepoxide given in list of drugs causing barbiturate/alcohol type of dependence - all of which have substantial cross tolerance.
10. Committee on Alcoholism and Addiction / Council on Mental Health (AMA) (1965) - Dependence on Barbiturates and Other Sedative Drugs JAMA Aug 23, 1968, 193, 107 - 111.
Diazepam and Chlordiazepoxide given in list of drugs with a barbiturate - like action capable of producing both physical and psychological dependence.
11. Wyeth (1965) JAMA, 192, p 231 - 33 Wyeth Advert for Oxazepam
Excessive and prolonged use .. may result in dependence. Abrupt discontinuance ..... may result in epileptiform seizures.
12. National Institue of Mental Health/Addiction Research Centre (1966) - US Dept. of Health, Education and Welfare, Public Health Service
'New Sedative Drugs that can Cause States of Intoxication and Dependence of Barbiturate Type' JAMA May 23, 1966, 105, 126 - 129. Essig CF Lists seven non-barbiturate drugs, including diazepam and chlordiazepoxide.
13. FDA, US Dept, of Health, Education and Welfare (1966) Non-narcotic Addiction - Size and Extent of the Problem JAMA, May 23, 196, 196, 119 - 121. Sadusk J F
Stresses the dangers of addiction and dependence caused by non-barbiturate sedative drugs as listed by Essig (10).
14. PDR 1967 Entry for Librium Physical and Psychological Dependence and Withdrawals of Barbiturate Type reported.
Nb. All subsequent PDRs reported physical and psychological dependence for Librium, Valium and other benzodiazepines.
15. B.N.F. (1968)
Barbiturates, amphetamines and non phenthiazine tranquillizers (minor tranquillizers) are considered liable to lead to dependence. More patients become dependent on these drugs than opiates. Librium and Valium clinical trials failed to show clear distinction between these drugs and barbiturates and meprobamate (now obsolescent) or placebo.
16. Hoffman Le Roche (1968) - Some aspects of the Expt. & Clinical Toxicology of Chlordiazepoxide. Regianni et al. Proc. Eur Soc. of Drug Toxicity Vol 1X 1968.
Assessed intensity of both physical dependence and severity of abstinence syndrome as moderate and similiar to meprobamate, with months for creation of dependence. By the late 1960s meprobamate was not recommended for prescribing in the UK because of its high addiction potential (See 13 above).
17. Roche (1969) JAMA p 1389 17/2/69
Withdrawal symptoms occurred following abrupt discontinuation.
18. WHO (1970)
Dependence liability of Non-Narcotic Drugs Classified 15 Benzodiazepines including Librium, Valium and Mogadon as drugs of dependence.
19. WHO (1973) Tech Rep. Ser. 526
Librium and Valium as drugs causing dependency of the alcohol / barbiturate type.
20. WHO (1975)
On Evaluation Tests for Drug Dependency. Quite a few benzodiazepines shown to produce withdrawals in animal tests.
21. WHO (1978)
On animal/Human studies showing reinforcing effect of non-barbiturate sedative hypnotics.
22. FDA (1978)
Internal Memorandum recommending that for each of the marketed benzodiazepines, the labelling should include, 'withdrawal symptoms have been reported for this class of drugs after abrupt discontinuance of therapeutic levels taken continuously for several months.'
N.B. This memorandum is from US Congress Hearings 1979 on the Benzodiazepines: Use and Misuse and is recognition of many papers in the literature on addiction/withdrawals at therapeutic level. These problems are indicative of tolerance occuring (transcripts of the hearing yet to be fully assessed by VOT.
23. IOM, National Academy of Sciences, Washington DC (1979) 'Sleeping Pills Insomnia and Medical Practice'
........ only flurazepam has been shown to affect sleep for as long as 28 days of continuous use ..... most other hypnotics ... lose their sleep promoting properties within 3 - 14 days of continuous use.
....... the barbiturates and the benzodiazepines are probably equally effective in short term use .. Benzodiazepines share a number of hazards with the barbiturates ..... insufficient recognition has been given to undesirable or hazardous effects of long acting benzodiazepines that are not found with the barbiturates.
(complete transcripts yet to be obtained and assessed).
24. CRM (1980) Systematic Review of the Benzodiazepines BMJ 29 March 1980 910 - 912
No evidence to justify the preferential use of any particular benzodiazepines in either anxiety or insomnia - division into rigid categories not based on known pharmacological or clinical properties.
High proportion of patients recieving repeat prescriptions for extended periods of time.
Most hypnotics tend to lose sleep promoting properties in 3 to 14 days and anxiolytics were not efficacious after 14 months.
25. Effects of tranquillizer use: benzodiazepine use in Canada. Health Promotion Directorate, Health and Welfare, Canada, Ottowa, Ontario (1982)
Continuous use should not exceed 2 weeks. Dependence on diazepam is estimated to occur from 2 weeks to 4 months depending on dose.
26. WHO (1983) Use and abuse of Benzodiazepines Bull 61(4) 551 - 562 (1983)
Review of current knowledge. Animal/human dependence studies. Therapeutic dependency.
27. WHO (1984) '33 Tranquillizers Placed under International Control
Press Release WHO Feb 1984
List of 33 benzodiazepines as dependence producing drugs.
28. Royal College of Psychiatrists (1987) Drug Scenes.
A report on drugs and drug dependency by the Royal College of Psychiatrists (1987). No single underlying trait or unique constellation of personality features can be identified as pre-disposing to drug misuse. It is at the sad end of the addiction spectrum that severe personality problems will be found in cluster. It is improbable that gross mental illness is ever likely to make more than a marginal contribution to drug misuse.
29. CSM (1988) Benzodiazepine Dependence and Withdrawals.
All benzodiazepines equally likely to produce dependency and withdrawal symptoms. Withdrawal symptoms can occur with therapeutic doses for short periods of time.
Length of prescribing 2 - 4 weeks for anxiolytics and hypnotics.
Benzodiazepines for insomnia only when severe, disabling or with extreme distress.
30. The Royal College of Psychiatrists (1988) 'Benzodiazepine and Dependence'
Benzodiazepines should not be prescribed for anxiety or insomnia for more than one month and not every night for insomnia. The consequences of long term prescribing are liable to far outweigh symptomatic relief. Dependence on Benzodiazepines in therapeutic doses is common. The longer the use of Benzodiazepines the longer the reduction period - 2 weeks for even short term (one month) use.
31. WHO (1990) Life after Benzodiazepine Withdrawal WHO Drug Information 4, 2, 1990, 53 - 54.
Dependence a frequent complication of long term use. Little objective information on the long term range outcome of controlled withdrawal.
32. Roche Products (c 1990) 'Benzodiazepines and Your Patients, a Management Programme - Two Sections. The Prescribing of and Withdrawal from Benzodiazepines and Benzodiazepines and their Equivilents.
Full recognition of dependency and its problems, description of methods to achieve abstinence.
Post withdrawal syndrome can last at least a year and can consist of poor concentration, abdominal discomfort, depersonalisation, malasise and emotional liability etc.
33. American Psychiatric Association - Task Force Report on Benzodiazepines - Dependence, Toxicity and Abuse. Annual Journal of Psychiatry Feb 1991, 151 -152
Potential for dependency and toxicity should be considered before prescribing. Patients who recieve benzodiazepine should be informed of these risks. For prolonged periods (or high doses) toxicity and dependence may increase in the frequency and severity.
34. WHO (1993) Tech Rep. Ser. 836
Changes to defintions drug dependence and withdrawals. Distinctions between psychological and physiological dependency is unobtainable in a clinical setting - all drug dependence is understandable in biochemical terms.
ICD - 10 Classification of drug dependence.
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