Hostname: page-component-8448b6f56d-t5pn6 Total loading time: 0 Render date: 2024-04-18T04:31:25.564Z Has data issue: false hasContentIssue false
  • English
  • Français

Evaluation of safety and side effects in the process of anti-anxiety drug development *

Published online by Cambridge University Press:  16 April 2020

M Bourin ,
A Couetoux du Tertre  and
R Payeur
M Bourin
Affiliation:
Laboratoire de Pharmacologie, Faculté de Médecine et GIS Médicament, 44035Nantes, France
A Couetoux du Tertre
Affiliation:
Laboratoire de Pharmacologie, Faculté de Médecine et GIS Médicament, 44035Nantes, France
R Payeur
Affiliation:
Centre Hospitalier Pierre Janet, 20, rue Pharand, Hull J9A 1K7, PQ, Canada
Get access

Summary

As with other drugs it is necessary to look for changes induced by anxiolytics on vital signs, laboratory parameters and adverse events. In return, in a more specific way for anxiolytics, we will look at side effects at the central nervous system level with psychological and physiological battery tests. We will also assess the safety of use of anxiolytics in certain specific conditions, such as overdose or withdrawal and in certain populations such as the elderly, neonates and children. The assessment of safety and side effects, whatever the drug type studied, must come early in the developing process of a drug (phases I, II and III).

Keywords

side effectsanxiolytics
Type
Methodology
Information
European Psychiatry , Volume 8 , Issue 6 , 1993 , pp. 285 - 291
Copyright
Copyright © Elsevier, Paris 1993

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Aranko, K, Seppala, T, Mattila, MJ (1985) Interaction of diazepam or lorazepam with alcohol. Psychomotor effects and bioassayed serum levels after single and repeated doses. Eur J Clin Pharmacol 28, 559–565CrossRefGoogle ScholarPubMed
American Psychiatric Association (1987) Diagnostic and Statistical Manual of Mental Disorders. 3rd Edition Revised. Washington, DCGoogle Scholar
Bittencourt, PR, Wade, P, Smith, AT, Richens, A (1981) The relationship between peak velocity of saccadic eye movements and serum benzodiazepine concentration. Br J Clin Pharmacol 12, 523–533CrossRefGoogle ScholarPubMed
Bond, AJ, Lader, MH (1974) The use of analogue scales in rating subjective feelings. Br J Med Psychol 47, 211–218CrossRefGoogle Scholar
Bourin, M, Breteau, M (1979) Intoxications aiguës par les benzodiazépines. Toxicol Eur Res 2, 163–167Google Scholar
Bourin, M (1988) Une échelle pour évaluer le sevrage induit par les anxiolytiques. Encéphale 14, 283–285Google Scholar
Bourin, M (1989) Les benzodiazépines. De la pharmacocinétique à la dépendance. Ed Ellipses. ParisGoogle Scholar
Bressler, R (1987) Multiple drug use in an elderly man. Hosp Pract July 111–127CrossRefGoogle Scholar
Burrows, G, Norman, Τ, Judd, F, Marriott, Ρ (1990) Shortacting versus long acting benzodiazepines: discontinuation effects in panic disorders. J Psychiatr Res 24 suppl 2, 65–72CrossRefGoogle Scholar
Cook PJ, (1986) Benzodiazepine hypnotics in the elderly. Acta Psychiat Scand 74 (suppl 332) 149–158CrossRefGoogle Scholar
Cowen, PJ, Anderson, IM, Grahame-Smith, DG (1990) Neuroendocrine effects of Azapirones. J Clin Psychopharmacol 10 suppl 3, 21S–22SCrossRefGoogle ScholarPubMed
Derogatis, LR, Lipman, R, Rickels, K, Uhlenhuth, E, Covi, L (1974) The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci 19, 1–15CrossRefGoogle ScholarPubMed
Dupont, R (1990) A practical approach to benzodiazepine discontinuation. J Psychiatr Res 24 suppl, 2, 81–90CrossRefGoogle ScholarPubMed
Fialip, J, Aumaitre, O, Eschalier, A, Maradeix, B, Dordain, G, Lavarenne, J (1987) Benzodiazpine withdrawal seizures: analysis of 48 case reports. Clin Neuropharmacol 10, 538–544CrossRefGoogle Scholar
Gammans, RE, Westrick, ML, Shea, J, Mayol, RF, Labudde, JA (1989) Pharmacokinetics of buspirone in elderly subjects. J Clin Pharmacol 29, 72–78CrossRefGoogle ScholarPubMed
Golombo, KS, Moodley, P, Lader, M (1988) Cognitive impairment in long term benzodiazepine users. Psychol Med 18, 365–374CrossRefGoogle Scholar
Greenblatt, D, Shader, R (1974) Drug therapy. Benzodiazepines. N Engl J Med 91, 1011–1015, 1239-1243CrossRefGoogle Scholar
Greenblatt, D, Miller, L, Shader, R (1990) Benzodiazepine discontinuation syndromes. J Psychiat Res 24, suppl, 2, 73–79CrossRefGoogle ScholarPubMed
Guelfi, JD, Pull, CB, Guelfi, C, Ruschel, S, Dreyfus, JF (1983) La CHESS Utilisation dans la pathologie anxieuse et dépressive. Structure factorielle. Ann Med Psychol 141, 257–277Google Scholar
Hamilton, M (1959) The assessment of anxiety states by rating. Br J Med Psychol 32, 50–55CrossRefGoogle ScholarPubMed
Hindmarch, I (1980) Psychomotor function and psychoactive drugs. Br J Clin Pharmacol 10, 189–209CrossRefGoogle ScholarPubMed
Hindmarch, I, Gudgeon, AC (1982) Loprazolam (HR 158) and flurazepam with ethanol compared on tests of psychomotor ability. Eur J Pharmacol 23, 509–512Google ScholarPubMed
Jansen, A AI, Verbaten, MN, Slangen, JL (1988) Acute effects of bromazepam on signal detection performance, digit symbol substitution test and smooth pursuit eye movements. Neuropsychobiology 20, 91–95CrossRefGoogle ScholarPubMed
Kanto, J, Sellman, K, Haataja, M, Hurme, Ρ (1978) Plasma and urine concentrations of diazepam and its metabolites in children, adults and in diazepam intoxicated patients. Int J Clin Pharmacol Biopharm 16, 258–264Google ScholarPubMed
Lader, M (1987) Long-term anxiolytic therapy: the issue of drug withdrawal. J Clin Psychiatr 48 (suppl 12) 12–16Google ScholarPubMed
Lader, M, File, S (1987) The biological basis of benzodiazepine dependence. Psychol Med 17, 539–547CrossRefGoogle ScholarPubMed
Lakshminarayan, S, Sahn, S, Hudson, L, Weil, J (1976) Effect of diazepam on ventilatory responses. Clin Pharmacol Ther 20, 178–183CrossRefGoogle ScholarPubMed
Lippmann, S (1987) Geriatric aspects of psychopharmacology. Part B. J Ky Med Assoc June 337–340Google ScholarPubMed
McManus, IC, Ankier, SI, Norfolk, J, Philipps, M, Priest, RG (1983) Effects on psychological performance of the benzodiazepine, loprazolam, alone and with alcohol. Br J Clin Pharmacol 16, 291–300CrossRefGoogle ScholarPubMed
Marks, J (1985) The Benzodiazepines: Use, Overuse, Misuse, Abuse. Second edn, MTP Press, LancasterGoogle Scholar
Martinet, JP, Trebon, P, Meillard, MN, Reymann, JM, Moran, P, Lieury, A, Allain, H (1989) Memory assessment in elderly healthy volunteers through a short term double-blind clinical trial. Fund Clin Pharmacol (Abstr) 3, 465–466Google Scholar
Mellman, A, Udhe, W (1988) Withdrawal syndrome with gradual tapering of alprazolam. Am J Psychiatr 45, 444–450Google Scholar
Merz, WA, Ballmer, U (1983) Symptoms of the barbiturate withdrawal syndrome in healthy volunteers: standardized assessment by a newly developed self-rating scale. J Psychoact Drugs 15, 1–2, 71-84CrossRefGoogle ScholarPubMed
Murasaki, M, Miura, S, Ishigooka, J, Ishii, Y, Takahashi, A, Fukuyama, Υ (1989) Phase I study of a new antianxiety drug, Buspirone. Prog Neuropsychopharmacol Biol Psychiatr 13, 137–144CrossRefGoogle ScholarPubMed
Parrott, AC (1991a) Performance tests in human psychopharmacology. Test rehability and standardization. Human Psychopharmacol 6, 1–9CrossRefGoogle Scholar
Parrott, AC (1991b) Performance tests in human psychopharmacology: content validity, criterion validity and face validity. Human psychopharmacol 6, 91–98CrossRefGoogle Scholar
Parrott, AC (1991c) Performance tests in human psychopharmacology: construct validity and test interpretation. Human Psychopharmacol 6, 197–207CrossRefGoogle Scholar
Pecknold, J, McClure, D, Fleuri, D, Chang, H (1982) Benzodiazepine withdrawal effects. Prog Neuro Psychopharmacol & Biol Psychiatr 6, 517–522CrossRefGoogle ScholarPubMed
Petursson, H, Lader, M (1984) Benzodiazepine withdrawal.In: Dependence on Tranquilizers. Oxford University Press 130Google Scholar
Pierce, MW, Shu, VS, Groves, LJ (1990) Safety of estazolam. Am J Med 88, suppl 3A, 125–175CrossRefGoogle ScholarPubMed
Prescott, LF (1983) Safety of benzodiazepines.In: The Benzodiazepines. From Molecular Biology to Clinical Practice (Costa, E, ed). Raven Press NY, pp. 253–265Google Scholar
Rapoport, DM, Greenberg, HE, Goldring, RMComparison of the effects of buspirone and diazepam on control of breathing. Faseb J 2, A 1507Google Scholar
Rickels, K, Schweizer, E, Case, G, Greenblatt, D (1990) Long-term therapeutic use of benzodiazepines. I. Effects of abrupt discontinuation. Arch Gen Psychiatr 47, 899–907CrossRefGoogle ScholarPubMed
Roy-Byrne, P, Cowley, D EDS (1991a) Benzodiazepines: Dependence and withdrawal.In: Benzodiazepine: In Clinical Practice. Risks and Benefits. 133–153Google Scholar
Roy-Byrne, P, Cowley, D EDS (1991b) Use of benzodiazepines in the elderly.In: Benzodiazepine: In Clinical Practice. Risks and benefits. 215–227Google Scholar
Roy-Byrne, P, Cowley, D EDS (1991c) Cognitive and psychomotor effects.In: Benzodiazepine: In Clinical Practice. Risks and Benefits. 113–121Google Scholar
Roy-Byrne, PP, Hommer, D (1988) Benzodiazepine withdrawal: overview and implications for the treatment of anxiety. Am J Med 84, 1041–1051CrossRefGoogle ScholarPubMed
Schweizer, E, Rickels, K, Case, G, Greenblatt, D(1990) Long-term therapeutic use of benzodiazepines. II. Effects of Gradual taper. Arch Gen Psychiatr 47, 908–915CrossRefGoogle ScholarPubMed
Sellers, EM (1978) Clinical pharmacology and therapeutic of benzodiazepines. Can Med Ass J 118, 1533–1538Google ScholarPubMed
Setekliev, J, Bo, O, Wickstrom, E, Enoshen, A, Hasvold, I, Sukchang, J (1980) Alcohol and drugs in accident victims a one year series from a Norwegian hospital. J Traf Med 8, 26–30Google Scholar
Straughan, JL, Conradie, EA (1988) Buspirone-frontrunner of a new genre of anxiolytics. S Afr Med J 74, 441–444Google ScholarPubMed
Teboul, E, Chouinard, G (1991) A guide of benzodiazepine selection. Part II: Clinical aspects. Can J Psychiatr 36,62–73CrossRefGoogle ScholarPubMed
Tyrer, P, Murphy, S, Riley, Ρ (1990) The benzodiazepine withdrawal symptom questionnaire. J Affect Disord 19, 53–61CrossRefGoogle ScholarPubMed
Walser, A, Safran, A, Schulz, P, Meyer, JJ (1987) Effects of small doses of bromazepam on pupillary function and on flicker perception in normal subjects. J Clin Psychopharmacol 7, 59–60Google ScholarPubMed
Submit a response

Comments

No Comments have been published for this article.