10/31/2023 0 Comments Paradoxical insomnia meaningTher Adv Musculoskelet Dis 11:1–6ĭika E, Varotti C, Bardazzi F, Maibach HI (2006) Drug-induced psoriasis: an evidence-based overview and the introduction of psoriatic drug eruption probability score. Joyau C, Veyrac G, Dixneuf V, Jolliet P (2012) Anti-tumour necrosis factor alpha therapy and increased risk of de novo psoriasis: is it really a paradoxical side effect? Clin Exp Rheumatol 30:700–706ĭel Giorno R, Iodice A, Mangas C, Gabutti L (2019) New-onset cutaneous sarcoidosis under tocilizumab treatment for giant cell arteritis: a quasi-paradoxical adverse drug reaction. Pharmacotherapy 24:1177–1185įiorino G, Danese S, Pariente B, Allez M (2014) Paradoxical immune-mediated inflammation in inflammatory bowel disease patients receiving anti-TNF-α agents. Mancuso E, Tanzi G, Gabay M (2004) Paradoxical reactions to benzodiazepines: literature review and treatment options. McKenzie WS, Rosenberg M (2010) Paradoxical reaction following administration of a benzodiazepine. Br J Clin Pharmacol 11:99–104ĭavies CJ, Davies DM (2001) Paradoxical reactions to commonly used drugs. Hall RW, Zisook S (1981) Paradoxical reactions to benzodiazepines. Weinbroum AA, Szold O, Ogorek D, Flasishon R (2001) The midazolam-induced paradox phenomenon is reversible by flumazenil: epidemiology, patient characteristics and review of the literature. Gutierez MM, Roper J, Pockhee H (2001) Paradoxical reactions to benzodiazepines: when to expect the unexpected. Accessed įigueras A, Pedrós C, Valsecia M, Laporte JR (2002) Therapeutic ineffectiveness: heads or tails? Drug Saf 25:485–487 Therapie 71:171–178ĪTC Structure and principles. Miremont-Salamé G, Théophile H, Haramburu F, Bégaud B (2016) Imputabilité en pharmacovigilance: de la méthode française originelle aux méthodes réactualisées. Therapie 74:557–567Įdwards IR, Aronson JK (2000) Adverse drug reactions: definitions, diagnosis, and management. Moore N, Berdai D, Blin P, Droz C (2019) Pharmacovigilance the next chapter. Hauben M, Aronson JK (2006) Paradoxical reactions: under recognized adverse effects of drugs? Drug Saf 29:911–1010 Smith SW, Hauben M, Aronson JK (2012) Paradoxical and bidirectional drug effects. The addition of the term “paradoxical reaction to the drug” to the list of other symptoms would facilitate their identification and analysis. In order to identify this type of ADR more effectively, work on awareness and harmonization is required to register these reports. Moreover, pharmacovigilance databases enable the identification of some signs of “unexpected paradoxical reactions”. This ADR was mainly found in the FPVDB with psychotropic drugs and immunomodulating agents. This study highlights that pharmacovigilance databases like the French database make it possible to investigate the main characteristics of paradoxical reactions to drugs. We also identified several “unexpected” paradoxical reactions, such as cognitive degradation with donepezil, or a return to impulsive smoking addiction with varenicline. For psychotropics, paradoxical ADRs occurred rapidly after a mean delay of 1 day, predominantly following high doses. ![]() Paradoxical reactions with immunomodulating agents were mainly related to skin ADRs ( n = 25). For psychotropic-induced PR ( n = 28), known contributory factors (alcohol consumption, underlying psychiatric diseases) were found in 18 cases (64%). In 19 cases (33%), PR was related to benzodiazepines mainly occurring in patients in extreme ages (five cases in children and patients > 70, respectively, 53%). ![]() The leading paradoxical ADRs were psychiatric (anxiety, sleep and behavioural disorders) and skin-related. ![]() The most frequently involved drugs were immunomodulating agents ( n = 28, 49%) and psychotropics ( n = 28, 49%). ![]() The median age of patients was 46 years, mainly male (54%). We found 57 reports of PR, with half of them recorded between 20. The drugs were classified according to the Chemical Therapeutic Anatomical Classification (ATC). We analysed all reports recorded in the FPVDB with drugs defined as “suspect” and which included the term “paradoxical reaction” (PR) (according to MedDRA classification) from to. The aim of the present study is to describe paradoxical ADRs using the French PharmacoVigilance DataBase (FPVDB). This kind of ADR may be particularly subject to under-notification. Their diagnosis is difficult as they are relatively rare with atypical clinical presentation (with the possibility of being confused with drug ineffectiveness or the worsening of the underlying disease). Paradoxical adverse drug reactions (ADRs) are defined as being opposing reactions to the pharmacological effect of drugs in relation to its pharmacodynamic properties.
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