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Auteur S. ALMENARA |
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The challenge of detecting adverse events in adults with autism spectrum disorder who have intellectual disability / P. BALLESTER in Autism Research, 15-1 (January 2022)
[article]
Titre : The challenge of detecting adverse events in adults with autism spectrum disorder who have intellectual disability Type de document : Texte imprimé et/ou numérique Auteurs : P. BALLESTER, Auteur ; C. ESPADAS, Auteur ; A. C. LONDOÑO, Auteur ; S. ALMENARA, Auteur ; Víctor AGUILAR, Auteur ; C. BELDA, Auteur ; E. PÉREZ, Auteur ; J. MURIEL, Auteur ; A. M. PEIRO, Auteur Article en page(s) : p.192-202 Langues : Anglais (eng) Mots-clés : Adult Autism Spectrum Disorder/drug therapy Humans Intellectual Disability Male Prospective Studies Psychotropic Drugs/therapeutic use Retrospective Studies adverse events autism spectrum disorder pharmacovigilance Index. décimale : PER Périodiques Résumé : Adults with autism spectrum disorder (ASD) and associated intellectual disability (ID) take a high number of different psychotropic drugs simultaneously. Nowadays, little is known about this multidrug pattern efficacy and safety. The present study has endeavored to fill this gap creating a local pharmacovigilance system. A 36-month, retrospective and prospective, observational, and multicenter pharmacovigilance study was carried out in adults with ASD and ID (n = 83). Information regarding ongoing medications (polypharmacy: taking simultaneously >4 drugs; safety profile: adverse events' number, adverse drug reactions' number, and affected system; and observed-to-expected [O/E] ratio using the summary of product characteristics), and current diagnoses were recorded. A median of four ongoing medications per participant was registered, half of the sample was under polypharmacy regimen. Regarding all ongoing medications, 50% were antipsychotic drugs, and 47% of participants had >1 antipsychotic prescribed. In contrast, only 64 adverse events were identified from electronic health records, mostly due to risperidone. Half of them were related either to nervous or metabolic systems, and almost a third were not previously described in the corresponding drug summary of products characteristics. Extrapyramidalism, gynecomastia, hypercholesterolemia, and urinary retention were some AEs that occurred more frequently than expected (O/E ratio?>?6 times) according to our data. The highest O/E ratio scores (>120 times) were for hypercholesterolemia and rhabdomyolysis caused by valproic acid. According to the number of adverse events and adverse drug reactions reported in electronic health records locally and nationally by clinicians, we need to increase awareness about medications safety. LAY SUMMARY: A 36-month study in adults with autism, ID, and polypharmacy (>4 drugs) was done to investigate drug safety on everyone. A median of four medications per person was registered, half were antipsychotic drugs, and 47% of participants had >1 antipsychotic medication simultaneously. Only 64 adverse events were identified from electronic health records, mostly due to risperidone. Half of them were related to nervous or metabolic systems and a third were not previously described in the drug information sheet. En ligne : http://dx.doi.org/10.1002/aur.2624 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=450
in Autism Research > 15-1 (January 2022) . - p.192-202[article] The challenge of detecting adverse events in adults with autism spectrum disorder who have intellectual disability [Texte imprimé et/ou numérique] / P. BALLESTER, Auteur ; C. ESPADAS, Auteur ; A. C. LONDOÑO, Auteur ; S. ALMENARA, Auteur ; Víctor AGUILAR, Auteur ; C. BELDA, Auteur ; E. PÉREZ, Auteur ; J. MURIEL, Auteur ; A. M. PEIRO, Auteur . - p.192-202.
Langues : Anglais (eng)
in Autism Research > 15-1 (January 2022) . - p.192-202
Mots-clés : Adult Autism Spectrum Disorder/drug therapy Humans Intellectual Disability Male Prospective Studies Psychotropic Drugs/therapeutic use Retrospective Studies adverse events autism spectrum disorder pharmacovigilance Index. décimale : PER Périodiques Résumé : Adults with autism spectrum disorder (ASD) and associated intellectual disability (ID) take a high number of different psychotropic drugs simultaneously. Nowadays, little is known about this multidrug pattern efficacy and safety. The present study has endeavored to fill this gap creating a local pharmacovigilance system. A 36-month, retrospective and prospective, observational, and multicenter pharmacovigilance study was carried out in adults with ASD and ID (n = 83). Information regarding ongoing medications (polypharmacy: taking simultaneously >4 drugs; safety profile: adverse events' number, adverse drug reactions' number, and affected system; and observed-to-expected [O/E] ratio using the summary of product characteristics), and current diagnoses were recorded. A median of four ongoing medications per participant was registered, half of the sample was under polypharmacy regimen. Regarding all ongoing medications, 50% were antipsychotic drugs, and 47% of participants had >1 antipsychotic prescribed. In contrast, only 64 adverse events were identified from electronic health records, mostly due to risperidone. Half of them were related either to nervous or metabolic systems, and almost a third were not previously described in the corresponding drug summary of products characteristics. Extrapyramidalism, gynecomastia, hypercholesterolemia, and urinary retention were some AEs that occurred more frequently than expected (O/E ratio?>?6 times) according to our data. The highest O/E ratio scores (>120 times) were for hypercholesterolemia and rhabdomyolysis caused by valproic acid. According to the number of adverse events and adverse drug reactions reported in electronic health records locally and nationally by clinicians, we need to increase awareness about medications safety. LAY SUMMARY: A 36-month study in adults with autism, ID, and polypharmacy (>4 drugs) was done to investigate drug safety on everyone. A median of four medications per person was registered, half were antipsychotic drugs, and 47% of participants had >1 antipsychotic medication simultaneously. Only 64 adverse events were identified from electronic health records, mostly due to risperidone. Half of them were related to nervous or metabolic systems and a third were not previously described in the drug information sheet. En ligne : http://dx.doi.org/10.1002/aur.2624 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=450