Impact of histamine-2 antagonist shortage on the incidence of hypersensitivity reactions to paclitaxel: a reconsideration of premedication protocols in France (PACLIREACT Study).
Drug hypersensitivity
Drug shortage
Histamine-2 antagonists
Paclitaxel
Premedication
Journal
European journal of clinical pharmacology
ISSN: 1432-1041
Titre abrégé: Eur J Clin Pharmacol
Pays: Germany
ID NLM: 1256165
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
received:
14
02
2023
accepted:
29
06
2023
medline:
17
8
2023
pubmed:
13
7
2023
entrez:
12
7
2023
Statut:
ppublish
Résumé
An international shortage of ranitidine led to adjustments in premedication regimens for paclitaxel-based chemotherapy in early October 2019. In this study, we implemented and evaluated an anti-allergic protocol without histamine-2 antagonists (H2As) and aimed to assess the risk of hypersensitivity reactions (HSRs) to the different premedication regimens used. We conducted a single-center observational retrospective study of paclitaxel administrations (7173 administrations in 831 patients). Between January 2019 and December 2020, all allergies reported were recorded. A mixed logistic regression model was implemented to predict the risk of allergy at each injection and to account for repeated administration per patient. A total of 27 HSRs occurred in 24 patients. No protective effect was observed for H2A when comparing paclitaxel injections with H2A premedication versus without H2A (OR = 1.12, p = 0.84). There was also no significant difference in risk of HSR for famotidine versus ranitidine (OR = 0.79, p = 0.78). However, the risk of HSRs was significantly lower for paclitaxel injections with corticosteroids than for those without (OR = 0.08, p = 0.03). In addition, the risk of HSR was significantly higher for the first, second, or third paclitaxel injections than for the subsequent injections (OR = 10.1, p < 0.001). We did not find substantial evidence of an increased risk of HSR due to the absence of H2A in the premedication protocols for paclitaxel. Thus, in contrary to the existing literature on paclitaxel, our findings support the use of a premedication protocol without H2A.
Identifiants
pubmed: 37438439
doi: 10.1007/s00228-023-03536-x
pii: 10.1007/s00228-023-03536-x
doi:
Substances chimiques
Paclitaxel
P88XT4IS4D
Histamine
820484N8I3
Dexamethasone
7S5I7G3JQL
Ranitidine
884KT10YB7
Histamine Antagonists
0
Antineoplastic Agents, Phytogenic
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1229-1238Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Références
Picard M (2017) Management of hypersensitivity reactions to taxanes. Immunol Allergy Clin North Am 37:679–693. https://doi.org/10.1016/j.iac.2017.07.004
doi: 10.1016/j.iac.2017.07.004
pubmed: 28965634
Pellegrino B, Boggiani D, Tommasi C, Palli D, Musolino A (2017) Nab-paclitaxel after docetaxel hypersensitivity reaction: case report and literature review. Acta Biomed 88:329–333. https://doi.org/10.23750/abm.v88i3.6138
Kundranda MN, Niu J (2015) Albumin-bound paclitaxel in solid tumors: clinical development and future directions. Drug Des Devel Ther 9:3767–3777. https://doi.org/10.2147/DDDT.S88023
doi: 10.2147/DDDT.S88023
pubmed: 26244011
pmcid: 4521678
de Lemos ML, Waignein S, de Haan M (2016) Evidence-based practice in times of drug shortage. J Oncol Pharm Pract 22:566–570. https://doi.org/10.1177/1078155215589980
doi: 10.1177/1078155215589980
pubmed: 26044588
de Santi F, Beltrame FL, Hinton BT, Cerri PS, Sasso-Cerri E (2018) Reduced levels of stromal sex hormone-binding globulin and androgen receptor dysfunction in the sperm storage region of the rat epididymis. Reproduction 155:467–479. https://doi.org/10.1530/REP-18-0014
doi: 10.1530/REP-18-0014
pubmed: 29748247
Banerji A, Lax T, Guyer A et al (2014) Management of hypersensitivity reactions to carboplatin and paclitaxel in an outpatient oncology infusion center: a 5-year review. J Allergy Clin Immunol Pract 2:428–433. https://doi.org/10.1016/j.jaip.2014.04.010
doi: 10.1016/j.jaip.2014.04.010
pubmed: 25017531
Rezáč A, Jílek P, Rezáčová V, Škapinec P, Sedláková I, Tošner J, Špaček J (2013) Hypersensitivity reactions to carboplatin and paclitaxel – our five-years experiences. Ceska Gynekol 78:514–521
pubmed: 24372428
Pan EY, Merl MY, Lin K (2020) The impact of corticosteroid use during anti-PD1 treatment. J Oncol Pharm Pract 26:814–822. https://doi.org/10.1177/1078155219872786
doi: 10.1177/1078155219872786
pubmed: 31495293
Goromaru T, Morita N, Hase Y, Ochi Y, Shinohara Y, Takahashi K, Eto S (2011) Comparison of hypersensitivity to branded and generic paclitaxel injections in rats. Gan To Kagaku Ryoho 38:615–619
pubmed: 21498990
ANSM (2019) Rappel des médicaments à base de ranitidine en comprimé (Azantac et génériques): informations pour les patients et les professionnels de santé. https://ansm.sante.fr/actualites/rappel-des-medicaments-a-base-de-ranitidine-en-comprime-azantac-et-generiques-informations-pour-les-patients-et-les-professionnels-de-sante . Accessed 3 Dec 2022
ANSM (2018) Rappel de certains médicaments à base de valsartan: l’ANSM met à disposition des patients un numéro vert et un document d’information. https://ansm.sante.fr/actualites/rappel-de-certains-medicaments-a-base-de-valsartan-lansm-met-a-disposition-des-patients-un-numero-vert-et-un-document-dinformation . Accessed 3 Dec 2022
(2021) Risk of the presence of mutagenic azido impurities in losartan active substance. https://www.edqm.eu/en/news/risk-presence-mutagenic-azido-impurities-losartan-active-substance . Accessed 5 Dec 2021. Council of Europe, EDQM – European Directorate for the Quality of Medicines.
ANSM (2019) L’ANSM publie son rapport d’activité 2018. https://ansm.sante.fr/actualites/lansm-publie-son-rapport-dactivite-2018 . Accessed 3 Dec 2022
LEEM (2019) Ruptures des stocks des médicaments: les 10 classes thérapeutiques les plus touchées. https://www.leem.org/media/ruptures-des-stocks-des-medicaments-les-10-classes-therapeutiques-les-plus-touchees . Accessed 3 Dec 2022
Decool JP (2018) Pénuries de médicaments et de vaccins: renforcer l’éthique de santé publique dans la chaîne du médicament. http://www.senat.fr/rap/r17-737/r17-737.html
French League against cancer (2020) Shortages of medicines: increased risks for patients everywhere: focus on cancer. https://www.ligue-cancer.net/sites/default/files/docs/infographies_essentielles_en_anglais-.pdf
Auffret M, Tyvaert L, Laroche ML, Godet B, Peyron R, Guy C, Géniaux H, Pécriaux C, Baldin B, Béné J, Gautier S (2015) Drug shortage may have serious outcome: the French exemple of phenytoine. Ther Recreat J 70:377–380. https://doi.org/10.2515/therapie/2015018
doi: 10.2515/therapie/2015018
Fox ER, Sweet BV, Jensen V (2014) Drug shortages: a complex health care crisis. Mayo Clin Proc 89:361–373. https://doi.org/10.1016/j.mayocp.2013.11.014
doi: 10.1016/j.mayocp.2013.11.014
pubmed: 24582195
Official national Legifrance database (2016). LOI n° 2016–41 du 26 janvier 2016 de modernisation de notre système de santé - Article 151. https://www.legifrance.gouv.fr/loda/id/JORFTEXT000031912641/ . Accessed 7 Feb 2022
Académie Nationale de Pharmacie (2018) Indisponibilité des médicaments. https://www.acadpharm.org/dos_public/2018_06_20_AnP_RAPPORT_INDISPONIBILITE_MED_VF1.pdf
Bourneau-Martin D, Babin M, Grandvuillemin A, Mullet C, Salvo F, Singier A, Cellier M, Fresse A, de Canecaude C, Pietri T, Drablier G, Geniaux H, Lagarce L, Laroche ML, Briet M, Network F, of Regional Pharmacovigilance Centres, (2022) Adverse drug reaction related to drug shortage: A retrospective study on the French National pharmacovigilance Database. Br J Clin Pharmacol:n/a. https://doi.org/10.1111/bcp.15550
doi: 10.1111/bcp.15550
de Leon MCB, Bolla S, Greene B, Hutchinson L, Del Priore G (2013) Successful treatment with nab-paclitaxel after hypersensitivity reaction to paclitaxel and docetaxel. Gynecol Oncol Case Rep 5:70–71. https://doi.org/10.1016/j.gynor.2013.05.003
doi: 10.1016/j.gynor.2013.05.003
pubmed: 24371703
pmcid: 3862232
Picard M, Pur L, Caiado J, Giavina-Bianchi P, Galvão VR, Berlin ST, Campos SM, Matulonis UA, Castells MC (2016) Risk stratification and skin testing to guide re-exposure in taxane-induced hypersensitivity reactions. J Allergy Clin Immunol 137:1154-1164.e12. https://doi.org/10.1016/j.jaci.2015.10.039
doi: 10.1016/j.jaci.2015.10.039
pubmed: 26725998
Slimano F, Coliat P, Perotin JM, Vella-Boucaud J, Mongaret C, Bouché O (2016) Is antihistaminergic H2 really useful in prevention of hypersensitivity induced by paclitaxel? Support Care Cancer 24:4475–4477. https://doi.org/10.1007/s00520-016-3366-0
doi: 10.1007/s00520-016-3366-0
pubmed: 27480180
Berger MJ, Vargo C, Vincent M, Shaver K, Phillips G, Layman R, Macrae E, Mrozek E, Ramaswamy B, Wesolowski R, Shapiro CL, Lustberg MB (2015) Stopping paclitaxel premedication after two doses in patients not experiencing a previous infusion hypersensitivity reaction. Support Care Cancer 23:2019–2024. https://doi.org/10.1007/s00520-014-2556-x
doi: 10.1007/s00520-014-2556-x
pubmed: 25519756