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Drug Safety

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01.01.2013 | Correspondence

Author’s Reply to Bompart: “Artesunate- and Amodiaquine-Associated Extrapyramidal Reactions: Information Gained from an African-Based Risk Management Plan”

verfasst von: John McEwen

Erschienen in: Drug Safety | Ausgabe 1/2013

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Excerpt

To restrict postmarketing surveillance to a “Potential risk: to be quantified in large-scale studies” [1] is unusual as it excludes routine pharmacovigilance, no matter how limited that may be perceived. My study [2] showed that a less-dismissive attitude to Sub-Saharan pharmacovigilance is warranted. …

Sanofi aventis. The artesunate amodiaquine fixed-dose combination (ASAQ) risk management plan, February, 2011. http://www.who.int/selection_medicines/committees/expert/18/applications/RiskManagementPlan.pdf. Accessed 24 Nov 2012.

McEwen J. Artesunate- and amodiaquine-associated extrapyramidal reactions: a series of 49 cases in VigiBase™. Drug Saf. 2012;35(8):667–75.PubMed

WHO Pharmaceuticals. Newsletter. 2010;4:20. http://www.who.int/medicines/publications/newsletter/2010news_4.pdf. Accessed 2012 Nov 29.

WHO Pharmaceuticals. Newsletter. 2011;3:12. http://www.who.int/medicines/publications/PharmNew3_2011.pdf. Accessed 2012 Nov 29.

Bompart F. Artesunate- and amodiaquine-associated extrapyramidal reactions: information gained from an African-based risk management plan [letter]. Drug Saf. 2013. doi:10.1007/s40264-012-0010-x

Titel: Author’s Reply to Bompart: “Artesunate- and Amodiaquine-Associated Extrapyramidal Reactions: Information Gained from an African-Based Risk Management Plan”
verfasst von: John McEwen
Publikationsdatum: 01.01.2013
Verlag: Springer International Publishing AG
Erschienen in: Drug Safety / Ausgabe 1/2013
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-012-0011-9

Springer Medizin

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