# \[e-drug\] Artesunate- and amodiaquine-associated extrapyramidal reactions **URL:** \ **Category:** e-drug\ **Created:** [November 24, 2012, 9:22pm UTC](https://talk.edrugplus.org/t/e-drug-artesunate-and-amodiaquine-associated-extrapyramidal-reactions/38197 "2012-11-24T21:22:57Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![myhr](https://avatars.discourse-cdn.com/v4/letter/m/f07891/32.png) [@myhr](https://talk.edrugplus.org/u/myhr)\ **Post date:** [November 24, 2012, 9:22pm UTC](https://talk.edrugplus.org/t/e-drug-artesunate-and-amodiaquine-associated-extrapyramidal-reactions/38197/1 "2012-11-24T21:22:57Z")
E-DRUG: Artesunate- and amodiaquine-associated extrapyramidal reactions --------------------------------------------------------------------- [Underreporting of adverse drug reactions is common and in particular in countries where diseases such as malaria are prevalent. It is therefore worth noting that an association of EPS with combination therapy with amodiaquine and artesunate that has been established, and even in low doses. As WHO has now established spontaneous reporting system in many of the countries with malaria, E-druggers are encouraged to report ADRs to further verify this association as well as other adverse reactions to antimalarials. KM] McEwen J\*. Artesunate- and amodiaquine-associated extrapyramidal reactions: a series of 49 cases in VigiBaseT. Drug Saf 2012 Aug 1;35(8):667-75. doi: 10.2165/11599860-000000000-00000. \* Discipline of Pharmacy, University of Canberra, Canberra, ACT, Australia [http://adisonline.com/drugsafety/Abstract/2012/35080/Artesunate\_\_and\_Amodiaq](http://adisonline.com/drugsafety/Abstract/2012/35080/Artesunate__and_Amodiaq) uine\_Associated.7.aspx Abstract BACKGROUND: Acute extrapyramidal reactions have been attributed to amodiaquine. They may be anticipated with the widely-used combination antimalarial artesunate with amodiaquine, but the association is very poorly documented. OBJECTIVE: The aim of the study was to identify individual case safety reports in the Uppsala Monitoring Centre's VigibaseT database associating the use of the combination of artesunate and amodiaquine with extrapyramidal adverse reactions and to characterize the clinical features in those reports. METHODS: Reports of adverse reactions to the combination use of artesunate or dihydroartemisinin and amodiaquine entered into VigibaseT up to 15 February 2011 were identified. Reports with a causality grading of 'Unlikely' and probable duplicates of reports were excluded. Reports that included at least one MedDRAR Preferred Term strongly suggestive of an extrapyramidal reaction were subject to further detailed analysis. RESULTS: Forty-three reports in adults and six reports in children were identified as associating the use of artesunate with amodiaquine, either as separate co-packaged or fixed-combination products, with extrapyramidal reactions. More than half (57%) of the adults had an onset of the reaction within 48 hours of starting treatment. Almost equal numbers of male and female adult patients were reported - 67% were aged between 14 and 30 years. The most commonly implicated daily dose was amodiaquine base 600 mg and artesunate 200 mg, but lower doses were implicated in some adult patients. Identification of very long delays in some reports reaching VigibaseT was an unexpected observation. CONCLUSIONS: This case series supports an association of the use of artesunate and amodiaquine as combination antimalarial therapy with acute extrapyramidal reactions. The reactions occurred with recommended, and in some instances reduced, daily doses. Extrapyramidal reactions are unpleasant and frightening and the association warrants being more clearly recorded in official treatment guidelines and Summary of Product Characteristics documents. PMID: 22788236 Correspondence: Dr John McEwen, 253 La Perouse Street, Red Hill, ACT 2603 Australia.