Seriousness of adverse events: medical judgment is important
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7479.1405 (Published 09 December 2004) Cite this as: BMJ 2004;329:1405
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In their letter "Seriousness of adverse events: medical judgment is important", drug safety experts Javier Borja, Esther Donado & Mario Souto (1) reply to a previous letter of mine published in the BMJ (2). However, in contrast to what the authors suggest, my letter does not ask for a redefinition of the term "serious adverse drug reaction". Rather it cautions physicians not to consider the prophylactic antimalarial drug mefloquine as "well tolerated" just because no "serious" side-effects were observed in double-blinded trials. This is even more important since the same studies clearly prove the medication frequently causes "moderate" to "severe" (neuropsychiatric) adverse reactions.
As first pointed out in the BMJ in 1996 (3), a severe neuropsychiatric drug reaction from a prophylactic malaria medication might well have devastating consequences for travelers. While one might argue the risk of malaria could justify such risks, the better tolerance of the equally effective alternatives doxycycline or atovaquone-proguanil raises strong doubts over the use of mefloquine as a firstline prophylactic antimalarial drug.
(1) Borja J, Donada E, Souto M: Seriousness of adverse events: medical judgment is important. BMJ 2004;329:1405 (11 December), doi:10.1136/bmj.329.7479.1405.
(2) Frankenfeld C: "Serious" and "severe" adverse drug reactions need defining. BMJ 2004;329:573 (4 September), doi:10.1136/bmj.329.7465.573.
(3) Barrett PJ, Emmins PD, Clarke PD, Bradley DJ. BMJ 1996;313:525- 528 (31 August).
Competing interests: CF cooperates with the Coalition for Anti-malarial Drug Safety, a volunteer organisation that provides information and support to those who believe they have experienced side effects from anti-malarial drugs.
Competing interests: No competing interests
Re: Response to Christian Frankfenfeld
We acknowledge the response of Frankenfeld to our letter published in the issue of 11 December, in the Journal (1). In our opinion, if Frankenfeld's letter (2) did not ask for a redefinition of the term "serious adverse drug reaction", the title should be another.
Besides, when referring to the Council for International Organisations of Medical Sciences, Frankenfeld did not consider that in such definition clinical judgement is included (3). If Frankenfeld's intention was alert about cautions of serious side effects of mefloquine, his letter should be addressed to analyze these side effects and their seriousness.
Clear and precise language is of paramount importance in scientific (and human) communication.
1) Borja J, Donado E, Souto M. Serioussness of adverse events: medical judgement is important. Br Med J 2004; 329: 1405.
2) Frankenfeld C. "Serious" and "severe" adverse drug reactions need defining. Br Med J 2004; 239: 573.
3) Council for International Organisations of Medical Sciences. Current challenges in pharmacvovigilance: pragmatic approaches. Report of CIOMS Working Group V. Geneva: CIOMS, 2001.
Competing interests: None declared
Competing interests: No competing interests