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adverse

16:54 Nov 9, 2009

English to French translations [PRO]
Medical - Medical (general)

English term or phrase: adverse

En anglais, "adverse reaction" doit selon l'EMEA être utilisé lorsqu'il y a un lien causal avec l'utilisation d'un médicament.
"adverse event", toujours selon l'EMEA, doit l'être lorsque le rapport avec l'utilisation du médicament n'est pas (encore) établi.
Faites-vous une différence en français ou bien traduisez-vous les 2 expressions indifféremment par "effets indésirables"?
Ceci est une question générale juste à titre d'info car, en ce qui me concerne, j'ai à chaque fois une hésitation.
Merci d'avance pour votre opinion

Veronique Parente KudoZ activity Questions: 27 (1 open) (1 without valid answers) (1 closed without grading) Answers: 94 Netherlands
Local time: 14:59

Summary of answers provided

4 +4

adverse reaction=effet indésirable; événement indésirable=adverse event

Helen Genevier

4 +1

indésirable ou adverse

Drmanu49

Summary of reference entries provided

MEDECINE VS. CLINICAL PHARMA

Dr D Jones

Discussion entries: 1

Answers

22 mins confidence:

peer agreement (net): +1

indésirable ou adverse

Explanation:
mais secondaire n'est pas adéquate comme traduction.

Drmanu49
France
Local time: 14:59
Specializes in field
Native speaker of:

English,

French
PRO pts in category: 2073

33 mins confidence:

peer agreement (net): +4

adverse reaction=effet indésirable; événement indésirable=adverse event

Explanation:
The EMEA makes the same distinction in French as in English between effet indésirable > adverse reaction and événement indésirable > adverse event.

bilingual display of the definitions: http://eur-lex.europa.eu/Notice.do?mode=dbl&lang=en&ihmlang=...

(m) "adverse event": any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment;
m) "événement indésirable": toute manifestation nocive chez un patient ou un participant à un essai clinique traité par un médicament, et qui n'est pas nécessairement liée à ce traitement;
(n) "adverse reaction": all untoward and unintended responses to an investigational medicinal product related to any dose administered;
n) "effet indésirable": toute réaction nocive et non désirée à un médicament expérimental, quelle que soit la dose administrée;

In more general documentation adverse effects can be used for effets indésirables, but not when talking about pharmacovigilance, reporting and causality.
Great multilingual ref here http://www.bvs.org.ar/pdf/seguridadpaciente.pdf

Helen Genevier
France
Local time: 14:59
Specializes in field
Native speaker of:

English
PRO pts in category: 8

Reference comments

9 mins

Reference: MEDECINE VS. CLINICAL PHARMA

Reference information:
It's a question of pharma versus medical terminology - In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect, and may result from an unsuitable or incorrect dosage or procedure, which could be due to medical error. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects only occur only when starting, increasing or discontinuing a treatment. Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause medical complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen.

The harmful outcome is usually indicated by some result such as morbidity, mortality, alteration in body weight, levels of enzymes, loss of function, or as a pathological change detected at the microscopic, macroscopic or physiological level. It may also be indicated by symptoms reported by a patient. Adverse effects may cause a reversible or irreversible change, including an increase or decrease in the susceptibility of the individual to other chemicals, foods, or procedures, such as drug interactions.

In clinical trials, a distinction is made between adverse events (AEs) and serious adverse events (SAEs). Generally, any event which causes death, permanent damage, birth defects, or requires hospitalization is considered an SAE. [1] The results of these trials are often included in the labeling of the medication to provide information both for patients and the prescribing physicians.

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Note added at 23 mins (2009-11-09 17:18:41 GMT)
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C'est donc la même chise l'uen étant un terme phrama et l'autre terme médical - mais pareil quoi quand même

Dr D Jones
France
Specializes in field
Native speaker of:

English
PRO pts in category: 203

Note to reference poster

Asker: Ok merci, c'est bien la définition courante d'un effet secondaire et la traduction de "adverse effect" ne pose pas de problème. Ma question est quid? lorsqu'on rencontre "adverse event" et "adverse reaction"

Asker: Tout à fait d'accord avec vous

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