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Titolo:
ADVERSE EVENT RECORDING IN NEW ANTIDEPRES SANTS
Autore:
STEVENS I; GAERTNER HJ;
Indirizzi:
UNIV TUBINGEN,KLIN PSYCHIAT & PSYCHOTHERAPIE,OSIANDERSTR 22 D-72076 TUBINGEN GERMANY
Titolo Testata:
Nervenheilkunde
fascicolo: 2, volume: 15, anno: 1996,
pagine: 85 - 91
SICI:
0722-1541(1996)15:2<85:AERINA>2.0.ZU;2-2
Fonte:
ISI
Lingua:
GER
Soggetto:
SEROTONIN SYNDROME; FLUOXETINE; MOCLOBEMIDE;
Keywords:
ADVERSE EVENTS; SSRI; MAO-I; EVENT RECORDING;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
22
Recensione:
Indirizzi per estratti:
Citazione:
I. Stevens e H.J. Gaertner, "ADVERSE EVENT RECORDING IN NEW ANTIDEPRES SANTS", Nervenheilkunde, 15(2), 1996, pp. 85-91

Abstract

In Germany we have two systems of adverse event reporting is dependent on reporting practice and only starts after marketing the new drug, event recording is regulary used in clinical studies and means documentation of any detrimental change in the patients' condition during thetrial - intensity, seriousness, outcome and causality assessment to test drug are then evaluated. Frequency and severity of adverse events are established with different accuracy by the two methods; a side effect profile is just clearly defined by event recording when placebo controlled studies are done. Not expected or very rare adverse events are difficult to relate to the drug, frequent and harmless side effects are underestimated by spontaneous recording due to reporting fatigue. The new antidepressant drugs serve as example to illustrate debated results of reporting systems focussing on suicidality, restlessness and agitation, sexual dysfunction, headache and malaise.

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Documento generato il 25/01/20 alle ore 18:38:54