[AF] Paroxetina y riesgo de suicidios

[Mariano Madurga]

Estimados colisteros:
  
A veces la suspicacia nos explica situaciones. Lo real, no imaginario, es el peso de la evidencia que se va a cumulando sobre este asunto: No creo que ha GSK le apetezca poner en la picota a su paroxetina. Esa es la aportación de la FV: ir desvelando lo que no se conocía, o no se exploraba, al existir indicio.
  
Como muestra la nota del 12 de mayo de la FDA en EE.UU.: http://www.fda.gov/medwatch/safety/2006/safety06.htm#paxil que viene a resumirse en esto:

“A recent meta-analysis conducted of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders. Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo. Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution. All of the reported events of suicidal behavior in the adult patients with MDD were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.

It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated. “

También hay que recordar la nota informativa del 10 de mayo al respecto de la Agencia Británica:
  
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2023719&ssTargetNodeId=221 
  

  
Mariano Madurga Sanz
Jefe de Servicio de Coordinación del SEFV
División de Farmacoepidemiología y Farmacovigilancia
Agencia Española de Medicamentos y Productos Sanitarios
28220-Majadahonda, Madrid
España

Telf: +34-91-596-7711. Fax: +34-91-596-7891
Correo-e: mmadurga en agemed.es
Internet: www.agemed.es