European drug regulators revisit SSRIs, warn doctors on antidepressants

Pharma Marketletter, December, 2004

The issue of the safety of selective serotonin reuptake inhibitor antidepressants was the subject of an extraordinary meeting of the European Medicines Agency' scientific unit, the Committee for Medicinal Products for Human Use (CHMP) this month and has resulted in the recommendation of two actions.

At the request of the European Commission, the CHMP re-examined its April 22 opinion on paroxetine (GlaxoSmithKline's Paxil/Seroxat) in the light of additional information arising from newly-available observational studies. As already reported (Marketletter December 13), the UK's Medicines and Healthcare products Regulatory Agency has called for curbs on SSRIs, following an 18-month review of hundreds of clinical trials looking at the safety of this class of drug, with...