Suicide risk warning for children now extended by CSM to cover venlafaxine
Venlafaxine (Efexor, Efexor XL) should not be used in children and adolescents under the age of 18 years, the Committee on Safety of Medicines has warned. The advice comes after new safety concerns surfaced linking use of the drug with suicidal behaviour in this age group of patients.
Data from two clinical trials comparing venlafaxine, a serotonin and
noradrenaline reuptake inhibitor, with placebo reveal that venlafaxine
is not effective for the treatment of depression in children and that
it is associated with an increase in harmful outcomes including hostility,
suicidal thoughts and self-harm. Although there were no successful suicides
during the trials, there were three suicide attempts among the children
and adolescents treated with venlafaxine but none in the group given
placebo (the trials involved 361 patients).
Professor Gordon Duff, CSM chairman, said: “Efexor is already contraindicated
in those under 18 years, but we do know that it is used in this age group
outside its licensed indications. Young people under 18 years currently
taking Efexor should consult their doctor for advice.”
Wyeth, manufacturer of Efexor estimates that 3,000 patients under 18
years have been treated with venlafaxine in the past year.
The CSM has reminded prescribers that venlafaxine should not be stopped
suddenly. The dose should be reduced gradually over at least two weeks
and the patient monitored to minimise risk of withdrawal reactions. A
letter detailing the new advice has been sent to health professionals.
Similar advice was issued by the CSM in June about the use
of paroxetine (Seroxat) in young patients (PJ, 14 June, p813). |
