The Pharmaceutical Journal
Vol 271 No 7266 p314
13 September 2003

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Warning issued about venlafaxine use in children in United States

A warning that venlafaxine (Efexor) should not be used in children under 18 years has been issued in the United States. Manufacturer Wyeth has informed health professionals of the results of several studies showing that Efexor may be more likely to induce suicidal thoughts in children. At present there is no plan to issue similar advice in the United Kingdom.

The action follows a similar warning issued by the Medicines and Healthcare products Regulatory Agency, in June, surrounding the use of paroxetine (Seroxat) in those under 18 years (PJ, 14 June, p813). Trials reviewed by the MHRA showed that 3.4 per cent of those children in the study receiving paroxetine displayed potentially suicidal behaviour, compared with 1.2 per cent of those receiving placebo.

A spokesman for Wyeth confirmed that a warning had been issued in the US but insisted that this is part of the company’s routine procedures to maximise the accessibility of data as it becomes available.

A review of selective serotonin re-uptake inhibitors by the MHRA, in relation to their use in children and adolescents, is currently ongoing.