Company 'held back' data on SSRI anti-depressants for children

February 8, 2004

The Guardian newspaper has reported that British manufacturers of the SSRI antidepressant, Seroxat, that was last year banned for children, knew in 1998 that it was not effective.

The newspaper said that the company deliberately avoided publishing the full data because of the risk to their lucrative adult market. This was according to a leaked internal document.

The Guardian wrote that a position paper dated October 1998 shows that managers at SmithKline Beecham - now GlaxoSmithKline (GSK) - were concerned at the commercial implications of two clinical trials in which their drug Seroxat was given to children and adolescents with major depression.

However, Alastair Benbow, GSK's head of European clinical psychiatry, was quoted as saying that the document "draws inappropriate conclusions and it is inconsistent with the facts".

Meanwhile the British Medical Journal reported that in the United States scientific advisers to the Food and Drug Administration urged the agency to warn that SSRIs may increase the risk of suicidal thinking or behaviour among children and teenagers.

The BMJ reported that experts weighed the official presentations of uncertain scientific data against powerful emotional testimony from dozens of families whose children have killed themselves or others after taking SSRIs — a class including fluoxetine (Prozac), sertraline (Zoloft), and paroxetine (Paxil, Seroxat).

The advisers also decided to recommend "stronger warnings" about the suicide risks.

In 2002 almost 11 million prescriptions of selective serotonin reuptake inhibitors were written for people under 18, including more than five million for sertraline and paroxetine—neither of which are approved for children in the United States.

See also:
Dec, 2003: Medicines and Healthcare products Regulatory Agency's advice on SSRIs and children sent to psychiatrists and other mental health professionals (pdf)
Dec 14, 2003: Agency rules that SSRIs should not be prescribed for children

Add your comments
What do you think? Email your comments on the above
article to the editor using the form below. Selected comments will be displayed.

© 2001-7  Psychminded Limited. All rights reserved