UNITED STATES: Drug companies withheld data on side effects

Rachel Evans

On February 2, a US Food and Drug Agency (FDA) advisory committee warned doctors to use great caution in prescribing anti-depressant drugs to children, citing an increased risk of suicide among those taking the drugs.

The FDA is under pressure after the British Medicines and Healthcare Products Regulatory Agency (MHRA) in December banned the prescription of all selective serotonin reuptake inhibitors (SSRIs), other than Prozac, to children. However, the MHRA noted that Prozac only helps one child in 10. There are an estimated 50,000 children on anti-psychotic drugs in Britain.

The ban is blow to giant pharmaceutical corporations, which have made billions from the sale of the drugs and have withheld negative anti-depressant trial results from US and British regulators.

According to December 10 Guardian, the MHRA found that the drug companies' own trial results revealed that the drugs were associated with suicidal behaviour in children. GlaxoSmithKline did not submit negative data to the MHRA on how Seroxat affected children for seven years. Data was also gathered in 1996 during a trial of Lustral, manufactured by Pfizer, showed that 9% of depressed children on the drug became suicidal.

The Guardian reported that trials on children using all available SSRIs have not been carried out, but those that have been completed "show a worrying increase in suicidal behaviour among those on SSRIs compared with those given a placebo (sugar pill)".

According to the FDA's Psychopharmacologic Drugs Advisory Committee, a preliminary review of data provided by the drugs corporations revealed an increased risk of suicide among users of paroxetine (produced by GlaxoSmithKline as Paxil), sertraline (Pfizer's Zoloft), venlafaxine (Wyeth's Effexor) and citalopram (Forest's Celexa).

The FDA expects to re-analyse the data by mid-year and then convene another advisory committee to discuss definite regulatory actions for antidepressant drugs.

From Green Left Weekly, February 25, 2004.

Visit the Green Left Weekly home page.

From GLW issue 572