New York sues Glaxo over Paxil’s use in children

British drug giant accused of consumer fraud,

misrepresenting data about Paxil’s efficacy


NEW YORK, JUNE 3: The New York state attorney general on Wednesday accused the British drug giant GlaxoSmithKline of consumer fraud, asserting that the company had withheld negative information and misrepresented data about the efficacy and safety of prescribing the antidepressant drug Paxil to children.

The civil lawsuit, filed in New York State Supreme Court, states that beginning in 1999, Glaxo suppressed the results of four studies that did not find the drug effective in treating children and adolescents and that suggested a possible increased risk of suicidal thinking and acts.

‘‘By concealing critically important scientific studies on Paxil, GlaxoSmithKline impaired doctors’ ability to make the  appropriate prescribing decision for their patients and may have jeopardised their health and safety,’’ the attorney general, Eliot Spitzer, said in a statement.

Paxil has been approved by the US Food and Drug Administration for the treatment of depression in adults. Prozac, which is manufactured by Eli Lilly & Co, is the only antidepressant that has been approved to treat depression in children. However, doctors have professional discretion to prescribe Paxil for treatment in children, a so-called off-label use. Doctors routinely recommend antidepressants for children suffering from depression and other psychological disorders.

A recent study sponsored by the National Institute of Mental Health found that Prozac was more effective than psychotherapy in treating depression among teenagers and that the two treatments together yielded the best results.

In April, a European Union advisory panel recommended that Glaxo strengthen warnings about severe withdrawal symptoms when patients stop taking Paxil.

European Union regulators also recommended that Paxil not be given to children because clinical trials had found the drug to be associated with increased risk of suicidal behaviour and hostility.

In the United States, the Food and Drug Administration has recommended caution in prescribing Paxil in children and adolescents for the treatment of major depressive disorder, and is currently conducting an analysis of the data related to the use of Paxil in children and adolescents and the possibility of increased suicidal thoughts. A Glaxo spokeswoman, Mary Anne Rhyne, told The Associated Press that the company ‘‘has acted responsibly in conducting the studies in pediatric patients and disseminating results,’’ adding, ‘‘All of our studies have been made available to the Food and Drug Administration and regulators worldwide.’’

Last Updated 6/25/04