GSK facing lawsuit over drug for children

British pharmaceuticals giant GlaxoSmithKline was hit with a multi-million pound lawsuit today after allegedly misleading doctors about the safety of an anti-depressant drug for children.

The lawsuit, filed by New York State Attorney General Eliot Spitzer, accused the company of “concealing important information about the safety and efficacy of an anti-depressant drug”.

It is claimed the company withheld the results of medical studies about the drug, Paxil.

Paxil has not been cleared by US authorities for use in treating children with depression, but doctors can prescribe it at their discretion.

According to a statement from the Attorney General’s office, GlaxoSmithKline “engaged in repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil …”

The lawsuit was filed in New York State Supreme Court in Manhattan.

It alleges GlaxoSmithKline conducted at least five studies on the use of Paxil in children and adolescents.

But the company only published and disseminated one of these studies, which showed mixed results on efficacy, the lawsuit alleges.

Mr Spitzer said: “Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients.

“By concealing critically important scientific studies on Paxil, GSK impaired doctors’ ability to make the appropriate prescribing decision for their patients and may have jeopardised their health and safety.”

The lawsuit seeks disgorgement of all profits obtained by GSK as a result of the conduct alleged in the suit.

According to the Attorney General, more than two million prescriptions for Paxil were written for children and adolescents in the US in 2002.

Nearly 900,000 of these prescriptions were for youngsters whose primary diagnosis was a mood disorder, the most common of which is depression.

This translated into US sales of about $55m (€45m).