GlaxoSmithKline has agreed to disclose information on all clinical studies of its drugs to settle a lawsuit that accused it of withholding negative information about the antidepressant Paxil, the New York Attorney General's office has said.
GlaxoSmithKline has agreed to pay $2.5 million (€2.08 million) and will register the results of clinical trials, detailing safety and drug effectiveness, for all studies done after December 27th, 2000, and relevant earlier studies, New York Attorney General Mr Eliot Spitzer said.
Mr Spitzer, in a lawsuit filed in June, had accused GlaxoSmithKline of concealing studies that showed Paxil may not work when used to treat children and could lead to suicidal behavior.
The lawsuit said GlaxoSmithKline had conducted at least five studies on the use of Paxil, which is facing generic competition after generating worldwide sales of $3 billion in 2003, in children and adolescents, but released only one of the studies.
The company said the charges are "unfounded" and said it settled to avoid costly and time-consuming litigation.
GlaxoSmithKline on June 18 said it would reveal details of its clinical studies, but the settlement gives the company a formal timetable to disclose those studies, a spokeswoman said. - (Reuters)
