NEW YORK (Reuters) - Government researchers searching a database of adverse drug reactions found a higher incidence of benign pituitary gland tumors in patients taking Johnson & Johnson's popular antipsychotic Risperdal than for similar drugs, a newspaper report said Friday.
The preliminary finding does not prove whether the tumors were caused by the drugs or other factors, the Wall Street Journal said.
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</SCRIPT> But it is notable as Risperdal appears different from other antipsychotics, Paul Seligman, who directs the Food and Drug Administration office responsible for postmarketing drug surveillance, told the Journal.
"When we see these kinds of differences among products, it raises the question of whether further detailed analysis needs to be done," Seligman told the newspaper.
The study is to be presented at a University of Pittsburgh conference later Friday.
A Johnson & Johnson (down $0.05 to $66.30, Research) spokesman said the company would be analyzing the data to determine if further study of its drug is necessary.
Risperdal, widely prescribed for schizophrenia and bipolar disorder, is J&J's second-biggest-selling drug, with global sales of $3.1 billion last year.
The FDA researchers started looking at Risperdal after noticing reports of men and children who were producing breast milk -- a sign of tumors in the pituitary gland, the report said.
The researchers analyzed 2.5 million adverse events reported by doctors, patients and individuals since 1968.
Of the 307 reports of pituitary tumors, 64, or 21 percent, occurred in patients taking antipsychotics. Forty-eight reports of pituitary tumors involved patients taking Risperdal, compared with six in patients taking Eli Lilly & Co's (up $1.00 to $58.36, Research) Zyprexa and four associated with Pfizer Inc.'s (up $0.17 to $28.60, Research) Geodon, the newspaper said.
