Magazine article Clinical Psychiatry News

Risperidone Use Linked to Pituitary Tumors

Magazine article Clinical Psychiatry News

Risperidone Use Linked to Pituitary Tumors

Article excerpt

PITTSBURGH -- Treatment with the atypical antipsychotic drug risperidone was associated with an unusually high number of reports of pituitary tumors in an analysis done by the Food and Drug Administration of more than 2.5 million records in its Adverse Event Reporting System.

But the finding that 48 patients treated with risperidone (Risperdal) developed pituitary tumors is currently considered too preliminary to warrant any change in the use of risperidone or other atypical antipsychotic drugs, or to prompt physicians to systematically look for indications of hyperprolactinemia or pituitary tumors in patients treated with these drugs, commented Dr. Paul Seligman, director of the FDA office responsible for postmarketing surveillance.

"There were a relatively small number of reports, compared with the millions of patients on these drugs," he said in an interview. "It's too early to make conclusions about changing physician practice or to recommend choosing one drug over another." The next step the FDA will take is to review all of the adverse-event reports in detail, and then decide if any drug labeling needs changing or if alerts are needed, said Dr. Seligman, director of the FDA's Office of Pharmacoepidemiology and Statistical Sciences.

"Just based on the raw counts of reports, one should not conclude that risperidone is worse than all other antipsychotics," said Dr. P. Murali Doraiswamy, who presented the results in a poster at the Sixth International Conference on Bipolar Disorder. "The rank order of these drugs can vary slightly, depending on what one uses as a denominator. There are big differences in prescription number, and risperidone is expected to be associated with more reports because of its higher prescription number," added Dr. Doraiswamy, head of the division of biological psychiatry at Duke University in Durham, N.C.

The link between atypical antipsychotic drugs and pituitary tumors was found by a method called "data mining," in which a disproportionality analysis is done on the entire Adverse Event Reporting database that's maintained by the FDA. In fact, the current report was presented more to showcase the data-mining technique rather than to focus on a potential problem with risperidone and other drugs in its class, said Dr. Seligman. Similar analyses are currently being done to examine possible adverse events triggered by several other drugs and drug classes, he said in an interview.

The FDA's attention turned to atypical antipsychotics and pituitary tumors following prior reports that suggested that 25%-60% of people treated with certain antipsychotics have abnormal prolactin levels. Also, three prior case reports linked risperidone with growth of a prolactinoma, and a growing number of reports sent to the FDA have involved hyperprolactinemia and pituitary tumors in patients treated with atypical antipsychotics. …

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