alks: Now what?
J&J's Risperdal Raises Tumor Issue
By LEILA ABBOUD
Staff Reporter of THE WALL STREET JOURNAL
June 17, 2005; Page A3
Government researchers combing through a database of adverse drug reactions in patients found a higher incidence of benign tumors in the pituitary gland among patients taking Johnson & Johnson's antipsychotic Risperdal than for similar drugs.
The finding is preliminary, and doesn't prove whether the tumors were caused by the drugs or other factors. But it is notable because Risperdal appears different from other antipsychotics, said Paul Seligman, who directs the Food and Drug Administration office responsible for postmarketing drug surveillance. "When we see these kinds of differences among products it raises the question of whether further detailed analysis needs to be done," said Dr. Seligman. The study hasn't yet been published and will be presented at a University of Pittsburgh conference today.
A Johnson & Johnson spokesman said the company would be analyzing the data to determine if further study is required.
Risperdal is one of the most widely prescribed antipsychotics, which are used primarily to treat schizophrenia and bipolar disorder. It was the New Brunswick, N.J., company's second-biggest-selling drug with world-wide sales of $3.1 billion last year.
Risperdal jostles for market share with several other major drugs in the so-called atypical antipsychotic class, including Eli Lilly & Co.'s Zyprexa, AstraZeneca PLC's Seroquel and Abilify, marketed by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. All told, such drugs had world-wide sales of $14 billion last year, according to IMS Health Inc., and their use has expanded to include children with severe behavioral problems, elderly people with dementia, and people with other psychiatric disorders.
Side-effect issues have a big impact on sales in this highly competitive class. Zyprexa's market share has slipped six percentage points over the past year over concerns about weight gain and diabetes; the FDA in 2003 required all the drugs to carry warnings about weight gain and diabetes.
The FDA researchers started looking at Risperdal after noticing reports of men and children who were producing breast milk. Tumors can cause the pituitary to secrete too much of a hormone called prolactin, whose main function is to stimulate breast milk production during pregnancy. High prolactin levels can also cause people to stop menstruating and develop infertility or impotence. Patients with pituitary tumors are usually treated with medications, and sometimes radiation or surgery.
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%, occurred in patients taking antipsychotics. Forty-eight reports of pituitary tumors were reported in patients taking Risperdal, six in patients taking Zyprexa, four associated with Pfizer Inc.'s Geodon, and one with Seroquel. Novartis AG's Clozaril, which is also available as a generic clozapine, had three reports, while haloperidol, an older generic antipsychotic, had eight reports. Abilify had zero cases, but hasn't been on the market for as long as the other drugs.
Ana Szarfman, a FDA medical officer and lead author of the study, said this kind of study can't reveal how common the side effect is because doctors don't report all adverse reactions to the government.
"Patients should not stop taking their medications before talking to their doctor about all the risks and benefits," said P. Murali Doraiswamy, a psychiatrist at Duke University and co-author on the study. He has consulted for several manufacturers of antipsychotic drugs.
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