July 25, 2004
Warning on Schizophrenia Drug
The maker of a popular medicine for schizophrenia has notified doctors that it minimized potentially fatal safety risks and made misleading claims about the drug in promotional materials.
The company, Janssen Pharmaceutica Products, sent a two-page letter to health care workers this week to clarify the risks of the drug, Risperdal, Carol Goodrich, a spokeswoman for Janssen, a Johnson & Johnson subsidiary, said Saturday.
The letter stems from a directive issued last year by the Food and Drug Administration, which told several makers of antipsychotic drugs to update their product labels.
Janssen complied in November 2003, but the agency determined that the company's promotional materials still minimized the risk of strokes, diabetes and other potentially fatal complications. The agency also said Janssen had made misleading claims that the medication was safer than similar drugs.
Ms. Goodrich said the agency wanted the company to provide more information, ''so that is why further notification was done.''
The Miami Herald reported on Saturday that a handful of boys in Florida developed lactating breasts after taking Risperdal.
The drug, which is prescribed to more than 10 million people worldwide, was cited in a federal lawsuit filed earlier this month by a doctor who claimed that children were harmed and even killed by the misuse of drugs he attributed to aggressive marketing by drug manufacturers.
Risperdal is the leading drug used to combat schizophrenia and other psychotic disorders, and earns Janssen about $2.1 billion in annual sales. The drug was first marketed about eight years ago.
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