Schizophrenia Drug Maker Clarifies Risks

Monday, July 26th 2004, 10:50 am

By: News On 6

TRENTON, N.J. (AP) _ 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.

Janssen Pharmaceutica Products sent a two-page letter to the health care community this past week to clarify the risks of Risperdal, Carol Goodrich, a spokeswoman for the 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 anti-psychotic drugs to update their product labels.

Janssen complied in November 2003, but the FDA determined that the company's promotional materials still minimized the risk of strokes, diabetes and other potentially fatal complications. The agency also said Janssen made misleading claims that the medication was safer in treating mental illness than similar drugs.

The Miami Herald reported 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 claims children have been harmed and even killed by the misuse of drugs he blames on aggressive marketing by drug manufacturers.

``The FDA did not think we had (initially) provided enough information, so that is why further notification was done,'' Goodrich said.

Risperdal is the leading drug used to combat schizophrenia and other types of psychotic disorders, earning Janssen about $2.1 billion in annual sales. The drug was first marketed about eight years ago.