The maker of a popular medicine for schizophrenia has notified doctors that it had minimized potentially fatal safety risks and had made misleading claims about the drug in promotional materials.
Janssen Pharmaceutica Products LP sent a two-page letter to health care professionals to clarify the risks of Risperdal, Carol Goodrich, a spokeswoman for the Johnson & Johnson subsidiary, said on 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 on Saturday that several 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 contends that children have been harmed and even killed by the misuse of drugs that he blames on the 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, bringing Janssen about $2.1 billion in annual sales. The drug was first marketed about eight years ago.