Maker of Risperdal Clarifies Risks
This drug is sometimes given to those with autism with comorbid mental disorders.
The maker of a popular medicine for schizophrenia has notifieddoctors that it had minimized potentially fatal safety risks and had mademisleading claims about the drug in promotional materials. Janssen Pharmaceutica Products LP sent a two-page letter to healthcare professionals to clarify the risks of Risperdal, Carol Goodrich, aspokeswoman for the Johnson & Johnson subsidiary, said on Saturday.
The letter stems from a directive issued last year by the Food andDrug Administration, which told several makers of anti-psychotic drugs toupdate their product labels. Janssen complied in November 2003, but the FDA determined that thecompany’s promotional materials still minimized the risk of strokes,diabetes and other potentially fatal complications.
The agency also saidJanssen made misleading claims that the medication was safer in treatingmental illness than similar drugs. The Miami Herald reported on Saturday that several boys in Floridadeveloped lactating breasts after taking Risperdal. The drug, which is prescribed to more than 10 million peopleworldwide, was cited in a federal lawsuit filed earlier this month by adoctor who contends that children have been harmed and even killed by themisuse of drugs that he blames on the aggressive marketing by drugmanufacturers.
“The FDA did not think we had [initially] provided enoughinformation, so that is why further notification was done,” Goodrich said. Risperdal is the leading drug used to combat schizophrenia and othertypes of psychotic disorders, bringing Janssen about $2.1 billion in annualsales. The drug was first marketed about eight years ago