Maker of Schizophrenia Medicine Clarifies Risks

“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.” (Washington Post)

Risperdal had originally been marketed as an “atypical” antipsychotic, a term used to denote a new generation of antipsychotic medications without the severe side effects of the classical antipsychotic medicines like Haldol and Thorazine. But psychiatrists have been aware since we started using the drug that Risperdal’s freedom from those side effects only occurs at low doses which may be insufficient to control the symptoms for which it is prescribed. At effective doses, it behaves much like Haldol, including causing Haldol-like side effects. Psychiatrists have been lulled by the “atypical” label into preferentially prescribing this medication to the point where it has become the largest-selling antipsychotic medication. Furthermore, “atypicals” as a class have other metabolic and cardiovascular side effects that the classical antipsychotics did not. Partly because of the claims of safety, atypical antipsychotics have been used not only for the severe psychotic conditions such as schizophrenia and psychotic mania for which antipsychotic drugs were intended but also for a far broader variety of more benign indications than those for which psychiatrists would have dared prescribe the older medications. So the pool of patients potentially exposed to the complications of their use is vastly expanded. Finally, they have been indiscriminately used in children as well as adults, despite the lack of specific studies in the very different nervous systems of that age group demonstrating safety or effectiveness.