U.S. regulators have warned Johnson & Johnson unit Janssen Pharmaceutica that a letter sent to doctors about its Risperdal drug to treat schizophrenia and bipolar mania is misleading. In a warning disclosed on Tuesday, the Food and Drug Administration told Janssen that its November letter failed to disclose information added to Risperdal’s labeling about excess blood sugar and diabetes and minimized the risk of serious events including coma and even death. The FDA also said the letter fails to recommend regular testing for diabetes and “misleadingly claims that Risperdal is safer than other atypical antipsychotics.”
Dr. John Grohol is the CEO and founder of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.Like this author?
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Last reviewed: By John M. Grohol, Psy.D. on 27 Apr 2004
Published on PsychCentral.com. All rights reserved.
Grohol, J. (2004). J&J Warned on Claims About Antipsychotic Drug. Psych Central. Retrieved on May 25, 2012, from http://psychcentral.com/blog/archives/2004/04/27/jj-warned-on-claims-about-antipsychotic-drug/
