Psychiatric News August 20, 2004
Volume 39 Number 16
© 2004 American Psychiatric Association
p. 28
Janssen Clarifies Risperdal Risks
Last year the Food and Drug Administration (FDA) told several makers of
antipsychotic drugs to update their product labels with regard to serious
risks associated with taking the drugs. Janssen Pharmaceutica Products LP,
which makes Risperdal, complied in November 2003. But the FDA determined that
the company's promotional materials still minimized the risks of diabetes and
other potentially fatal complications. The FDA also said that Janssen made
misleading claims that the medication was safer in treating mental illness
than other similar drugs.
In response, Janssen sent health care providers a letter dated July 21
providing "important corrective information about Risperdal relating to
hyperglycemia and diabetes mellitus."
The letter is posted at
<http://psychrights.org/drugs/risperidonecorrectionocr.pdf>.
More information can be obtained by calling (800) JANSSEN. 
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