July 26, 2004

Risperdal increases warnings

Janssen Pharmaceutica Products, the maker of the atypical anti-psychotic Risperdal (risperidone), is revising its warnings after FDA claims that the company downplayed potential safety risks.

Although Janssen updated their warning labels in 2003 after a general FDA request to several drug companies, FDA officials maintained that Risperdal labels and promotional material did not accurately portray the risk of strokes, diabetes, and other complications for healthcare consumers. The company also allegedly made claims that their drug was safer than other available anti-psychotics.

In answer, the company recently released a two-page report to health care professionals, re-stating the potential risks for patients taking Risperdal.

In a federal lawsuit earlier this month, a doctor fingered the Janssen company in his general charge that children have been harmed and even killed by drugs that are inappropriately or over-aggresively marketed by pharmaceutical manufacturers.

For the full news story, see "Maker of Schizophrenia Medicine Clarifies Risks" (July 25, 2004) in the Washington Post (http://www.washingtonpost.com/)

For more information on the medication Risperdal and its potential side effects, see the Medications section (Risperdal) on the schizophrenia.com website.


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