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-April 27, 2004
The FDA warned Risperdal maker Janssen Pharmaceuticals, a unit of Johnson & Johnson that its November 2003 letter issued to doctors was misleading. According to the FDA, the letter failed to disclose information added to Risperdal's labeling regarding excess blood sugar and diabetes risks, in addition to minimizing the risk of serious events like death and coma.
Also excluded from the letter was the recommendation for regular testing for diabetes. The company made misleading claims indicating Risperdal is a safer choice than competing atypical antipsychotics. Janssen is to stop any distribution of promotions containing similar messages and to then issue more accurate and complete information to the recipients of the former letter.
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