This action follows the warning letters sent by Johnson & Johnson in April 2003, alerting physicians about Risperdal’s link to an elevated risk of stroke in elderly patients. At the time, the company had received 37 reports of stroke or stroke-like events, including 16 deaths, among Risperdal patients.
there were 11 sudden cardiac deaths in those receiving drugs compared with seven sudden cardiac deaths over 10,000 person-years of observation.