J&J's Scios reports new Natrecor deaths

Johnson & Johnson subsidiary Scios has submitted an interim report to the US Food & Drug Administration, and other relevant international regulatory authorities, on an ongoing expanded analysis of a three-year-old exploratory health outcomes study (the PROACTION trial) comparing treatment with Natrecor (nesiritide) to placebo. The report contains two additional deaths that had occurred within 30 days after treatment with the drug but which had not been initially reported to the firm.

The two new cases, which bring the number of deaths associated with Natrecor to seven, were not included in a report on the PROACTION study that was published in the Journal of Emergency Medicine, October 2005.

In January 2005, Scios agreed with the FDA to conduct an expanded analysis of PROACTION to evaluate all-cause mortality through 180 days following treatment with Natrecor or placebo. This expanded analysis goes beyond the study's original protocol-defined 30-day mortality follow-up period. It was in the course of this analysis that the two additional deaths were identified.