Two deaths unreported in Natrecor study
Wednesday, January 4, 2006
Johnson and Johnson has released information that two patients have died after taking the company's heart drug Natrecor. The deaths were not included in a report of a study the company released in October, and the company says they did not know of the two deaths when the original report was released. The company intends to reanalyze the data to see if these two deaths are of statistical significance to the drug's risk.
Natrecor is a drug used to treat acute heart failure and has been approved by the FDA since 2001. The FDA told the company a year ago to further explore the mortality data, in which the company said to have not found a statistically significant difference for mortality between the drug and a placebo.
A new report is said to be available in March about the possible health effects of the drug.
- "J&J says it missed 2 deaths in drug study" — , January 3, 2006
- "J&J says two deaths unreported in Natrecor study" — , January 3, 2006