FDA Releases Memo About Vioxx

Vioxx Might Have Caused 27,785 Heart Attacks and Deaths

In early November 2004, the FDA published a September 30 2004 Memorandum written by Dr. David J. Graham, an FDA researcher, to report about a study that examined whether the risk of serious coronary heart disease was increased among patients treated with rofecoxib (Vioxx). The underlying study was conducted by Dr. Graham together with Kaiser Permanente and the results were initially reported in August 2004.

Based on a sample of patient records, the September 2004 memo concluded that people taking Vioxx were more likely to have heart attacks or die from sudden cardiac arrest than people taking a competing painkiller, Celebrex. The study further speculated that Vioxx might have contributed to 27,785 heart attacks and deaths in patients taking Vioxx from 1999 through 2003. That figure is a projection based on findings from an analysis of a database of patients of Kaiser Permanente, a health maintenance organization. The heart attacks could possibly have been avoided if those same patients took Celebrex instead of Vioxx, since people taking a high dose of Vioxx were 3.69 times as likely to have a serious cardiac event as people taking Celebrex.

Read more on our Vioxx Information Page >>