F.D.A. Releases Memo on Vioxx

November 3, 2004

By BLOOMBERG NEWS

Providing details from a report it had described broadly in August, the Food and Drug Administration published a memorandum yesterday that indicated Merck's Vioxx painkiller might have contributed to 27,785 heart attacks and deaths from 1999 through 2003.

The memo, based on a sample of patient records, 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 from Pfizer.

The report was part of a study that an F.D.A. researcher, Dr. David J. Graham, conducted with Kaiser Permanente. The general results of the study were reported in August.

The memo by Dr. Graham, an associate director in the F.D.A.'s office of drug safety, was dated Sept. 30, the same day that Merck announced it was pulling Vioxx from the market. Merck attributed the move to its own study indicating that patients who took Vioxx for 18 months or longer were more likely to have a stroke or heart attack than patients taking a placebo.

A Merck spokeswoman, Janet Skidmore, said yesterday that the company had not yet seen the F.D.A. study and had no immediate comment.