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
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