15th July 03:25
F.D.A. Releases Memo on Vioxx (stroke cardiac heart)
Thanks to one of our readers for sending the following. . .Myrl
F.D.A. Releases Memo on Vioxx
By BLOOMBERG NEWS
Published: November 3, 2004
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
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.