[TRNSPLNT] Transplant Drug Associated with Deaths
Debi Surlas
Friday, April 26, 2002
WASHINGTON, Apr 26, 2002 (United Press International via COMTEX) -- A drug
that was being studied for use in liver transplant patients should no longer
be used for that purpose because it appears to increase the risk for blood
clots and death, the Food and Drug Administration announced Friday.
Wyeth Pharmaceuticals was conducting studies to see if the drug Rapamune
which is used in kidney transplants, could also be used in liver transplants
when the company determined that patients receiving the drug died at a
higher rate than patients who did not receive it.
Rapamune is an immunosuppressive drug that is used to curb the body's immune
response during transplant operations to prevent rejection of the new organ.
Wyeth issued a letter to transplant surgeons this week informing them that
Rapamune should no longer be used in liver transplant patients. The timing
of the letter coincided with the American Transplant Congress meeting on
Friday in Washington, attended by many transplant surgeons.
The company maintains that the complications are not solely due to Rapamune.
"We can't say that it was specific to Rapamune," Brenda Cooperstone, Wyeth's
senior director of medical affairs, told United Press International.
"These patients were quite ill so there's no way to determine what was the
exact cause of death," she added.
FDA's Marc Cavaille-coll concurred. It is "extremely complicated to
determine the cause death in a transplantation case," Cavaille-coll, who is
a medical officer and team leader in FDA's division special pathogen and
immunologic drug products, told UPI.
He said transplant patients are often on "20 or 30 different medications and
have more than a dozen different diseases," including diabetes,
hypertension, and infections.
In addition, Cavaille-coll added, "Infection is one of the leading causes of
death in transplantation," so it would be difficult to pin the entire cause
of the deaths on Rapamune.
The company notes in the letter it recently determined that Rapamune, when
given to liver transplant patients along with another immunosuppressive
drug, was associated with an "excess rate of death" or rejection of the new
liver.
In two previous studies, Rapamune when used in combination with two other
immunosuppressive drugs was also associated with an increase in blood clots
in the liver. In most cases, this led to the new liver being rejected or
death of the patient.
The company issued a letter last year informing transplant surgeons of the
blood clot risk, Cooperstone said.
Rapamune will continue to be used for kidney transplant operations because
it does not appear to increase the risk of blood clots or death when used
for that purpose, Cavaille-coll said.
Despite the setback, Wyeth remains steadfast that Rapamune can be used in
liver transplants. The company plans to work with transplant experts "to
find ways Rapamune could be used to benefit liver transplant patients,"
Cooperstone said.
This may involve only using the drug in certain patients or giving it much
later after the transplantation procedure has been performed, she said.
Make certain you're sending to trns...@wuvmd.wustl.edu if you're
replying to the entire list.
For signing off, and other commands for TRNSPLNT, use the form at
http://trnsplnt.org