(CNN)
-- Johnson & Johnson says its rheumatoid arthritis drug Remicade
may put patients at higher risk for lymphoma, and the company
is sending out warning letters to physicians.
Manufactured by Centocor Inc., a division of Johnson & Johnson,
Remicade is in a class of drugs with Amgen's Enbrel and Abbott
Laboratories' Humira.
Following a Food and Drug Administration advisory meeting
last year, all three drug manufacturers were asked to add
the precautionary label, said a spokesman for Centocor. Centocor
said the label change is in line with warnings recently added
to Enbrel and Humira, according to The Associated Press.
Centocor's Michael Parks said the timing is unrelated to Merck
& Co.'s recent withdrawal of Vioxx, another drug used to treat
arthritis.
"There is not a direct link between an increase in lymphoma
itself, but we did have cases of lymphoma occur in our clinical
trials, and we've been working with the FDA," Parks said.
He said it's not possible to determine if the drug causes
lymphoma or if the underlying conditions of the patients play
a role. Lymphoma is a cancer of the lymphatic system, a network
of small vessels and nodes throughout the body.
Remicade is given to rheumatoid arthritis patients or patients
with a gastrointestinal disorder called Crohn's disease.
"This is not a prescription you pick up in a pharmacy, but
something your doc gives you -- it's an infusion," the Centocor
spokesman said.
As a result, Parks said, the letter explaining the label change
is being sent to physicians, who will be encouraged to share
the information with their patients.
