Firm warns doctors of arthritis drug risk

October 9, 2004
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.