Rheumatoid Arthritis Drug Side Effects: Tuberculosis? Death?

There are new concerns tonight about dangerous side effects associated with some drugs for rheumatoid arthritis. A Food and Drug Administration advisory panel has been considering the problem, and CBS News medical correspondent Elizabeth Kaledin has our report.

Ever since the rheumatoid arthritis drug Remicade hit the market, it came with a powerful warning: "Serious infections requiring hospitalization may occur . . ."

But now an FDA advisory panel is trying to decide if that caveat is strong enough in the wake of a growing list of problems associated with Remicade and its cousin, Enbrel.

Rheumatoid arthritis is an immune system malfunction in which cells that normally fight infection turn on the body--often attacking and destroying joints. Enbrel and Remicade work by protecting the joints from the body's own immune system.

Dr. Steven Abramson is on the FDA panel.

"These are immunosuppressant agents so you can get infections you might not otherwise have," says Abramson, who practices at the New York University Hospital for Joint Diseases.

In fact, reports obtained by CBS News show that dozens of people on these drugs have needed emergency hospital care. And more troubling, there have been 22 reported deaths of people taking Enbrel and 48 deaths of people taking Remicade.

The people who died were all taking other medications and had other illnesses, and the drug company says problems are well within normal range.

Leslie Garrison of Immunex says, "We've been very impressed with rare events happening but always at or below the rate in the general population."

It's a paradox for the FDA, which is also faced with glowing success stories from people like Heidi McIntyre, who says Enbrel has been nothing short of miraculous for her.

"I would say in 25 years there has not been a single drug that has touched my arthritis in a positive way except this one," says McIntyre. "It's given me a big part of my life back."

Warning labels have already been changed five times, so the question of what to do with these drugs that have hurt some and helped many will be a difficult one for the FDA, which ended its meeting today taking no action.
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