A research trial on a drug which was supposed to treat patients with advanced congestive heart failure (CHF) has been halted after the drug was found to be worsening their condition, even increasing their mortality rate.

The drug, "Remicade" (infliximab) was originally approved by the FDA for short-term use in patients with Crohn's disease. It was later marketed as a treatment for rheumatoid arthritis, before being tested on CHF patients.

Drug companies often try to find new uses for existing drugs since it is thought to be a relatively inexpensive way to increase revenue.

In the six-week aborted Remicade trial, conducted by Remicade manufacturer Centocor, heart patients taking the drugs worsened as compared to those who were not on the medication. Seven of 101 heart patients treated with Remicade died. None of the 49 patients taking a placebo died during the trial.

The failed experiment pointed up a potentially deadly situation involving patients with CHF who are taking the drug for their arthritis. Because of this risk, the FDA issued a warning about the drug and the drug maker sent letters to thousands of doctors alerting them to the risk. Almost five million Americans have congestive heart failure but it is not know how many may also have rheumatoid arthritis or are taking Remicade for it.

SOURCES: FDA MedWatch, Remicade (infliximab) -- Black Box Warning, Oct.23, 2001

"Centocor Places Congestive Heart Failure Clinical Program On Hold," Media Advisory, Centocor, October 22, 2001.