October 23, 2001 WASHINGTON (AP) - Patients with congestive heart failure should not begin using the rheumatoid arthritis drug Remicade, the drug's makers warned physicians.
In clinical trials, the heart patients on Remicade got much sicker than those patients who weren't using the drug, said Centocor. Seven of 101 heart patients treated with Remicade died, compared to zero out of 49 patients taking a placebo in the roughly 6-week trial, the company's statement said.
Doctors are also being told to re-evaluate Remicade therapy for patients with congestive heart failure, a heart weakened by age, damage from a heart attack or some other condition.
Remicade treatment should stop if a patient's heart condition gets worse, said Centocor, which consulted with the Food and Drug Administration.
The Malvern, Pa. -based company conducted the clinical trials because animal testing had shown Remicade might help treat congestive heart failure, said FDA spokeswoman Lenore Gelb.
The warning came in letters mailed last week to 35,000 physicians who are likely to treat such patients, said Bill Heineke, a spokesman for Centocor.
A genetically engineered drug, Remicade treats rheumatoid arthritis. The conditions afflicts more than 2 million Americans and is different from the common form of arthritis that results from the wear-and-tear of aging. Rheumatoid arthritis causes destruction of bone and cartilage in joints.
Remicade also is sold to treat the inflammatory bowel disorder Crohn's disease.
Almost 5 million Americans have congestive heart failure. Centocor urged doctors to report any worsening cases to the company or the FDA.
Copyright 2001 The Associated Press. All rights reserved.
