Guest guest Posted October 22, 2001 Report Posted October 22, 2001 > Doctors Warned About Arthritis Drug > > > > Updated: Mon, Oct 22 5:32 PM EDT > > > By ANJETTA McQUEEN, Associated Press Writer > > 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 > at 1-800-457-6399 or the FDA by calling > 1-800-FDA-1088. > > -- > > On the Net: > > Centocor: http://www.centocor.com > > FDA MedWatch: http://www.fda.gov/medwatch Quote
Guest guest Posted April 19, 2005 Report Posted April 19, 2005 New warnings of serious adverse events including liver failure requiring transplantation. The short article has a link to the FDA website for the full report. http://www.nursesdrughandbook.com/news/index.cfm?ID=152 Quote
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