Guest guest Posted October 22, 2001 Report Share 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 Link to comment Share on other sites More sharing options...
Guest guest Posted April 19, 2005 Report Share 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 Link to comment Share on other sites More sharing options...
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