FDA Approves Remicade for Ulcerative Colitis
Drug Also Used to Treat Rheumatoid Arthritis and Crohn's Disease
Sept. 19, 2005 -- The FDA has approved using Remicade to treat patients with moderate to severe ulcerative colitis who haven't completely responded to other treatments. Remicade's maker, Centocor, announced the approval in a news release.
Remicade is also used to treat rheumatoid arthritis and Crohn's disease. It is now the first and only biologic for ulcerative colitis, says Centocor.
Biologics are drugs that target the immune system; they block inflammation and control symptoms. Remicade focuses on a protein called tumor necrosis factor (TNF), which is believed to cause inflammation.
Ulcerative Colitis Trials
Remicade's approval was based on two clinical trials.
Both trials included 364 patients with moderate or severe ulcerative colitis. The patients hadn't responded to at least one standard therapy for ulcerative colitis.
Patients took either Remicade or a fake drug (placebo). Two different doses of Remicade were tested. No one knew which drug or dose the patients got.
More patients taking Remicade had a drop in ulcerative colitis symptoms, got their disease under control (went into remission), and had healing of the intestinal lining, according to Centocor. Centocor is a WebMD sponsor.
Serious side effects were similar to those seen in other clinical trials of Remicade, says Centocor.
Centocor warns that many people with heart failure shouldn't take Remicade and that patients should talk to their doctors about heart health before taking Remicade.
There have been reports of serious infections (including tuberculosis, sepsis, and pneumonia) and rare reports of serious liver problems, blood disorders, and nervous problems in patients taking Remicade, according to the drug's web site.
In December 2004, Centocor and the FDA warned doctors of some
Those problems included acute liver failure and jaundice. Some patients died or required liver transplants. However, there were fewer than 50 reports out of more than half a million patients who have used Remicade.
Patients taking Remicade should consult doctors about issues including:
- New or worsening heart failure symptoms (including shortness of breath and swollen feet or ankles)
- Tendency to develop infections
- History of infections
- Infection symptoms
- Jaundice (yellow skin and eyes)
- Dark brown urine
- Pain on the right side of the abdomen
- Severe fatigue
- Persistent fever, bruising, bleeding, or paleness
- Numbness, weakness, tingling, or visual disturbances
- Current or past cancer
The list comes from Remicade's web site.
Some patients have also had serious reactions while taking Remicade, which is given intravenously. Those reactions include hives, difficulty breathing, and low blood pressure.
Some patients taking Remicade in clinical trials have had respiratory infections, stomach pain, and mild rashes or itchy skin from the infusion, notes Remicade's web site.