What is ulcerative colitis (UC)?
UC is an ongoing disease of the colon, or large intestine. UC is known as an inflammatory bowel disease (IBD)—a term used to describe a number of inflammatory diseases that affect the gastrointestinal (GI) tract. If you have an inflammatory disorder such as UC, your immune system attacks your own GI tissue.
People with UC can experience a number of signs and symptoms, including severe abdominal cramping and pain, fatigue, and the sudden, uncontrollable urge for bowel movements. But with appropriate medical treatment, many people with UC are able to achieve real symptom control.
What causes UC?
While the direct cause of UC is unknown, here's what we do know. First, you may be more likely to experience UC if it's part of your family's medical history. Second, UC symptoms begin when your immune system attacks healthy cells in your body, for reasons we do not yet understand.
Normally, the immune system (the body's natural defense system) protects your body from bacteria, viruses, and other foreign agents. When you have UC, your immune system incorrectly targets your GI tract. This causes inflammation—leading to the symptoms and flares usually experienced with UC.
Who gets UC?
UC typically develops in people between the ages of 15 and 30. However, it is possible for anyone at any age to develop UC
People of Caucasian and Jewish origins have a higher risk of developing IBD compared with other racial and ethnic subgroups
Hear from actual patients with moderately to severely active UC who didn’t respond well to other therapies and were treated with REMICADE®. Individual results may vary.
Symptoms and diagnosis
The most common symptoms of UC include blood in the stool or bloody diarrhea, abdominal pain, cramping, and the sudden urge for bowel movements.
Other symptoms of UC include:
- Severe diarrhea
- Weight loss
- Frequent bowel movements
- Loss of appetite
- Rectal bleeding
Some people with UC may also have tiny open sores (or ulcers) that form on the surface of the lining of the colon. These sores may bleed and produce pus and mucus. Because inflammation makes the colon empty frequently, other complications can arise, such as unwanted weight loss and blood loss.
How is UC diagnosed?
Your doctor will take several steps in order to accurately diagnose UC. These steps will also help rule out other possible causes of your symptoms, such as a bacterial or viral infection, and make sure you don't have another gastrointestinal problem like Crohn's disease. To do this, your doctor will look at your medical history and perform a thorough physical exam as well as several tests.
The tests your doctor will perform may include:
- Stool examination: Analyzing a stool sample can help your gastroenterologist eliminate possible bacterial, viral, or parasitic causes of your diarrhea
- Blood tests: Your gastroenterologist will perform blood tests to look for anemia, white blood cell count, and other markers that could indicate an infection or inflammation
- Colonoscopy or sigmoidoscopy: These tests may be performed to confirm the diagnosis of UC or to determine the extent of inflammation inside the intestine
- Barium enema X-ray: This test gives your doctor a detailed view of the colon, including any ulcers or other abnormalities
UC and Crohn's disease
Sometimes other conditions can cause abdominal symptoms that appear to be similar to those of UC. Crohn's disease, for example, also causes inflammation of the lining of your digestive tract, which can lead to abdominal pain, severe diarrhea, and loss of appetite.
REMICADE® can lower your ability to fight infections. Serious and sometimes fatal events can occur. There have been reports of serious infections including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that have spread throughout the body. Lymphoma, including a fatal kind called hepatosplenic T-cell lymphoma, and other cancers have been reported in children and adults taking REMICADE®. Some people with heart failure should not take REMICADE®. Other serious side effects reported include skin cancer, hepatitis B, liver injury, blood problems, allergic reactions, nervous system problems, or lupus-like syndrome. To learn more about these and other risks, please read the Important Safety Information and the Medication Guide, and talk with your doctor.
Only your doctor can recommend a course of treatment after checking your health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase.
You should discuss any concerns about your health and medical care with your doctor.
What should I tell my doctor before I take REMICADE®?
You should let your doctor know if you have or ever had any of the following:
- Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE®.
- Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
- Infections that keep coming back, have diabetes or an immune system problem.
- Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
- Heart failure or any heart condition. Many people with heart failure should not take REMICADE®.
- Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV.
- Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).
Also tell your doctor if you:
- Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as REMICADE®.
- Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using REMICADE® during your pregnancy. Tell your baby’s doctor about your REMICADE® use before the baby receives any vaccine because of an increased risk of infection for up to 6 months after your last dose of REMICADE® you received during your pregnancy.
- Recently received or are scheduled to receive a vaccine. Adults and children taking REMICADE® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking REMICADE®.
What should I watch for and talk to my doctor about before or while taking REMICADE®?
The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.
You should tell your doctor right away if you have any of the signs listed below:
- Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE® can make you more likely to get an infection or make any infection that you have worse.
- Lymphoma, or any other cancers in adults and children.
- Skin cancer—any changes in or growths on your skin.
- Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
- Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
- Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
- Blood disorders—fever that doesn’t go away, bruising, bleeding or severe paleness.
- Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
- Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
- Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
- Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.
Please read the accompanying Medication Guide for REMICADE® and talk with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.