Ulcertative Colitis (UC) is conventionally managed with corticosteroids (ex. Prednisone), biologics (ex. Humira, Remicade), and aminosalicylates (ex. Lialda, Asacol, Pentasa). We both love and believe in science, and trust the results of multiple clinical trials that have proved the clinical effectiveness of the medications currently used for symptoms management of UC to many patients.
We also discovered during our research the concerning side effects and risks of these medications, as reported by the U.S. Food and Drug Administration (FDA). We believe it is important to be informed about all the benefits as well as the risks of commonly prescribed UC medication. This page aims to introduce you to some of the characteristics of commonly prescribed UC medications as stated on their FDA profiles.
Please consult the Full FDA Profiles for each medication.
Consult your doctor for your personal treatment plan.
- Note: This is not an exhaustive list of UC medications. Please see a comprehensive list of UC medications on this page of the Crohn’s and Colitis Foundation (see Factsheet link under every group). We encourage you to look up the FDA profiles for more information.
1. IMURAN (Azathioprine) (Full FDA Profile)
Page 3: ” Azathioprine suppresses disease manifestations as well as underlying pathology in animal models of autoimmune disease. For example, the severity of adjuvant arthritis is reduced by azathioprine. ”
Page 3: “The mechanisms whereby azathioprine affects autoimmune diseases are not known. Azathioprine is immunosuppressive, delayed hypersensitivity and cellular cytotoxicity tests being suppressed to a greater degree than are antibody responses. In the rat model of adjuvant arthritis, azathioprine has been shown to inhibit the lymph node hyperplasia, which precedes the onset of the signs of the disease. Both the immunosuppressive and therapeutic effects in animal models are dose-related. Azathioprine is considered a slow-acting drug and effects may persist after the drug has been discontinued.”
Page 3: “Patients receiving immunosuppressants, including IMURAN, are at increased risk of developing lymphoma and other malignancies, particularly of the skin. Physicians should inform patients of the risk of malignancy with IMURAN. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor. “
Page 4: “Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with IMURAN. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males.”
Page 4: “The safety and efficacy of IMURAN for the treatment of Crohn’s disease and ulcerative colitis have not been established.”
2. LIALDA (Mesalamine) (Full FDA Profile)
Page 5: “LIALDA tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of LIALDA beyond 8 weeks has not been established.”
Page 3: ” Two similarly designed, randomized, double blind, placebo-controlled trials were conducted in 517 adult patients with active, mild to moderate ulcerative colitis. In both studies, the LIALDA doses of 2.4g/day and 4.8g/day demonstrated superiority over placebo in the primary efficacy endpoint (Table 2). Both LIALDA doses also provided consistent benefit in secondary efficacy parameters, including clinical improvement, treatment failure, clinical remission, and sigmoidoscopic improvement.”
Page 5: “Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache
3. RAYOS (Prednisone) (Full FDA Profile)
Page 1: “RAYOS is a corticosteroid indicated
• as an anti-inflammatory or immunosuppressive agent for certain
allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic,
nervous system, renal, respiratory, rheumatologic, specific infectious
diseases or conditions and organ transplantation”
Page 5: ” Corticosteroids may increase the risks related to infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections.”
Page 7: “Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions..”
Page 6: ” Corticosteroids use may be associated with central nervous system effects ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.”
Page 10: ” Children who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. “
4. Remicade (infliximab) (Full FDA Profile)
Page 4: ” REMICADE is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
Page 4: ” 1.4 Pediatric Ulcerative Colitis. REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. “
Page 26: ” Infliximab neutralizes the biological activity of TNF[alpha] by binding with high affinity to the soluble and transmembrane forms of TNF [alpha] and inhibits binding of TNF [alpha] with its receptors. “
Page 1: ” WARNING: SERIOUS INFECTIONS and MALIGNANCY : Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.”
Page 1: “Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including REMICADE. “
Page 1: “Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including REMICADE. All REMICADE cases were reported in patients with Crohn’s disease or ulcerative colitis, the majority of whom were adolescent or young adult males. ”
5. Humira (adalimumab) (Full FDA Profile)
Page 3: “HUMIRA is a medicine called a Tumor Necrosis Factor (TNF) blocker. HUMIRA is used: […]
- moderate to severe Crohn’s disease (CD) in adults when other treatments have not worked well enough.
- In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
Pages 2: “For children and adults taking TNF-blockers, including HUMIRA, the chances of getting cancer may increase.”
Page 3: “People with RA, especially more serious RA, may have a higher chance
Page 3: “If you use TNF blockers including HUMIRA your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. “
Page 3: “Some people receiving TNF blockers including HUMIRA developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called IMURAN® (azathioprine) or PURINETHOL® (6-mercaptopurine, 6–MP).”
6. Entyvio (Full FDA Profile)
Page 1: ” ENTYVIO is an integrin receptor antagonist indicated for: Adult Ulcerative Colitis (UC) (1.1)
- Adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids:
- inducing and maintaining clinical response
- inducing and maintaining clinical remission
- improving endoscopic appearance of the mucosa
- achieving corticosteroid-free remission.”
Page 1: ” ———————–WARNINGS AND PRECAUTIONS———————– Progressive Multifocal Leukoencephalopathy: Although no cases have been observed in ENTYVIO clinical trials, JCV infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist.”
Note: ” Although not reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus); PML can result in death or severe disability, and there is no known treatment, prevention, or cure for PML.” “Drug Trials Snapshot: Entyvio (vedolizumab) to Treat Ulcerative Colitis,” FDA Website, 05/09/2017.
7. Canassa (Full FDA Profile)
Page 1: ” CANASA is an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.”
Page 5: ” The mechanism of action of mesalamine is not fully understood, but appears to be topical rather than systemic. Although the pathology of inflammatory bowel disease is uncertain, both prostaglandins and leukotrienes have been implicated as mediators of mucosal injury and inflammation. “
Page 7: ” Compared to placebo, mesalamine suppositories were statistically (p<0.01) superior to placebo in both trials with respect to improvement in stool frequency, rectal bleeding, mucosal appearance, disease severity, and overall disease activity after 3 and 6 weeks of treatment. The effectiveness of mesalamine suppositories was statistically significant irrespective of sex, extent of proctitis, duration of current episode, or duration of disease. “
Page 1: “———————–WARNINGS AND PRECAUTIONS——————— Renal Impairment: Evaluate the risks and benefits in patients with These highlights do not include all the information needed to use known renal impairment or taking nephrotoxic drugs; monitor renal CANASA safely and effectively.”
Page 1: “Mesalamine-Induced Acute Intolerance Syndrome: Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute Initial U.S. Approval: 1987 intolerance syndrome is suspected.”