Colazal Side Effects, and Drug Interactions - Balsalazide

Colazal Side Effects, and Drug Interactions - Balsalazide

SIDE EFFECTS

Over 1000 patients received treatment with COLAZAL ™ in domestic and foreign clinical trials. In four controlled clinical trials patients receiving a COLAZAL ™ dose of 6.75 grams/day most frequently reported the following events (reporting frequency ≥3%), headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable among patients on COLAZAL ™ and placebo.

Adverse events reported by 1% or more of patients who participated in the four well-controlled, Phase 3 trials are presented by treatment group (Table 1).

The number of placebo patients is too small for valid comparisons. Some adverse events, such as abdominal pain, fatigue, and nausea were reported more frequently in women subjects than in men. Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.

The following adverse events, presented by body system, have also been infrequently reported by patients taking COLAZAL ™ during clinical trials (n = 513) for the treatment of active acute ulcerative colitis or from foreign post-marketing reports. In most cases no relationship to COLAZAL ™ has been established.

Body as a Whole: abdomen enlarged, asthenia, chest pain, chills, edema, hot flushes, malaise

Cardiovascular and vascular: bradycardia, deep venous thrombosis, hypertension, leg ulcer, palpitations, pericarditis

Gastrointestinal: amylase increased, bowel irregularity, colitis ulcerative aggravated, diarrhea with blood, diverticulosis, epigastric pain, eructation, fecal incontinence, feces abnormal, gastroenteritis, giardiasis, glossitis, hemorrhoids, melena, neoplasm benign, pancreatitis, ulcerative stomatitis, stools frequent, tenesmus, tongue discoloration

Hematologic: anemia, epistaxis, fibrinogen plasma increase, hemorrhage, prothrombin decrease, prothrombin increase, thrombocythemia

Liver and biliary: bilirubin increase, hepatic function abnormal, SGOT increase, SGPT increase

Lymphatic: eosinophilia, granulocytopenia, leukocytosis, leukopenia, lymphadenopathy, lymphoma-like disorder, lymphopenia

Metabolic and nutritional: creatinine phosphokinase increased, hypocalcemia, hypokalemia, hypoproteinemia, LDH increase, weight decrease, weight increase

Musculoskeletal: arthritis, arthropathy, stiffness in legs

Nervous: aphasia, dysphonia, gait abnormal, hypertonia, hypoesthesia, paresis, spasm generalized, tremor

Psychiatric: anxiety, depression, nervousness, somnolence

Reproductive: menstrual disorder

Resistance Mechanism: abscess, immunoglobulins decrease, infection, moniliasis, viral infection

Respiratory: bronchospasm, dyspnea, hemoptysis

Skin: alopecia, angioedema, dermatitis, dry skin, erythema nodosum, erythematous rash, pruritus, pruritus ani, psoriasis, skin ulceration

Special Senses: conjunctivitis, earache, ear infection, iritis, parosmia, taste perversion, tinnitus, vision abnormal

Urinary: hematuria, interstitial nephritis, micturition frequency, polyuria, pyuria

Post Marketing Reports:

The following events have been identified during post-approval use in clinical practice, of products which contain (or are metabolized to) mesalamine. Because they are reported voluntarily from a population of unknown size estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine.

Gastrointestinal: Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal, however, no fatalities associated with these events were reported in COLAZAL ™ clinical trials. One case of Kawasaki-like syndrome which included hepatic function changes was also reported, however, this event was not reported in COLAZAL ™ clinical trials.

DRUG ABUSE AND DEPENDENCY

Abuse: None reported

Dependency: Drug dependence has not been reported with chronic administration of mesalamine.

No drug interaction studies have been conducted for COLAZAL ™, however the use of orally administered antibiotics could, theoretically, interfere with the release of mesalamine in the colon.