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adverse reactions
6 ADVERSE REACTIONS The most serious adverse reactions seen in DELZICOL clinical trials or with other products that contain or are metabolized to mesalamine are: Renal impairment, including renal failure [see Warnings and Precautions ( 5.1 )] Acute intolerance syndrome [see Warnings and Precautions ( 5.2 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.3 )] Hepatic failure [see Warnings and Precautions ( 5.4 )] The data presented in Section 6.1 are from clinical trials conducted with mesalamine delayed-release tablets. DELZICOL is bioequivalent to these mesalamine delayed-release tablets. The most common adverse reactions (observed in greater than or equal to 5% of adults in clinical trials) were abdominal pain, eructation, pain, back pain, rash, dyspepsia, rhinitis, flu syndrome, asthenia, flatulence, vomiting, fever, arthralgia, constipation, and gastrointestinal bleeding ( 6.1 ) Adverse reactions in children were similar ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-521-8813 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In total, mesalamine delayed-release 400 mg tablets have been evaluated in 2690 patients with ulcerative colitis in controlled and open-label trials. Adverse events presented in the following sections may occur regardless of length of therapy and similar events have been reported in short- and long-term studies and in the postmarketing setting. Clinical studies supporting mesalamine delayed-release tablets use for the treatment of mildly to moderately active ulcerative colitis included two 6-week, placebo-controlled, randomized, double-blind studies in adults with mildly to moderately active ulcerative colitis (Studies 1 and 2), and one 6-week, randomized, double-blind, study of 2 dose levels in children with mildly to moderately active ulcerative colitis. Clinical studies supporting the use of mesalamine delayed-release tablets in the maintenance of remission of ulcerative colitis included a 6-month, randomized, double-blind, placebo-controlled, multi-center study and four active-controlled maintenance trials comparing mesalamine delayed-release with sulfasalazine. Mesalamine delayed-release tablets have been evaluated in 427 adults and 82 children with ulcerative colitis in these controlled studies. Treatment of Mildly to Moderately Active Ulcerative Colitis in Adults In two 6-week placebo-controlled clinical studies (Studies 1 and 2) involving 245 patients, 155 of whom were randomized to mesalamine delayed-release tablets [see Clinical Studies ( 14.1 )] , 3.2% of the mesalamine delayed-release tablets-treated patients discontinued therapy because of adverse reactions as compared to 2.2% of the placebo-treated patients. The average age of patients in Study 1 was 42 years and 48% of patients were male. The average age of patients in Study 2 was 42 years and 59% of patients were male. Adverse reactions leading to withdrawal from mesalamine delayed-release tablets included (each in one patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache; rash, lethargy and constipation; dry mouth, malaise, lower back discomfort, mild disorientation, mild indigestion and cramping; headache, nausea, aching, vomiting, muscle cramps, a stuffy head, plugged ears, and fever. Adverse reactions in patients treated with mesalamine delayed-release tablets occurring at a frequency of at least 2% and at a rate greater than placebo in 6-week, double-blind, placebo-controlled trials (Studies 1 and 2) are listed in Table 1 below. Table 1: Adverse Reactions Reported in Two Six-Week Placebo-Controlled Trials (Studies 1 and 2) Experienced by at Least 2% of patients in the mesalamine delayed-release tablets Group and at a Rate Greater than Placebo % of Patients with Adverse Reactions Adverse Reaction mesalamine delayed-release tablets Placebo (n = 152) (n = 87) Abdominal pain 18 14 Eructation 16 15 Pain 14 8 Back pain 7 5 Rash 6 3 Dyspepsia 6 1 Arthralgia 5 3 Vomiting 5 2 Constipation 5 1 Chest pain 3 2 Chills 3 2 Peripheral edema 3 2 Myalgia 3 1 Sweating 3 1 Pruritus 3 0 Acne 2 1 Malaise 2 1 Arthritis 2 0 Treatment of Mildly to Moderately Active Ulcerative Colitis in Pediatric Patients 5 to 17 Years Old A randomized, double-blind, 6-week study of 2 dose levels of mesalamine delayed-release 400 mg tablets (Study 3) was conducted in 82 pediatric patients 5 to 17 years of age with mildly to moderately active ulcerative colitis. All patients were divided by body weight category (17 to less than 33 kg, 33 to less than 54 kg, and 54 to 90 kg) and randomly assigned to receive a low dose (1.2, 2.0, and 2.4 g/day for the respective body weight category) or a high dose (2.0, 3.6, and 4.8 g/day). The high dose is not an approved dosage because it was not found to be more effective than the approved dose [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14.1 )]. Duration of exposure to mesalamine among the 82 patients in the study ranged from 12 to 50 days (mean of 40 days in each dose group). The majority (88%) of patients in each group were treated for more than 5 weeks. Table 2 provides a summary of the specific reported adverse reactions (ARs). Table 2: Adverse Reactions Reported in One Six-Week Trial (Study 3) Experienced by at Least 5% of Patients in the Low Dose Group or High Dose Group % of Patients with Adverse Reactions Low Dose High Dose Adverse Reaction (n=41) (n=41) Nasopharyngitis 15 12 Ulcerative Colitis 12 5 Headache 10 5 Abdominal pain 10 2 Dizziness 7 2 Sinusitis 7 0 Rash 5 5 Cough 5 0 Diarrhea 5 0 Fatigue 2 10 Pyrexia 0 7 Increased Lipase 0 5 Low Dose = mesalamine 400 mg delayed-release tablet 1.2 - 2.4 g/day; High Dose = mesalamine 400 mg delayed-release tablet 2.0 - 4.8 g/day. Dosage was dependent on body weight. Adverse Reactions reported at the 1-week telephone follow-up visit are included. Twelve percent of the patients in the low dose group and 5% of the patients in the high dose group had serious adverse reactions (ARs). Ulcerative colitis was reported as a serious AR in one subject in each group. Other serious ARs consisted of sinusitis, abdominal pain, decreased body mass index, adenovirus infection, bloody diarrhea, sclerosing cholangitis, and pancreatitis in one subject each in the low dose group and anemia and syncope in one subject each in the high dose group. Seven patients were withdrawn from the study because of ARs: 5 (12%) in the low dose group (ulcerative colitis, adenovirus infection, sclerosing cholangitis, pancreatitis) and 2 (5%) in the high dose group (increased amylase and increased lipase, upper abdominal pain). In general, the nature and severity of reactions in the pediatric population was similar to those reported in adult populations of patients with ulcerative colitis. Maintenance of Remission of Ulcerative Colitis in Adults In a 6-month placebo-controlled maintenance trial involving 264 patients (Study 4) 177 of whom were randomized to mesalamine delayed-release tablets, six (3.4%) of the patients using mesalamine delayed-release tablets discontinued therapy because of adverse reactions, as compared to four (4.6%) of patients using placebo [see Clinical Studies ( 14.2 )] . The average age of patients in Study 4 was 42 years and 55% of patients were male. Adverse reactions leading to study withdrawal in patients using mesalamine delayed-release tablets included (each in one patient): anxiety; headache; pruritus; decreased libido; rheumatoid arthritis; and stomatitis and asthenia. In addition to reactions listed in Table 1 , the following adverse reactions occurred in patients using mesalamine delayed-release tablets at a frequency of 2% or greater in Study 4: abdominal enlargement, gastroenteritis, gastrointestinal hemorrhage, infection, joint disorder, migraine, nervousness, paresthesia, rectal disorder, rectal hemorrhage, stool abnormalities, tenesmus, urinary frequency, vasodilation, and vision abnormalities. In 3342 patients in uncontrolled clinical studies, the following adverse reactions occurred at a frequency of 5% or greater and appeared to increase in frequency with increasing dose: asthenia, fever, flu syndrome, pain, abdominal pain, back pain, flatulence, gastrointestinal bleeding, arthralgia, and rhinitis. 6.2 Postmarketing Experience In addition to the adverse reactions reported above in clinical trials involving mesalamine delayed-release tablets, the adverse reactions listed below have been identified during post-approval use of mesalamine delayed-release tablets and other mesalamine-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: Neck pain, facial edema, edema, lupus-like syndrome, drug fever. Cardiovascular: Pericarditis, myocarditis [see Warnings and Precautions ( 5.3 )]. Gastrointestinal: Anorexia, pancreatitis, gastritis, increased appetite, cholecystitis, dry mouth, oral ulcers, perforated peptic ulcer bloody diarrhea. Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, eosinophilia, leukopenia, anemia, lymphadenopathy. Musculoskeletal: Gout. Nervous: Depression, somnolence, emotional lability, hyperesthesia, vertigo, confusion, tremor, peripheral neuropathy, transverse myelitis, Guillain-Barré syndrome. Renal: Renal failure, interstitial nephritis, minimal change nephropathy [see Warnings and Precautions ( 5.1 )] . Respiratory/Pulmonary: Eosinophilic pneumonia, interstitial pneumonitis, asthma exacerbation, pleuritis. Skin: Alopecia, psoriasis, pyoderma gangrenosus, dry skin, erythema nodosum, urticaria. Special Senses: Eye pain, taste perversion, blurred vision, tinnitus. Urogenital: Dysuria, urinary urgency, hematuria, epididymitis, menorrhagia, reversible oligospermia. Laboratory Abnormalities: Elevated AST (SGOT) or ALT (SGPT), elevated alkaline phosphatase, elevated GGT, elevated LDH, elevated bilirubin, elevated serum creatinine and BUN.