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adverse reactions
6 ADVERSE REACTIONS Systemic glucocorticosteroid use may result in the following: Hypercorticism and Adrenal Suppression [ ] • see Warnings and Precautions (5.1) Symptoms of steroid withdrawal in those patients transferring from Systemic Glucocorticosteroid Therapy [ ] • see Warnings and Precautions (5.2) Immunosuppression [ ] • see Warnings and Precautions (5.3) Increased Systemic Glucocorticosteroid Susceptibilty [ ] • see Warnings and Precautions (5.4) Other Glucocorticosteroid Effects [ ] • see Warnings and Precautions (5.5) Most common adverse reactions (≥ 5%) are headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, pain. ( ) 6.1 To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) 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. The safety of budesonide capsules (enteric coated) was evaluated in 651 patients in five short-term, active disease state studies. They ranged in age from 17 to 74 (mean 35), 40% were male and 97% were white, 2.6% were greater than or equal to 65 years of age. Five hundred and twenty patients were treated with budesonide capsules (enteric coated) 9 mg (total daily dose). The most common adverse reactions reported were headache, respiratory infection, nausea, and symptoms of hypercorticism. Clinical studies have shown that the frequency of glucocorticosteroid-associated adverse reactions was substantially reduced with budesonide capsules (enteric coated) compared with prednisolone at therapeutically equivalent doses. Adverse reactions occurring in greater than or equal to 5% of the patients are listed in Table 1: Table 1. Adverse Reactions Occurring in Greater Than or Equal to 5% of the Patients in Any Treated Group Budesonide Capsules (Enteric Coated) 9 mg n = 520 Placebo n = 107 Prednisolone 40 mg n = 145 Comparator This drug is not approved for the treatment of Crohn’s disease in the United States. n = 88 Adverse Reaction Number (%) Number (%) Number (%) Number (%) Headache 107(21) 19(18) 31(21) 11(13) Respiratory Infection 55(11) 7(7) 20(14) 5(6) Nausea 57(11) 10(9) 18(12) 7(8) Back Pain 36(7) 10(9) 17(12) 5(6) Dyspepsia 31(6) 4(4) 17(12) 3(3) Dizziness 38(7) 5(5) 18(12) 5(6) Abdominal Pain 32(6) 18(17) 6(4) 10(11) Flatulence 30(6) 6(6) 12(8) 5(6) Vomiting 29(6) 6(6) 6(4) 6(7) Fatigue 25(5) 8(7) 11(8) 0(0) Pain 24(5) 8(7) 17(12) 2(2) The safety of budesonide capsules (enteric coated) was evaluated in 233 patients in four long-term clinical trials (52 weeks). A total of 145 patients were treated with budesonide capsules (enteric coated) 6 mg. A total of 8% of budesonide capsule (enteric coated) patients discontinued treatment due to adverse reactions compared with 10% in the placebo group. The adverse reaction profile in long-term treatment of Crohn’s disease was similar to that of short-term treatment with budesonide capsules (enteric coated) 9 mg in active Crohn’s disease. In the long-term clinical trials, the following adverse reactions occurred in greater than or equal to 5% of the 6 mg budesonide capsule (enteric coated) patients and are not listed in (Table 1) or by body system below: diarrhea (10%); sinusitis (8%); infection viral (6%); and arthralgia (5%). Adverse reactions, occurring in patients treated with budesonide capsules (enteric coated) 9 mg (total daily dose) in short-term active disease state studies and/or budesonide capsules (enteric coated) 6 mg (total daily dose) long-term, with an incidence less than 5% and greater than placebo are listed below by system organ class: leukocytosis Blood and lymphatic system disorders: palpitation, tachycardia Cardiac disorders: eye abnormality, vision abnormal Eye disorders: asthenia, chest pain, dependent edema, face edema, flu-like disorder, malaise, fever General disorders and administration site conditions: anus disorder, Crohn’s disease aggravated, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder Gastrointestinal disorders: Ear infection-not otherwise specified, bronchitis, abscess, rhinitis, urinary tract infection, thrush Infections and infestations: c-reactive protein increased, weight increased Investigations: appetite increased, hypokalemia Metabolism and nutrition disorders: arthritis, cramps, myalgia Musculoskeletal and connective tissue disorders: hyperkinesia, parasthesia, tremor, vertigo, dizziness, somnolence, amnesia Nervous system disorders: agitation, confusion, insomnia, nervousness, sleep disorder Psychiatric disorders: dysuria, micturition frequency, nocturia Renal and urinary disorders: intermenstrual bleeding, menstrual disorder Reproductive system and breast disorders: dyspnea, pharynx disorder Respiratory, thoracic and mediastinal disorders: acne, alopecia, dermatitis, eczema, skin disorder, sweating increased, purpura Skin and subcutaneous tissue disorders: flushing, hypertension Vascular disorders: Table 2 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in short-term clinical trials. Table 2. Summary and Incidence of Signs/Symptoms of Hypercorticism in Short-Term Studies Budesonide Capsules (Enteric Coated) 9 mg n = 427 Placebo n = 107 Prednisolone Taper 40 mg n = 145 Signs/Symptom Number (%) Number (%) Number (%) Acne 63(15) 14(13) 33(23) Statistically significantly different from budesonide capsules (enteric coated) 9 mg. Bruising Easily 63(15) 12(11) 13(9) Moon Face 46(11) 4(4) 53(37) Swollen Ankles 32(7) 6(6) 13(9) Hirsutism Adverse reaction dictionary included term hair growth increased, local and hair growth increased, general. 22(5) 2(2) 5(3) Buffalo Hump 6(1) 2(2) 5(3) Skin Striae 4(1) 2(2) 0(0) Table 3 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in long-term clinical trials. Table 3. Summary and Incidence of Symptoms of Hypercorticism in Long-Term Studies Budesonide Capsules (Enteric Coated) 3 mg n = 88 Budesonide Capsules (Enteric Coated) 6 mg n = 145 Placebo n = 143 Signs/Symptom Number (%) Number (%) Number (%) Bruising Easily 4(5) 15(10) 5(4) Acne 4(5) 14(10) 3(2) Moon Face 3 (3) 6(4) 0 Hirsutism 2 (2) 5(3) 1(1) Swollen Ankles 2 (2) 3(2) 3(2) Buffalo Hump 1 (1) 1 (1) 0 Skin Striae 2 (2) 0 0 The incidence of signs/symptoms of hypercorticism as described above in long-term clinical trials was similar to that seen in the short-term clinical trials. A randomized, open, parallel-group multicenter safety study specifically compared the effect of budesonide capsules (enteric coated) (less than 9 mg per day) and prednisolone (less than 40 mg per day) on bone mineral density over 2 years when used at doses adjusted to disease severity. Bone mineral density decreased significantly less with budesonide capsules (enteric coated) than with prednisolone in steroid-naïve patients, whereas no difference could be detected between treatment groups for steroid-dependent patients and previous steroid users. The incidence of symptoms associated with hypercorticism was significantly higher with prednisolone treatment. Clinical Laboratory Test Findings The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to budesonide capsules (enteric coated), were reported in greater than or equal to 1% of patients: hypokalemia, leukocytosis, anemia, hematuria, pyuria, erythrocyte sedimentation rate increased, alkaline phosphatase increased, atypical neutrophils, C-reactive protein increased, and adrenal insufficiency. 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of budesonide capsules (enteric coated). 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. Anaphylactic reactions Immune System Disorders: Benign intracranial hypertension Nervous System Disorders: Mood swings Psychiatric Disorders: