Most common adverse reactions for split dosing (incidence ³ 5%) are malaise, nausea, abdominal pain, vomiting, and upper abdominal pain (6). The most common adverse reactions for evening only dosing (incidence ³ 5%) are abdominal distension, anal discomfort, thirst, nausea, abdominal pain, sleep disorder, rigors, hunger, malaise, vomiting, and dizziness (6). To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals, Inc. at 1-800-508-0024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies 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 clinical practice. In the MoviPrep trials, abdominal distension, anal discomfort, thirst, nausea, and abdominal pain were some of the most common adverse reactions to MoviPrep administration. Since diarrhea was considered as a part of the efficacy of MoviPrep, diarrhea was not defined as an adverse reaction in the clinical studies. Tables 1 and 2 display the most common drug-related adverse reactions of MoviPrep and its comparator in the controlled MoviPrep trials. Table 1: The Most Common Drug-Related Adverse Reactions1 (≥ 2%) in the Study of MoviPrep vs. 4 Liter Polyethylene Glycol plus Electrolytes Solution MoviPrep® (split dose) N=180 4L PEG + E2 N=179 n (% = n/N) n (% = n/N) Malaise 35 (19.4) 32 (17.9) Nausea 26 (14.4) 36 (20.1) Abdominal pain 24 (13.3) 27 (15.1) Vomiting 14 (7.8) 23 (12.8) Upper abdominal pain 10 (5.6) 11 (6.1) Dyspepsia 5 (2.8) 2 (1.1) 1 Drug-related adverse reactions were adverse events that were possibly, probably, or definitely related to the study drug. 2 4L PEG + E is 4 liter Polyethylene Glycol plus Electrolytes Solution Table 2: The Most Common Drug-Related Adverse Reactions1 (≥ 5%) in the Study of MoviPrep vs. 90 mL Oral Sodium Phosphate Solution MoviPrep® (evening-only) (full dose) N=169 90 mL OSPS2 N=171 n (% = n/N) n (% = n/N) Abdominal distension 101 (59.8) 70 (40.9) Anal discomfort 87 (51.5) 89 (52.0) Thirst 80 (47.3) 112 (65.5) Nausea 80 (47.3) 80 (46.8) Abdominal pain 66 (39.1) 55 (32.2) Sleep disorder 59 (34.9) 49 (28.7) Rigors 57 (33.7) 51 (29.8) Hunger 51 (30.2) 121 (70.8) Malaise 45 (26.6) 90 (52.6) Vomiting 12 (7.1) 14 (8.2) Dizziness 11 (6.5) 31 (18.1) Headache 3 (1.8) 9 (5.3) Hypokalemia 0 (0) 10 (5.8) Hyperphosphatemia 0 (0) 10 (5.8) 1 Drug-related adverse reactions were adverse events that were possibly, probably, or definitely related to the study drug. In addition to the recording of spontaneous adverse events, patients were also specifically asked about the occurrence of the following symptoms: shivering, anal irritations, abdominal bloating or fullness, sleep loss, nausea, vomiting, weakness, hunger sensation, abdominal cramps or pain, thirst sensation, and dizziness. 2 OSPS is Oral Sodium Phosphate Solution Isolated cases of urticaria, rhinorrhea, dermatitis, and anaphylactic reaction have been reported with PEG-based products and may represent allergic reactions. Published literature contains isolated reports of serious adverse events following the administration of PEG-based products in patients over 60 years of age. These adverse events included upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after aspirating PEG-based preparation. 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following adverse events have been identified during post-approval use of MoviPrep. Because they 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. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to MoviPrep, or a combination of these factors. Cardiovascular: Tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema. General: Hypersensitivity reactions including anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness. Fever, chills and dehydration. Nervous system: Syncope, tremor, seizure. Renal: Renal impairment and/or failure.