MOVIPREP SIDE EFFECTS
- Generic Name: peg-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid
- Brand Name: MoviPrep
SIDE EFFECTS
The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:
- Serious Fluid and Electrolyte Abnormalities
- Cardiac Arrhythmias
- Seizures
- Patients with Renal Impairment
- Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis
- Patients with Significant Gastrointestinal Disease
- Aspiration
- Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency
- Risks in Patients with Phenylketonuria
- Hypersensitivity Reactions
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.
The safety of MoviPrep as a Two-Day Split-Dosing and One-Day Evening Only Dosing Regimen was evaluated in two randomized, active-controlled, multicenter, investigator-blinded clinical trials in adult patients scheduled to have an elective colonoscopy. The safety analysis for Study 1 included 359 adult patients ranging in age from 18 to 88 years (mean age 59), with 52% female and 48% male patients. The safety analysis for Study 2 included 340 adult patients ranging in age from 21 to 76 years (mean age 53), with 53% male and 47% female patients.
Tables 1 and 2 display adverse reactions reported in at least 2% and 5% of patients in either treatment group in Study 1 and Study 2, respectively. Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials.
Table 1: Common Adverse Reactions* in Patients Undergoing Colonoscopy in Study 1
| MoviPrep Two-Day Split Dosing Regimen (N=180) |
4 Liter PEG + Electrolytes Solution (N=179) |
|
| Malaise | 19% | 18% |
| Nausea | 14% | 20% |
| Abdominal pain | 13% | 15% |
| Vomiting | 8% | 13% |
| Upper abdominal pain | 6% | 6% |
| Dyspepsia | 3% | 1% |
| * Reported in at least 2% of patients in either treatment group | ||
Table 2: Common Adverse Reactions* † in Patients Undergoing Colonoscopy in Study 2
| MoviPrep One-Day Evening Only Dosing Regimen (N=169) |
90 mL Oral Sodium Phosphate Solution (N=171) |
|
| Abdominal distension | 60% | 41% |
| Anal discomfort | 51% | 52% |
| Thirst | 47% | 65% |
| Nausea | 47% | 47% |
| Abdominal pain | 39% | 32% |
| Sleep disorder | 35% | 29% |
| Rigors | 34% | 30% |
| Hunger | 30% | 71% |
| Malaise | 27% | 53% |
| Vomiting | 7% | 8% |
| Dizziness | 7% | 18% |
| Headache | 2% | 5% |
| Hypokalemia | 0% | 6% |
| Hyperphosphatemia | 0% | 6% |
| *Reported in at least 5% of patients in either treatment group † Patients were 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. |
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Postmarketing Experience
The following adverse reactions have been identified during post-approval use of MoviPrep or other PEG-based 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.
Cardiovascular: Tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema, asystole, acute pulmonary edema and syncope, and dehydration.
Gastrointestinal: upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]
Hypersensitivity reactions: anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness, rhinorrhea, dermatitis, fever, and chills.
Nervous system: tremor, seizure.
Renal: renal impairment and/or failure.
SRC: NLM .