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In the phase 3 Visicol trials, bloating, nausea, abdominal pain, and vomiting were the most common drug-related adverse events reported with the use of Visicol (see Table 2). Since diarrhea was considered as a part of the efficacy of Visicol diarrhea was not defined as an adverse event in the clinical trials. Small superficial mucosal ulcerations, typical of those previously reported from the use of liquid preparations of sodium phosphate, and instances of mucosal bleeding have been observed on colonoscopy.
No patient in the clinical studies developed predefined postural changes in vital signs with concomitant symptoms of lightheadedness or syncope.
Table 2: Frequency of Drug-related* Adverse Events
( ≥ 2%) of Patients in the Phase 3 Visicol Trials (Studies A and B)
|* Drug-related were adverse events possibly or probably drug-related|
In Visicol trials, changes in serum electrolytes (including phosphate, calcium, potassium, and sodium) have been observed in patients taking Visicol Tablets.
In the Visicol phase 3 trials, 96% and < 1% of patients who took Visicol (60 grams) and NuLYTELY (up to 4 liters), respectively, developed hyperphosphatemia (defined as phosphate level > 4.7 mg/dL) on the day of the colonoscopy. In these trials, patients who took Visicol and NuLYTELY had baseline mean phosphate levels of 3.3 and 3.4 mg/dL and subsequently developed on the day of the colonoscopy mean phosphate levels of 7.1, and 3.3 mg/dL, respectively.
Two to three days after colonoscopy, 34%, 66%, and 0% of patients who received Visicol had (reactive) hypophosphatemia (defined as phosphate level < 2.4 mg/dL), normal phosphate levels, and hyperphosphatemia, respectively. Two to three days after colonoscopy, 3%, 96%, and 1% of patients who received NuLYTELY had (reactive) hypophosphatemia normal phosphate levels, and hyperphosphatemia, respectively. Two to three days after colonoscopy, patients who took Visicol and NuLYTELY had mean phosphate levels of 2.6 and 3.3 mg/dL, respectively.
In the Visicol phase 3 trials, 47% and 9% of patients who took Visicol and NuLYTELY, respectively, developed hypocalcemia (defined as calcium level < 8.6 mg/dL) on the day of the colonoscopy. The mean changes in calcium levels (from baseline) for the Visicol and NuLYTELY patients were -0.6 and -0.1 mg/dL, respectively. Furthermore, in these trials, 28% and 3% of patients who took Visicol and NuLYTELY, respectively, developed hypokalemia (defined as potassium level < 3.5 mEq/L) on the day of the colonoscopy. The mean changes in potassium levels (from baseline) for the Visicol and NuLYTELY patients were -0.5 and -0.1 mEq/L, respectively. None of the patients who developed hypocalcemia or hypokalemia in the trials required treatment.
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 following adverse events have been identified during post-approval use of Visicol. 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 either their seriousness, frequency of reporting or causal connection to Visicol, or a combination of these factors.
General: Hypersensitivity reactions including anaphylaxis, rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, paresthesia and swelling of the lips and tongue, and facial swelling.
Nervous system: Seizures
Read the Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) Side Effects Center for a complete guide to possible side effects
Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities
Use caution when prescribing Visicol for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate (see WARNINGS) in patients taking these concomitant medications.
Potential for Altered Drug Absorption
Oral medication administered within one hour of the start of each Visicol dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.
Read the Visicol Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/20/2013
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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