OSMOPREP SIDE EFFECTS

SIDE EFFECTS

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:

• Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders
• Cardiac Arrhythmias
• Seizures
• Use in Patients with Significant Gastrointestinal Disease
• Colonic Mucosal Ulceration and Inflammatory Bowel Disease
• Aspiration
• Hypersensitivity Reactions

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 OsmoPrep was evaluated in two randomized, investigator-blinded, active controlled trials in 931 adult patients undergoing elective colonoscopy. The mean age of the study population was 60 years (range 20 to 89 years), 88% of patients were Caucasian and 55% were female.

Table 1 shows the most common adverse reactions reported in greater than 3% of patients by treatment group in Study 1.Since diarrhea was considered as a part of the efficacy of OsmoPrep, diarrhea was not defined as an adverse event in this clinical trial.

Table 1: Common Adverse Reactions¹ in Patients Undergoing Colonoscopy in Study 1

Electrolyte Abnormalities In Study 1

Hyperphosphatemia

A total of, 96%, 96%, and 93% of patients who took 60 grams of oral sodium phosphate, 60 grams of OsmoPrep, and 48 grams of OsmoPrep, respectively, developed hyperphosphatemia (defined as phosphate level > 5.1 mg/dL) on the day of the colonoscopy. In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of OsmoPrep, and 48 grams of OsmoPrep had baseline mean phosphate levels of 3.5, 3.5, and 3.6 mg/dL and subsequently developed mean phosphate levels of 7.6, 7.9, and 7.1 mg/dL, respectively, on the day of the colonoscopy.

Hyperkalemia

A total of 20%, 22%, and 18% of patients who took 60 grams of oral sodium phosphate, 60 grams of OsmoPrep, and 48 grams of OsmoPrep, respectively, developed hypokalemia (defined as a potassium level < 3.4 mEq/L) on the day of the colonoscopy. In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of OsmoPrep, and 48 grams of OsmoPrep all had baseline potassium levels of about 4.3 mEq/L and then developed a mean potassium level of 3.7 mEq/L on the day of the colonoscopy.

Several patients on all three sodium phosphate regimens developed hypocalcemia and hypernatremia that did not require treatment.

The OsmoPrep 60-gram dosage regimen was associated with an increased risk of adverse reactions compared to the 48gram dosage regimen and a similar overall response rate. Therefore, the OsmoPrep 60-gram dosage is not a recommended regimen.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of OsmoPrep. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions: anaphylaxis, angioedema (swelling of the lips, tongue and face), rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, and paresthesia.

Cardiovascular: Arrhythmias

Nervous system: Seizures

Renal: Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis.

SRC: NLM .