ADVERSE REACTIONS
Nausea, cramping and abdominal fullness are the most common adverse reactions (occurring in up to 50% of patients) to administration of HalfLytely and Bisacodyl Tablets Bowel Prep Kit. Vomiting occurs less frequently (approximately 2.7% of patients versus 6.7% of patients taking large volume PEG solutions). In clinical studies, most of these complaints were significantly reduced when compared to the 4 liter preparation. Table 1 shows patient rating of symptoms associated with the preparation from 2 clinical studies (n= 400). These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported with PEG based products which may represent allergic reactions
Table 1: Patient Symptom Rating
Bothersome-Severe Complaints
|
|
HalfLytely
and Bisacodyl
Tablets Bowel
Prep Kit
|
4 liters
of PEG
electrolyte
solution
|
|
Nausea
|
17.1%
|
31.8%
|
|
Cramping
|
9.1%
|
17.4%
|
|
Fullness
|
22.3%
|
44.1%
|
|
Vomiting
|
5.9%
|
13.7%
|
Overall
Discomfort
|
19.1%
|
37.3%
|
|
Published literature contains isolated reports of serious adverse reactions following the administration of (4L) PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss syndrome esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrate on chest X-ray after vomiting and aspirating PEG.
In addition, during administration of 4L PEG-3350 bowel cleansing preparations the following serious adverse events were seen: two deaths in end-stage renal failure patients who developed diarrhea, vomiting, dysnatremia; tonic-clonic seizures in patients with and without prior history of seizures. These adverse events have not been reported in HalfLytely and Bisacodyl Tablets Bowel Prep Kit clinical trials.
|
