Halflytely (Polyethylene Glycol 3350) - Side Effects and Adverse Reactions

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

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.

REPORTS OF SUSPECTED HALFLYTELY SIDE EFFECTS / ADVERSE REACTIONS

Possible Halflytely side effects / adverse reactions in 66 year old male

Reported by a consumer/non-health professional from United States on 2012-03-01

Patient: 66 year old male weighing 61.2 kg (134.7 pounds)

Reactions: Vomiting, Dysstasia, Dizziness, Asthenia, Feeling Cold

Suspect drug(s):
Halflytely
    Indication: Colonoscopy
    Start date: 2012-02-15

Halflytely
    Indication: Bowel Preparation
    Start date: 2012-02-15

Possible Halflytely side effects / adverse reactions in 55 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 55 year old male weighing 98.0 kg (215.5 pounds)

Reactions: Abdominal Pain, Atelectasis, Muscle Disorder, Diverticulum Intestinal, Umbilical Hernia, Pulmonary Fibrosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Halflytely

Other drugs received by patient: Omeprazole; Lisinopril

Possible Halflytely side effects / adverse reactions in 60 year old male

Reported by a physician from United States on 2012-08-01

Patient: 60 year old male weighing 112.0 kg (246.5 pounds)

Reactions: Pulmonary Embolism, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Halflytely