NEW YORK (Reuters Health) - MiraLax, which is currently available over-the-counter in the U.S, appears to remain safe and effective when use is extended for up to 6 months in patients with chronic constipation, researchers report in the American Journal of Gastroenterology.
This study extends the formal clinical investigation on the safety of the drug, also known as polyethylene glycol (PEG) 3350, and establishes that it is safe for long-term use, lead investigator Dr. Jack A. DiPalma told Reuters Health.
“Compared with a placebo, MiraLax was effective and had an excellent safety profile,” he said.
DiPalma of the University of South Alabama College of Medicine in Mobile and colleagues note that MiraLax is currently approved for the short-term treatment of occasional constipation.
To examine the effects of long-term use, the researchers studied 304 patients with chronic constipation. At the beginning of the study, constipation was confirmed over a period of 14 days. The patients were then randomly assigned to a single daily dose of MiraLax or placebo for 6 months.
Using relief of constipation of 50 percent or more of the time as a measure of effectiveness, the team established that at 6 months, 52 percent of PEG patients and 11 percent of placebo patients had successful responses. The results were similar in a subgroup of 75 elderly subjects.
Diarrhea, flatulence and nausea were more common in the MiraLax patients, but individually these conditions were not significantly worse than with placebo.
This study provides evidence that MiraLax is safe and effective for treating constipation in adult and elderly patients for up to 6 months, the investigators conclude.
SOURCE: American Journal of Gastroenterology, July 2007.