Since it was first introduced 13 years ago, a drug called Miralax — an odorless, tasteless laxative that can be easily diluted in orange juice or water — has become a staple in many American households.
But the way many families use Miralax and its many generic equivalents has strayed far from its original intent. The Food and Drug Administration approved the drug for use only by adults, and for only seven days at a time.
Instead, Miralax has become a long-term solution for childhood constipation — a problem that can be troubling not just physically, but also emotionally — rather than a short-term fix so that parents can change their children’s diets to include more fruits and vegetables.
“I’ve had kids on it daily for years,” said Dr. Scott W. Cohen, a pediatrician in Beverly Hills, Calif., adding that he will generally refer them to a specialist in prolonged cases. For children with chronic constipation who are not being helped by dietary changes, “We literally give it like water.”
No studies have shown that the drug’s active ingredient — polyethylene glycol 3350, or PEG — has severe side effects. But there is a growing chorus of questions about why it has been used and prescribed for children for so many years.
Last week, for example, the Empire State Consumer Project, a New York consumer group, sent a citizen petition to the F.D.A. on behalf of parents concerned about the increase in so-called adverse events related to PEG that health professionals and consumers have reported to the F.D.A. over the past decade.
The warning label on Miralax does not reflect a known risk to children. It means only that no long-term studies that meet the F.D.A.’s standards have been conducted on children using Miralax and its generic counterparts, which work by drawing water into the colon. However, discussion groups on many Web sites suggest that thousands of parents have questions and concerns about it, including the effects of long-term use.
