MiraLAX® a popular cure but never approved for children

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.

In interviews, more than a dozen doctors nationwide, including pediatricians and gastroenterologists, said that they routinely see young patients who have been on Miralax for months and years. Many doctors acknowledged that they have recommended the use of PEG to treat childhood constipation over long periods.

Dr. Dean Focht, a pediatric gastroenterologist at Geisinger Medical Center in Danville, Pa., has known about Miralax’s popularity for years. He was the lead author of a peer-reviewed study in 2006, the year it became an over-the-counter drug, that found 75 percent of about 350 pediatricians nationwide had suggested parents use Miralax or similar generics to treat childhood constipation.

Dr. Focht said he is seeing more children who having been taking it for long stretches, even though the label warns that it should be used only for seven days and that parents should consult a doctor before treating children younger than 17. “It’s definitely not unheard-of that kids are on it for years,” Dr. Focht said.

Despite the drug’s popularity, it has never been approved by the F.D.A. for pediatric use. In 1999, when the F.D.A. first approved Miralax, the patient materials included the warning: “Miralax should not be used by children.” In 2009, an F.D.A. drug safety oversight board raised a number of concerns about PEG’s use in children, including the uncertainty of the long-term effects of large doses, but concluded that current evidence does not suggest that PEG causes severe side effects.

Even so, some doctors said they are concerned about the lack of information about its long-term effects. “We don’t know 30 years from now what will happen,” said, Dr. Carlo Di Lorenzo, the chief of the gastroenterology department at Nationwide Children’s Hospital in Columbus, Ohio.

Still, Dr. Di Lorenzo, who once did a study financed by a company that produced Miralax before Merck, is not alarmed. “As far as we know, polyethylene glycol is safe,” he said.

In a statement, Merck said it recommends the use of Miralax only for patients 17 and older and only for a week, and added that it “regularly analyzes and reports all adverse event information as part of our ongoing post-marketing surveillance.” Asked whether it plans to conduct studies to get F.D.A. approval for pediatric use, the company declined to say.

After its 2009 drug oversight meeting, the F.D.A. decided that no action was necessary “based on available information.” This week, the agency declined to comment about the citizen petition.

Pediatricians, some of whom acknowledged in interviews that they were unaware of the drug-safety concerns raised by F.D.A. in 2009, said PEG had grown in use because it provides a no-fuss solution to constipation. Often a contributing factor is diet, like too much dairy and too few vegetables and fruits. Other factors include not sitting on the toilet routinely, stress, lack of hydration, being sedentary and school rules that discourage children from using the bathroom as needed.

Rather than tackling those factors, Miralax “can be a Band-Aid,” said Dr. Tricia Jean Gold, a pediatrician at TriBeCa Pediatrics in Park Slope, Brooklyn. When parents try to wean their children off Miralax, “the underlying work isn’t done, so they become constipated again,” she added.

Following a pediatrician’s advice, Mary, a Manhattan mother who asked to be identified only by her first name, started giving her daughter Miralax at 3 years old, when she defecated only every three to seven days, with many tearful hours in between.

“You’re begging her, promising her anything,” Mary said, adding that her child did eat broccoli and pears. Then came “the magic powder,” as she called it. A capful diluted in juice made her regular, but the problem returned when she tried to wean her off it.

After two years of sporadic use of Miralax, another pediatrician told her, “That’s not healthy.” She now gives her daughter, 5, half a capful every other day, and wants to stop using it.

Lillu Tesfa said she never felt comfortable giving her 18-month-old Miralax but did after her pediatrician suggested it. “I did read the label,” which says for adults and children 17 and over, said Ms. Tesfa, who is a contracts administrator for a government contractor in Arlington, Va. “When I brought this up with her, she said, ‘Oh no, don’t worry about it. It’s  completely safe. I’ve had patients on it for years.’ ”

She found a Yahoo group of more than 1,600 people who trade tales of what they believe are troubling side effects from PEG. Not taking any chances, Ms. Tesfa stopped giving Miralax to her daughter, and increased fiber and used lactose-free milk.

Studies of Miralax or PEG cite adverse effects no more severe than diarrhea and bloating. But there have also been no large long-term studies of the effects of PEG on children.

“It’s a drug we use long-term; it’s very effective, has a good safety profile,” said Dr. Samuel Nurko, the director of a center for gastrointestinal disorders at Children’s Hospital Boston. “I’m comfortable prescribing it even though it’s not F.D.A.-approved for children.” (Dr. Nurko has done research partially supported by the former maker of Miralax.)

The F.D.A., however, held the drug safety oversight meeting in 2009, with a neurologist as a guest expert, that raised questions about the perception that PEG is “safe because it is minimally absorbed from the stomach and intestines.” Instead, the board concluded, “little is known about whether absorption in children differs from adults, especially in children who are constipated, have underlying intestinal disease, or are very young.”

Dr. Leo Heitlinger, a pediatric gastroenterologist at St. Luke’s Hospital in Bethlehem, Pa., said doctors can often be complacent about drugs that were never approved by the F.D.A. for children.

“The dilemma among people who take care of kids is they are so used to drugs coming out and people sort of figuring out how to use it in kids, and not having quality studies, they are almost too willing to accept things without enough evidence,” said Dr. Heitlinger, who is a spokesman for the American Academy of Pediatrics, and the chairman of a group that educates pediatricians about gastroenterology issues.