Rudy Freno
Is It Safe To Take Miralax Everyday – Since it was first introduced 13 years ago, a drug called Miralax — an odorless, tasteless laxative that dissolves easily 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 is far from its original purpose. The drug is approved by the Food and Drug Administration for adults only and for seven days only.
Is It Safe To Take Miralax Everyday
Instead, Miralax has become a long-term solution to childhood constipation — a problem that can be not only physical but emotionally distressing — rather than a short-term solution for parents to change their children’s diets to include more fruits and vegetables.
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“I had children for years every day,” said Dr. Scott Cohen, a pediatrician in Beverly Hills, California, who added that he usually refers them to a specialist for chronic cases. For children with chronic constipation that doesn’t respond to dietary changes, “we literally treat it like water.”
No studies have shown that the drug’s active ingredient — polyethylene glycol 3350, or PEG, has any serious 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 who have been concerned about the so-called PEG for the past decade.
Miralax’s warning label does not indicate a known risk to children. This means that long-term studies that meet FDA standards have not been conducted in children using Miralax and its generic counterparts, which work by injecting water into the colon. However, discussion groups on many websites indicate that thousands of parents have questions and concerns about it, including the effects of long-term use.
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In interviews, more than a dozen doctors across the country, including pediatricians and gastroenterologists, said they routinely see young patients treated with Miralax for months and years. Many doctors have long advocated the use of PEG to treat childhood constipation.
Said Dr. Leo Heitlinger, a pediatric gastroenterologist, that doctors may be happy with drugs that were never approved for children. Credit… Aaron Houston for the New York Times
Dr. Dean Focht, a pediatric gastroenterologist at Geisinger Medical Center in Danville, Pa., knows about the popularity of Miralax in recent years. He was the lead author of a 2006 peer-reviewed study, when it became an over-the-counter drug, that found 75 percent of 350 pediatricians nationwide recommended Miralax or similar generics. to parents to treat child constipation.
Dr Focht said he is seeing more children taking it for longer periods, although the label warns that it should only be used for seven days and that parents should consult a doctor before children without 17 years old to treat. “Not really. It’s not unheard of for kids to have it for years,” Dr. Focht said.
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Despite the drug’s popularity, it was not approved by the F.D.A. For child use. In 1999, when the F.D.A. When Miralax was first approved, the patient material included the warning: “Miralax should not be used by children.” In 2009, the FDA’s Drug Safety Review Board raised several concerns about the use of PEG in children, including uncertainty about the long-term effects of large doses, but concluded that the available evidence does not show that the sub-PEG leads to serious consequences.
However, some doctors have expressed concern 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, chief of Gastroenterology at Nationwide Children’s Hospital in Columbus, Ohio.
However, said Dr. Di Lorenzo, who once funded research at the company that made Miralax before Merck, is concerned. “As far as we know, polyethylene glycol is safe,” he said.
In a statement, Merck said it recommends using Miralax only in patients over 17 years of age and only for one week, adding that it “regularly reviews and reports all adverse event information as part of our ongoing post-marketing surveillance”. A question was asked if the FDA plans to conduct studies. Approval for child use, the company refused.
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After a drug administration meeting in 2009, the F.D.A. He concluded that no action was required “based on the information available”. This week, the agency declined to comment on the citizens’ petition.
Pediatricians, some of whom admitted in interviews that they were unaware of drug safety concerns raised by the F.D.A. It was stated in 2009 that the use of PEG has increased because it provides an easy solution to constipation. Diet, such as excess milk and lack of vegetables and fruits, is often a contributing factor. Other factors include not regularly sitting on the toilet, stress, lack of hydration, sitting, and school rules that prevent children from using the bathroom when necessary.
Rather than addressing these factors, Miralax “may be a band-aid,” says Dr. Tricia Jean Gold, a pediatrician at TriBeCa Pediatrics in Park Slough, Brooklyn. When parents try to wean their children off Miralax, “the main job isn’t done, so they get stiff again,” he says.
Following her pediatrician’s advice, Mary, a Manhattan mother who asked to be known only by her first name, began giving her daughter Miralax at age 3, when she voided once every three to seven days, with him -including many tears at times .
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“Beg him, you didn’t promise anything,” said Mariam, adding that her son ate broccoli and pears. Then came the “magic powder,” as he called it. A regular diluted juice cap did it, but the problem returned when he tried to remove it.
After two years of occasional use of Miralax, another pediatrician told her, “It’s not healthy.” She gives her 5-year-old daughter half a cap every other day and wants to stop using.
Lilu Tesfa said she didn’t feel comfortable giving her 18-month-old Miralax, but did so after her pediatrician recommended it. ”I read the label,” said kids 17 and older, Ms. Tesfa, who is a contract administrator for a government contractor in Arlington, Washington. Oh, don’t worry about it. It is completely safe. I have had patients for years. “
He found a Yahoo group with more than 1,600 people trading stories about what they believed to be troubling side effects of PEG. Mrs Tesfa stopped giving her son Miralax, increased fiber and used lactose free milk.
Miralax Powder Laxative, 34 Doses, 20.4 Ounce
Studies of Miralax or PEG reported adverse effects that were no worse than diarrhea and bleeding. But there are no large long-term studies of the effects of PEG in children.
“This is a drug that we have been using for a long time; It’s very effective, it has a good safety profile,” said Dr. Samuel Nurko, director of the Center for Gastrointestinal Disorders at Boston Children’s Hospital. “I feel comfortable writing this even though it’s not approved by the F.D.A. for children.” (Dr. Nurko conducted research partially supported by the former manufacturer of Miralax.)
However, the FDA held a drug safety oversight meeting in 2009 that included a neurologist who questioned whether PEG was “safe because it is less absorbed from the stomach and intestines.” Instead, the panel concluded that “little is known about whether absorption differs between children and adults, particularly in children who are constipated, have underlying bowel disease, or are very young.”
Said Dr. Leo Heitlinger, a pediatric gastroenterologist at St. Luke’s Hospital in Bethlehem, whose doctors are often complacent about drugs not approved by the F.D.A. for children
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“The dilemma with people who take care of children is that they get used to the drugs that come out and the people who figure out how to use them on children and they don’t have quality studies, they’re almost ready to accept the things that are not enough evidence,” said Dr. Heitlinger, who is a member of the American Academy of Pediatrics and leads a group that educates pediatricians about gastroenterology issues.
A version of this article was printed in Section A, Page 1 of the New York edition under the headline: Medicine for adults is popular as medicine for children. Reprint Order | Today’s paper | Prescription use of multiple laxatives is associated with a 90% increased risk of dementia, findings
New research suggests that people who frequently use laxatives may have an increased risk of developing dementia later in life, which can be a side effect of products like Miralax, Ex-Lax and others. which promotes intestinal toxins.
Regular use of laxatives is associated with a greater than 50% increased risk of dementia compared to those who never used the drugs.
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Laxatives are medications used to relieve constipation, a common gastrointestinal disorder characterized by difficulty passing stool. There are two classes of drugs classified as heavy