What Is The Best Over The Counter Laxative For Constipation – Since it was first introduced 13 years ago, a drug called Miralax—an odorless, tasteless laxative that’s 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 is very different from its original purpose. The Food and Drug Administration approved the drug only for adults and for seven days only.
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Instead, Miralax helps parents change their child’s diet to include more fruits and vegetables, instead of trying to prevent the long-term effects of childhood constipation, which can be physically as well as emotionally taxing, becoming a temporary solution.
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“For years, I’ve had babies every day,” said Dr. Scott Cohen, a pediatrician in Beverly Hills, who adds that he refers them to a specialist for long-term cases. “We literally give it like water” for children with chronic constipation that won’t help with dietary changes.
No studies have shown that the drug’s active substance – polyethylene glycol 3350 or PEG – has serious side effects. But questions are mounting as to why it has been used and prescribed to children for so many years.
Last week, for example, the Empire State Consumer Project, a New York-based consumer group, sent a petition to the F.D.A. In the last decade, so-called PEGs on behalf of concerned parents.
Miralax’s warning label does not reflect any known hazards to children. It simply means that long-term studies that meet FDA standards have not been conducted in children using Miralax and its generic counterparts, which inject water into the colon. However, discussion groups on many websites indicate that thousands of parents have doubts 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 regularly see young patients treated with Miralax for months and years. Many doctors have long agreed to recommend the use of PEG for the treatment of childhood constipation.
Pediatric gastroenterologist Dr. Leo Heitlinger says doctors may be happy with medications that are never approved for children. Credit… Aaron Huston for The New York Times
Dr. Dean Focht, a pediatric gastroenterologist at Geisinger Medical Center in Danville, has heard about Miralax’s popularity for years. He was the lead author of a 2006 study that found that when it became an over-the-counter drug, 75 percent of 350 pediatricians nationwide recommended Miralax or similar generics to parents to treat childhood constipation.
Dr. Focht said that while the label warns that it should only be used for seven days and that parents should consult a doctor before treating children under 17, she is seeing more children taking it for longer. “Not really. It’s unheard of for kids to be there for years,” says Dr. Focht.
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Despite the drug’s popularity, the F.D.A. never approved it. For pediatric use. In 1999, the F.D.A. When Miralax was first approved, the patient material contained 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 high doses, but available evidence suggests that PEG causes serious side effects. that it does not show
However, some doctors are concerned about the lack of data on long-term effects. “We don’t know what’s going to happen in 30 years,” said Dr. Carlo Di Lorenzo, chief of gastroenterology at Nationwide Children’s Hospital in Columbus, Ohio.
However, Dr. Di Lorenzo, who once conducted research funded by the company that previously made Miralax, Merck, is not worried. “We know that polyethylene glycol is safe.
In a statement, Merck recommended that Miralax be used only in patients over 17 years of age and only for one week, and will “routinely review and report all adverse event data as part of post-marketing surveillance.” When asked if the F.D.A. plans to conduct a study. Authorization for pediatric use was denied by the company.
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After a drug control meeting in 2009, the F.D.A. It determined that no action was required “based on available information.” This week, the agency has not commented on the public appeal.
Pediatricians, some of whom in interviews with the F.D.A. 2009 reported that the use of PEG has increased because it provides a problem-free solution to constipation. A diet with too much milk and too little vegetables and fruit is often a contributing factor. Other factors include: not going to the toilet regularly, stress, lack of hydration, sitting and school rules that prevent children from using the toilet properly.
Instead of addressing these factors, Miralax “can be a band-aid,” said Dr. Tricia Jean Gold, a pediatrician at TriBeCa Pediatrics in Park Slough, Brooklyn. When parents try to wean their children off Miralax, “the bottom line doesn’t work, so they get constipated again,” he added.
Following the advice of a pediatrician, Mary of Manhattan, who asked to be identified only by her first name, started giving her daughter Miralax at age 3, every three to seven days, including a few hours of bowel movements.
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“You don’t beg him, you don’t promise him anything,” Mariam said, adding that her son was eating broccoli and pears. Then, as he called it, “magic dust” appeared. A cap diluted in juice made it regular, but when he tried to remove it, the problem returned.
After using Miralax on and off for two years, another pediatrician told her, “It’s not healthy.” She now gives her 5-year-old daughter half a cap every day and wants to stop using it.
Lilu Tesfa said she never felt comfortable giving her 18-month-old Miralax, but did so after her pediatrician recommended it. “I read the label,” said Ms. Tesfa, who is a contract administrator for a government contractor in Arlington, Washington, which is written for children 17 and older. No, don’t worry. It is completely safe. I have been sick for many years. “
He found a Yahoo group of more than 1,600 people sharing stories about PEG side effects. Ms. Tesfa stopped giving her daughter Miralax, increased fiber, and used lactose-free milk.
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Studies of Miralax or PEG reported adverse effects that were no more serious than diarrhea and inflammation. But there hasn’t been much long-term research on the effects of PEG on children.
“This is a drug we use long-term; It’s very effective, with a good safety profile,” said Dr. Samuel Nurko, director of the Gastrointestinal Center at Boston Children’s Hospital. “Even though the FDA hasn’t approved it for children, I think it’s worth writing about.” )
However, the FDA held a drug safety review meeting in 2009 in which an expert neurologist “raised questions about the safety of PEG because it is poorly absorbed from the stomach and intestines.” Instead, the panel concluded, “little is known about whether absorption differs from that in adults, particularly in children who are constipated, have intestinal disorders, or are very young.”
Dr. Leo Heitlinger, a pediatric gastroenterologist at St. Luke’s Hospital in Bethlehem, said doctors often tell the F.D.A. He can be satisfied with medicines he has never approved for children
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“The dilemma for people who care for children is that they are so used to releasing drugs and people thinking about how to use them on children and not doing quality research that they are almost ready to accept something without sufficient evidence,” said American Pediatrics. Dr. Heitlinger is a member of the Academy and head of the team that educates pediatricians about gastroenterology.
A version of this article appeared in the New York edition, Section A, page 1: Medicine for adults is known as medicine for children. Reprint Request | Today’s newspaper Subscription
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