What Is The Strongest Laxative – 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 common supplements have strayed far from its original intent. The Food and Drug Administration has approved the drug for use by adults only and for only seven days at a time.
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Instead, Miralax has become a long-term solution to constipation in children – a problem that can be not only physically but emotionally distressing – rather than a short-term solution for parents to change their children’s diets. children to include more fruits and vegetables.
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“I’ve had kids take it every day for years,” Dr. Scott W. Cohen, a pediatrician in Beverly Hills, Calif., adds that he will usually refer them to a specialist in long-term cases. For children with chronic constipation who are not helped by dietary changes, “we give them like water.”
No studies have shown that the drug’s active ingredient – polyethylene glycol 3350, or PEG – has serious side effects. But there is a growing chorus of questions about why it has been used and prescribed for children over the years.
Last week, for example, the Empire State Consumer Project, a New York consumer group, filed a citizen petition with the FDA. on behalf of parents concerned about the increasing number of so-called PEG-related adverse events that health professionals and consumers have reported to the F.D.A. in the last decade.
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Miralax’s warning label does not indicate a known hazard to children. It just means that no long-term studies that meet FDA standards have been done on children using Miralax and its generic equivalents, which work by drawing water into the colon. However, discussion groups on many Web sites indicate that thousands of parents have questions and concerns about this, including the effects of long-term use.
In interviews, more than a dozen doctors across the country, including pediatricians and gastroenterologists, said they regularly see young patients who have been using Miralax for months and years. Most doctors agreed that they recommended using PEG to treat chronic constipation in children.
Dr. Leo Heitlinger, a pediatric gastroenterologist, said doctors can get complacent with drugs that aren’t approved for children. Credits… Aaron Houston for The New York Times
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Doctor. Dean Focht, a pediatric gastroenterologist at Geisinger Medical Center in Danville, Pennsylvania, 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, which found that 75% of about 350 pediatricians nationwide recommended that parents use Miralax or similar medications to treat constipation in children.
Dr. Focht said he is seeing more children taking it long-term, even though the label warns that it should only be used for seven days and that parents should consult a doctor before treating children under 17. “It’s certainly not unheard of that children have been in this condition for years, “Dr. Focht.
Despite the drug’s popularity, it was never approved by the FDA. for children’s use. In 1999, when the F.D.A. Miralax was first approved, the patient kit included the warning: “Miralax should not be used by children”. In 2009, the F.D.A. The drug safety oversight board raised a number of concerns about the use of PEG in children, including uncertainty about the long-term effects of high doses, but concluded that current evidence does not suggest that PEG causes serious harm.
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Still, some doctors said they were concerned about the lack of information about its long-term effects. “We don’t know what will happen 30 years from now,” said Dr. Carlo Di Lorenzo, chief of the department of gastroenterology at Nationwide Children’s Hospital in Columbus, Ohio.
Still, Dr. Di Lorenzo, who once conducted research funded by the company that produced Miralax before Merck, isn’t afraid. “As far as we know, polyethylene glycol is safe,” he said.
In a statement, Merck said it recommends using Miralax in patients 17 years of age and older and for only one week, adding that it “reviews and reports all adverse event information as part of our ongoing post-marketing surveillance”. When asked if he plans to study to get an F.D.A. approval for children’s use, the company declined to say.
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After its 2009 drug administration meeting, the F.D.A. it decided that no action was needed “based on the available information”. This week, the agency declined to comment on the citizen’s request.
Pediatricians, some of whom admitted in interviews that they were unaware of drug safety concerns raised by the FDA. in 2009, stated that PEG has become increasingly used because it provides a less invasive solution to constipation. Often the contributing factor is diet, such as too much dairy and too little vegetables and fruit. Other factors include not sitting on the toilet regularly, stress, lack of water in the body, lack of physical activity, and school rules that discourage children from using the toilet when necessary.
Instead of dealing with these things, Miralax “can be a band aid,” said Dr. Tricia Jean Gold, pediatrician at TriBeCa Pediatrics in Park Slope, Brooklyn. When parents try to wean their children off Miralax, “the basic job isn’t done, so they get constipated again,” he added.
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On the advice of a pediatrician, Mary, a Manhattan mother who asked to be identified only by her first name, began giving her daughter Miralax at age 3, when she was only relieving herself every three to seven days, with many hours of crying. .
“You’re begging him, promising him anything,” Mary said, adding that her son ate broccoli and pears. Then came the “magic dust”, as he called it. A cap boiled in juice made him normal, but the problem came again when he tried to wean him.
After two years of regular Miralax use, another pediatrician told her, “That’s not healthy.” Now she gives her daughter, 5, half a cap every other day and wants to stop using it.
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Lillu Tesfa said she never felt comfortable giving her 18-month-old Miralax, but did so after her pediatrician recommended it. “I read the label,” which says for adults and children 17 and older, said Tesfa, who is a contract manager for a government contractor in Arlington, Va. No, don’t worry about it. It is completely safe. I’ve had patients with this for years.’ “
He found a Yahoo group of more than 1,600 people sharing stories of what they believe are troubling PEG side effects. Without taking any chance, Mrs. Tesfa stopped giving her daughter Miralax, increased fiber and switched to lactose-free milk.
Miralax or PEG studies do not report any side effects other than diarrhea and bloating. But there have also been no large, long-term studies of the effects of PEG in children.
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“It is a medicine we use for a long time; it is very good, it has a good safety profile,” said Dr. Samuel Nurko, director of the gastroenterology center at Children’s Hospital Boston. “I feel comfortable prescribing it even if it’s not FDA approved for children.” (Dr. Nurko conducted research supported in part by the former manufacturer of Miralax.)
The FDA, however, held a drug safety oversight meeting in 2009, with a neurologist as a guest expert, which raised questions about the view that PEG is “safe because it is absorbed less from the stomach and intestines.” Instead, the council concluded that “little is known about whether absorption in children differs from that in adults, particularly in children with constipation, colic, or very young children.”
Dr. Leo Heitlinger, a gastroenterologist at St. Luke in Bethlehem, Pennsylvania, said doctors often get complacent with drugs that aren’t FDA-approved. for children.
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“The problem of people raising children is that they are used to drugs that come out and people think about how to use them for children, and not having good studies, they are ready to accept things without sufficient evidence..,” said Dr. Heitlinger, who is a spokesperson for the American Academy of Pediatrics and president of a group that educates pediatricians about gastroenterology. Drug Overview and Key Differences | Conditions Treated | Effectiveness | Insurance Coverage and Cost Comparison | Side Effects | Drug Interactions | Advertisements | Frequently Asked Questions
If you struggle with hard stools, stools that are difficult to pass, and/or you go to the toilet less than three times a week, chances are you have constipation. Constipation is a very common problem in the United States, affecting 16 out of every 100 adults and 33 out of every 100 adults age 60 and older.
Dulcolax and Miralax are two popular FDA-approved laxatives used to treat constipation and irregular bowel movements. Dulcolax contains bisacodyl, a stimulant laxative. It works by increasing bowel activity to cause bowel movements.
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Miralax contains polyethylene glycol 3350, an osmotic laxative. It works by drawing water into the colon, which softens the stool and makes it easier to pass. Both drugs are known as laxatives.
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