gastrointestinal health

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Miralax Dilemma: As Common Laxative Studied, Parents Ask, ‘Is It Safe?’

Miralax is seen on a store shelf. (Robin Lubbock/WBUR)

Miralax is seen on a store shelf. (Robin Lubbock/WBUR)

By Ricki Morell

If you, like millions of parents, routinely give your child Miralax for constipation, recent reports that the Food and Drug Administration is studying a possible link between the common laxative and neuropsychiatric problems probably sounded scary.

After years of complaints from activists, two Children’s Hospital of Philadelphia researchers are now leading an FDA study of the ingredient — polyethylene glycol 3350, or PEG 3350 — to see how it affects children.

“We’re pleased that they’re going to be looking at behavior changes because that’s never been done before,” said Carol Chittenden, co-director of The Empire State Consumer Project, a nonprofit consumer group in Rochester, New York, that pushed the FDA to embark on the study. “Parents are feeling anxious but also validated because they’ve been telling their doctors for years about these symptoms.”

Just because the FDA is doing a study, doesn’t make it dangerous.
– Dr. Samuel Nurko

Miralax is sold over the counter as an adult laxative, but pediatricians and gastroenterologists routinely prescribe it to infants, toddlers and older children. And they often prescribe it for long-term daily use for chronic constipation, even though the label says it should be used for no more than seven days “unless advised by your doctor.”

Dr. Samuel Nurko, director of the Center for Motility and Functional and Gastrointestinal Disorders at Boston Children’s Hospital, said parents have little reason to worry. Dr. Nurko, who was involved in previous studies of Miralax, some partially funded by the drug company that used to own Miralax, argues that the drug isn’t approved for children because of the technicalities surrounding the FDA study process. He believes Miralax is safe for children.

“Just because the FDA is doing a study, doesn’t make it dangerous,” Dr. Nurko said. “From my perspective, the risk of not treating constipation is worse. Do you think the FDA would leave it on the market if it were dangerous? I think it’s an overreaction but I’m glad that they are studying it.”

About 5 percent of children suffer from constipation, according to the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, which has guidelines for long-term use of Miralax among other constipation treatments.

FDA spokesperson Andrea Fischer said in an email that the agency is funding the $325,000 study to explore pediatric safety concerns even though “the FDA has not determined that there is enough data to warrant additional warnings regarding these products, or to issue specific warnings about pediatric use of the drugs at this time.”

The FDA first tested Miralax in 2008 and found small amounts of ethylene glycol and diethylene glycol, toxic ingredients also found in antifreeze. In subsequent tests in 2013, it found no detectable levels of those ingredients.

Chittenden says any hint that PEG can lead to side effects known to be associated with ethylene glycol or diethylene glycol toxicity is disturbing. According to a 2009 FDA drug oversight report, neuropsychiatric side effects “may include seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia and mood swings.”

Diethylene glycol toxicity can also cause “metabolic acidosis,” or too much acid in the blood, which, in severe cases, can lead to shock or death.

But Fischer emphasized that the link between these side effects and Miralax is so far unproven. Continue reading

MIT Lab Hosts Nation’s First Stool Bank, But Will It Survive?

Bottles of frozen human stool for fecal transplants at the nation's first stool bank, OpenBiome. (Photo: Gabrielle Emanuel/WBUR)

Bottles of frozen human stool for fecal transplants at the nation’s first stool bank, OpenBiome. (Photo: Gabrielle Emanuel/WBUR)

You walk through a labyrinth of MIT buildings and into what looks like a typical laboratory: white walls and clean counters, the constant buzz of machines, the clutter of pipettes. In the corner, you open the door to a hulking freezer.

When the puff of frosty air clears, you see stacks of plastic bottles filled with what looks a little like smoothies — in tawny, rusty colors Odwalla would never market. That’s your first hint of this lab’s unique purpose. Then there’s the giveaway: on the sterile countertop, you see a trophy of a squatting muscleman, labeled “Most Generous Donation.”

Welcome to the first national stool bank. It’s like a blood bank, but for fecal matter. And that brown smoothie is actually very healthy stool, parasite-free and loaded with happy bacteria.

In early October, the stool bank — called OpenBiome — started shipping these bottles around the country. Once that FedEx box of dry ice and stool arrives at the hospital, the doctor can do a fecal transplant — which is exactly what it sounds like. You take a healthy person’s feces and put them into a very sick person’s gut. And if all goes well, a few hours later that sick person is much better.

America is just beginning to develop a stomach for this procedure — it’s gaining popularity among patients and doctors. And by all accounts the stool bank has made things much easier. But there is a chance those stool shipments will come to an abrupt halt.

Late last week, the FDA released a draft of its new fecal transplant guidelines. As they are worded, things don’t look good for the OpenBiome stool bank.

The FDA is thinking about requiring the patient or the doctor to personally know the donor. But that doesn’t work so well for the stool bank, where the donations come from “Donor One” and “Donor Two.” They are anonymous gifts and soon that might not be allowed.

The Ecosystem In Our Gut

But, first things first, why are we even talking about poop transplants? Continue reading

Psychobiotics: Can Stomach Bacteria Change Your Brain?

The plot keeps thickening when it comes to the connection between your gut and your brain.

A new review article links probiotics to changes in mood and mental health, suggesting these “good” bacteria might have potential as a treatment for depression and other psychiatric maladies. In the study, published in the journal Biological Psychiatry, researchers define the term “psychobiotic” as “a live organism that, when ingested in adequate amounts, produces a health benefit in patients suffering from psychiatric illness.”

(diditalbob8/flickr)

(diditalbob8/flickr)

These organisms act on what researchers call the “brain-gut axis,” a biological network connecting the intestinal and endocrine systems to the spinal cord and regions in the brain that process stress, such as the HPA-axis.

Is all this plausible? Perhaps. Ghrelin, known as the “hunger hormone” and produced in the intestines, was recently found to play a role in the development of chronic stress. And stress in turn has been found to alter our microbiota. There’s growing evidence that there’s a special connection between the gut and the brain, and as one MGH psychiatrist said recently: “There is a neural feedback from the gut to the brain so chronic gastrointestinal distress can exacerbate anxiety or depression.”

Thomas Insel, Director of the National Institute of Mental Health, stated last December that how “differences in our microbial world influence the development of brain and behavior will be one of the great frontiers of clinical neuroscience in the next decade.”

Dr. Timothy Dinan of University College Cork in Ireland and the psychobiotic study’s lead author says that although the research conducted on humans is sparse, “the animal studies indicate that certain psychobiotics can change brain chemistry.”

Continue reading

Coffee And The Ritual Bowel Movement

I recently switched from caffeinated to decaf coffee. It’s done wonders for my sleeping and calmed my anxiety too. There is, however, one particular benefit from high-octane coffee that I deeply miss. Hint: It used to occur in my bathroom each morning.

morning coffee

Frankly, I would have been happy to keep this intimate joy of coffee-drinking to myself, but then I saw this post on Twitter and had to share. Here, Steven Chang, M.D responds to the question: “Why Does Coffee Make Me Poop?

If you notice that your daily coffee ritual is often accompanied by a timely bowel movement, you’re not alone. For some people this can be an inconvenience, but for others, coffee can be one way of keeping regular. Some coffee drinkers some will readily feel this gastrointestinal effect, some less so.

How Does It Work?

Researchers believe that the bowel-stimulating quality of coffee comes from caffeine and/or other substances contained within the coffee brew. Continue reading