screaming boy
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A study being conducted by the Children's Hospital of Philadelphia is looking into claims made by parents that their children developed "neuropsychiatric problems" after consuming the over the counter laxative MiraLAX.

Parents have reported that their children became angry, aggressive and paranoid after taking MiraLAX with some saying that their children experienced "near psychiatric events" and mood swings.

The study is apparently being done at the behest of the FDA and being conducted at CHOP. The FDA maintains that there is not enough data to link PEG 3350 with serious neuropsychiatric issues in children.

And MiraLAX's manufacturerer, Bayer has released a statement that essentially falls back on the FDA approval of the medicine. But many parents are not convinced. In fact, it is not simply one or two families who are concerned about MiraLAX's side effects but an entire group that say the connection between negative psychiatric side effects and the consumption of MiraLAX are all too clear.

As WPVI-TV in Philidelphia reported,
The families say a doctor recommended a seemingly harmless over the counter laxative to treat their children's bellies, but the side effects, some say, were like a switch that was flipped and their once happy, laughing children, turned angry and dark.

"We saw a lot of the anger, a lot of the rage, a lot of the aggression," parent Mike Kohler said.

"Near psychiatric events with paranoia, mood swings, aggression, rage," parent Jeanie Ward said.

"I feel like my son was absolutely robbed of most of his childhood," parent Jessica Aman of Chester Springs, Pa. said.

"He had the rage, fears, phobias, anxieties," parent Sarah Locatelli said.

Jeanie Ward's daughter Nicole was placed on MiraLAX when she was just 3 1/2-years-old. Within ten days, she says Nicole turned manic, aggressive, and paranoid.

"It was horrifying to see my daughter change like that and to not come completely go back to normal," Ward said.

Nicole Oerkfitz is now 19 and lives in North Wales, Pa.

"I was a very, very happy child. When I was 2, I was running around playing. In second grade I started hating everybody. I wanted to kill everybody. I'm mad that this happened to me," Oerkfitz said.

[...]

Natalie Saenz from West Chester read that label, but like other parents, she trusted her doctor when he recommended MiraLAX for her daughter Mia for eight months.

"All of a sudden, she started having this weird ticks," Saenz said.
These families complained to the FDA and are leading a group of other families to sound the alarm. A petition started by Jeanie Ward resulted in the FDA study.

PEG 3350 (polyethylene glycol) is an ingredient in MiraLAX and is at the heart of the controversy.

MiraLAX is not approved for use in anyone under 17 years old, but doctors routinely prescribe it to infants and toddlers. Clearly, MiraLAX needs to be examined, but the history of the FDA is such that we have to question whether or not the study will be truly impartial. Regardless, we are anxiously awaiting the results of the study.