Action News Investigation - Part I

Could a common over the counter medication be sickening kids?

That’s what a study under way at the Children’s Hospital of Philadelphia is trying to figure out.

A group of families approached Action News with disturbing claims that children have developed neuro-psychiatric problems after taking MiraLAX.

Action News has learned this medication is being regularly prescribed off label to infants and toddlers, when it’s not recommended for use to anyone under 17.

Information disclosed by the FDA shows what’s in this may have small amounts of the same toxic chemicals found in anti-freeze.

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.

Even though the label doesn’t recommend MiraLAX for children under 17 and limits use to seven days, the parents Action News spoke with say pediatricians prescribe it like water, and for extended periods of time.

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.

The families complained to the FDA and are part of a Facebook group with over 3,000 members where other families have voiced similar concerns.

Jeanie Ward also helped to author a petition to the FDA asking for a warning label and an investigation into MiraLAX.

It resulted in a $325,000 study of Polyethylene Glycol (PEG) 3350, an ingredient in MiraLAX, in the pediatric population.

“I think they are poisoning our children,” Ward said.

The study was awarded to CHOP after the FDA reported 167 adverse side effects in kids, 37 of those included neurological or psychiatric responses. They also noted “small amounts of ethylene glycol and diethylene glycol” in tests they ran. That is the same ingredients found in antifreeze.

The FDA tells Action News they “take the health and welfare of pediatric populations very seriously,” and believe the label “accurately conveys the risks.”

While the study is ongoing, they have determined there is “insufficient data to demonstrate a link between PEG 3350 and serious neuropsychiatric issues in children.”

After repeated attempts to speak with doctors at CHOP, the hospital says they can’t comment because the study is incomplete; they say they will submit their findings to the FDA.

“I trusted the medical community and they absolutely robbed me of part of my fatherhood,” Koehler said.

In the meantime, these parents are worried more children may be at risk. They are pleading with doctors and parents alike to stop using this powerful laxative in the sensitive small bodies of kids.

“It breaks my heart cause I know how I felt and I didn’t want anyone else to feel that way,” Oerkfitz said.

Bayer, the manufacturer of MiraLAX provided us a statement saying their dosing applies to adults and children over 17-years-old and only up to seven days, unless otherwise directed by a doctor.

FDA Response

The FDA takes the health and welfare of pediatric populations seriously. To date, the agency’s reviews of adverse event reports and medical literature indicate that the approved labeling for PEG 3350 products accurately conveys their risks, and additional warnings regarding neuropsychiatric issues in children are not warranted at this time. However, because many parents and physicians rely on these products to treat serious constipation, we have decided to fund research to better determine the benefits and risks associated with the use of these products in children.

The study is ongoing, but the agency believes that data from the CHOP study will help FDA balance the needs of two distinct constituents we serve: those who are concerned about the potential health effects on children who take PEG 3350 products, particularly those who use them chronically; and those pediatric patients and their parents who, in consult with their physicians, need safe and effective drugs to alleviate the often very serious complications associated with childhood constipation.

You can find the original grant notice here: http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-14-002.html

As identified on the Tracking Accountability in Government Grants System website (taggs.hhs.gov), award number R01FD005312 has been granted to the Children’s Hospital of Philadelphia (CHOP). Any additional questions pertaining to the ongoing study should be directed to CHOP.

Additional Information

First, it is important to note that over-the-counter products containing PEG 3350 are not labeled for use in pediatric patients (other than to direct parents to consult a doctor) or for extended periods of time. Even prescription PEG 3350 products, which are labeled for pediatric patients for certain indications, are only for short-term use. That said, the Agency realizes that some doctors and parents advocate for chronic use of over-the-counter PEG 3350 drug products in children.

Two separate reviews of the adverse event reports associated with pediatric use of PEG 3350 products, and a review of the medical literature between February 2009 through May 2013, did not yield clinically significant non-gastrointestinal adverse events. In other words, there are insufficient data to demonstrate a link between PEG 3350 and serious neuropsychiatric issues in children. And although routine testing of Miralax in 2008 showed trace amounts of EG and DEG in the product, the amounts were so low, they complied with internationally recognized safety standards, and were not present in subsequent testing.

So, while the FDA has not determined that there are enough data to warrant additional warnings regarding these products, or to issue specific warnings about pediatric use of the drugs at this time, the Agency is always very concerned about the health and wellbeing of pediatric populations, which is why the Drug Safety Oversight Board was convened to examine the issue in 2009 – a few months after the first batch of Miralax was tested – and why the Agency is now funding the pediatric study.

Additionally I refer you to the FDA’s response to the 2012 Citizen Petition from the Empire State Consumer Project, available at http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0566-0006

Children’s Hospital of Philadelphia Response:

“Researchers at Children’s Hospital of Philadelphia are conducting a study commissioned by the Food and Drug Administration on laxative-use by children. We cannot comment on studies that are incomplete, nor can we comment on a particular child’s circumstances. We will submit our findings to the FDA upon completion of the study.”

Bayer Response:

Bayer Consumer Health has a long history as a leader in the manufacture and marketing of a broad range of over-the-counter (OTC) healthcare products and nutritional supplements. The health of our consumers is our top priority.

The MiraLAX brand became part of Bayer’s OTC portfolio in the United States in October 2014 with the acquisition of Merck Consumer Care. MiraLAX is an osmotic laxative that relieves occasional constipation. MiraLAX was introduced as a prescription laxative in February 1999 and was approved by the FDA as an OTC medication in 2006. OTC labeled dosing applies to adults and children 17 years and older for up to 7 days, unless otherwise directed by a doctor.

While MiraLAX is not labeled for use in the pediatric population, there have been many clinical studies conducted with PEG 3350 in pediatric populations which have demonstrated safety for short and long term use in children with a history of chronic constipation.

As part of Bayer’s ongoing commitment to consumer well-being, we regularly track, analyze and report all adverse event data related to the use of the product. Results of this ongoing monitoring support the continued safe use of MiraLAX.

With regard to the clinical study in question, it is a government-funded study by the National Institute of Health being conducted by the Children’s Hospital of Philadelphia. As Bayer is not involved in the study, any inquiries should be directed to them.

For more news and updates to her investigations, be sure to follow Wendy Saltzman on Facebook.