Is the medicine you are giving your children clinically proven to be safe for kids? Doctors warn that all too often pharmaceutical companies leave children out of studies. Now this is leading to questions from parents using an extremely common medicine.
Emily Deweerd’s daughter Koley struggled with constipation starting as a baby. Her mom took her to multiple doctors. Finally one recommended MiraLAX.
“I was like this is the answer I have been waiting for. It is something I can just give and it will help,” said Emily Deweerd.
It worked. She relied on the medicine. Then - when her daughter Koley was about three-and-a-half years-old her parents noticed she started having aggressive and obsessive behaviors. She insisted she have five blankets at bedtime, and they all had to be in a certain order. She would obsessively smell her hands and fingers 50 to 100 times a day.
Then Emily and her husband saw a post on-line about parents wanting to know if MiraLAX caused their children’s behavioral problems.
“I just looked at him and said, ‘Oh my gosh. All of this stuff that is happening to her might be from the MiraLAX’,” said Deweerd.
They started trying other products and took Koley off MiraLAX.
“Two days. Two days it took, and I noticed the hand-smelling was almost completely gone,” she said.
On the Parents Against MiraLAX Facebook page she found many others with similar stories. She can’t help but ask the question, Did MiraLaAX cause her daughter’s behavioral problems?
“What I can say in general is that, it is fascinating because gut biology and brain biology are strikingly similar,” said David Rosenberg, Chair of Psychiatry at WSU & Children’s Hospital of Michigan.
He is not Koley’s doctor, but says often children with digestive issues also have psychiatric issues. Some of the neurotransmitters in the body that regulate digestion also regulate your brain.
“Severe constipation and the underlying causes of severe constipation have robust associations with psychiatric and behavioral disturbances such as obsessive compulsive behaviors, aggressive behaviors, attention deficit, tremors and ticks,” said Dr. Rosenberg.
He says it is hard for doctors to determine whether an underlying issue or MiraLAX causes such behavioral problems because, while it is often recommended for children, MiraLAX is not FDA approved for children. On the label it says it is intended for use in people over 17, unless a doctor advises otherwise. There simply has not been enough testing to determine possible side effects in children for the label to advise otherwise.
It is a problem doctors say they see with drug after drug. Testing all too often stops after a drug for problems children suffer from too is approved for adults.
“Children are the diagnostic and therapeutic orphans of American health care. They get short shrift in this system, and hence you have concerns like this,” said Dr. Rosenberg.
An FDA study has been started that could bring answers as to how MiraLAX impacts children, but there are many more drugs being used for years for children- without FDA approval.
MiraLAX released a statement saying:
“The health of our consumers is the top priority of Bayer’s Consumer Health division.
MiraLAX® is an FDA-approved over-the-counter (OTC) osmotic laxative that treats occasional constipation. MiraLAX OTC labeled dosing applies to individuals 17 years and older for up to seven days. Consumers are directed to ask a doctor about use longer than seven days or in children 16 years of age or under.
The active ingredient in MiraLAX, PEG 3350 (polyethylene glycol 3350), has a well-established, favorable safety profile confirmed by published studies and systematic reviews as well as a long history of safe use when taken according to labeled instructions.
Additionally, key published scientific reviews and other relevant publications of PEG-based laxatives* consistently conclude that they are safe and effective in children with a history of constipation. Evidence-based clinical guidelines also recommend PEG-based laxatives for children.
As part of Bayer's ongoing commitment to consumer well-being, we regularly track and analyze all adverse event data reported for our products and submit the information to the U.S. Food & Drug Administration (FDA). Results of this ongoing monitoring support the continued safe use of MiraLAX.”