Tics, rage and seizures those were some of the neuropsychiatric problems parents told 8News developed in their children after they were prescribed MiraLAX for their tummy troubles.

Now, 8News has uncovered some of the same side effects are being reported by adults.

Through a Freedom of Information Act, request 8News has combed over the detailed copies of the more than 20,000 complaints about MiraLAX filed with the FDA.

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We found a seizure reported in a 43-year-old woman. A 25-year old male who suffered a seizure and an 80-year-old female reported having a seizure after being on MiraLAX for just three days.

And that’s only three reports. 8News can see from the adverse event reports the FDA has gotten many more about adults suffering a seizure after taking MiraLAX.

We had heard about similar complaints in children.

Mike Koehler of Wisconsin told us his son suffered seizures while on MiraLAX for almost five years. His son’s doctor prescribed it for the child off-label.

“Ticks, and tremblings and just uncontrolled body movements,” he told us.

Norfolk resident Norma Eggleston also told us she believes MiraLAX made her granddaughter sick.

“She would have these uncontrollable tics,” Eggleston said.

As for the reports of seizures in adults, the FDA sent 8News the following statement:

“We continue to monitor adverse events associated with MiraLax and are aware of cases of seizures occurring in adults taking polyethylene glycol 3500, the active ingredient of Miralax.  In some cases, consumers reported experiencing a seizure after using larger quantities (e.g., entire bottles) than are currently recommended in the approved drug facts label (unapproved dose) for a bowel prep procedure (unapproved use).  Rapid fluid loss (e.g., due to frequent bowel movements, vomiting), intake of large volumes of fluid in preparation for a bowel procedure, and concurrent use of other agents such as diuretics can adversely affect electrolyte levels in the blood and cause serious adverse events such as seizures to occur.  We will continue to monitor and review cases reported to the FDA and provide updates to the public as new information is learned.

The FDA Adverse Event Reporting System (FAERS) is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer’s compliance with reporting regulations, and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers to monitor the safety of products marketed in the U.S. If a potential safety concern is identified in FAERS, further evaluation is performed.

FAERS data does have limitations. First, there is no certainty that the reported event was due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Additionally, reports are often duplicates or updates of previously reported events, and therefore, a raw count of reports may not accurately convey the number of unique events that have actually been reported to FDA. Furthermore, FDA does not receive reports for every adverse event that occurs with a product. Many factors can influence whether an event will be reported, such as the time a product has been marketed and publicity about an event. Therefore, FAERS data cannot be used to calculate the incidence of an adverse event in the U.S. population.”

The FDA has funded a study to determine if the main ingredient in MiraLAX, PEG 3350, is absorbed in our bodies. 

“They have not finished the study, so why are doctors prescribing it?” asks Eggleston.

 “It doesn’t cause dependence as some of the other laxatives do and that’s why we don’t shy away from using it,” says Doctor Flora Szabo, a pediatric gastroenterologist at Children’s Hospital of Richmond.  

Dr. Szabo told 8News they believe MiraLAX has been studied extensively. She says it’s been on the market for 60 years and believes it’s safe, even for kids.

“At the moment based on what knowledge we have, we fill good about recommending this medication to parents,” Dr. Szabo explained.

Bayer, the makers of Miralax, issued te following statement:

“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.

*PEG 3350 and PEG 4000.”