Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
As the complications with the over-the-counter (OTC) drug MiraLAX remain present, we have continued to monitor any developments in the research that is being conducted.
Previously, the CHOP study had reportedly been “suspended indefinitely” without much public knowledge as to why or when it may resume. An earlier article of ours from January 2018, "MiraLAX Pediatric Study on Psychiatric Side Effects Projected to be Completed in 2018" goes into more depth of what this study is, and you can see the timeline of events which have occurred up until the delay.
FDA and Concerned Population Push for Advance in Study
Part of our continuous monitoring has been maintaining communication with parents and members of the community who have been affected by, or are involved with, this issue.
To reiterate, MiraLAX is an OTC drug which is used to help with occasional constipation. Polyethylene glycol (PEG) 3350 is the active ingredient which is the subject that the MiraLAX complications are in reference to. You can get more detailed information about these adverse reactions from our May 2017 article, "Growing Concern About Reports of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX"
We understand that there has been communication involving the United States Food and Drug Administration (FDA), concerned parents and members of the community, and the United States Senator regarding the matter through legislative means.
Necessary Revision for Components of the Study
Within the CHOP study, there were to be two phases; the first being developing precise laboratory assays to measure several PEG 3350 metabolites. More information on PEG 3350 and the metabolites or "compounds" which it is comprised of can be found in our previous article from October 2018, "Inconclusiveness of MiraLAX Studies Leading to Frustration for Parents". The second phase is the main clinical study, where the goal is to see if there is noticeable amounts of the PEG 3350 or metabolites in the blood of children who take it for chronic constipation.
Apparently, the suspension of the CHOP study was due to developmental issues regarding the precise techniques for correct measurement of the PEG 3350 metabolites - in other words, the first phase of the study was not able to be completed, which suspended the second phase.
This recent communication involving the FDA emphasizes the cruciality of establishing the appropriate techniques for detecting and measuring PEG 3350 and the related metabolites, so that there are reliable and meaningful results during the main clinical phase. Expert scientists within the Office of Pharmaceutical Quality have been requested to assist with this process.
Innovations for Reaching Large Audience
Additionally, it is our understanding that there is an investigative podcast in the works which will interview parents and members of the community who are directly affected by this issue, as well as provide insight and updates on developments within the study of this drug. If you are familiar with podcasts, you can understand how sufficient this technique is for delivering information to a large audience with the ability to put out new information whenever desired. If you are not familiar with them, and you are curious to know more about the MiraLAX situation, this would be a great opportunity to hear from knowledgeable, involved people.
When the podcast becomes active, we will be sure to share information as to how to listen to it. Accordingly, if and when we are aware of any advancements in the CHOP study or new information for the MiraLAX situation in general, we will continue to keep our audience as informed as we are.