Our Philadelphia attorneys are investigating claims that the over-the-counter constipation relief laxative MiraLAX produced by Bayer has serious side effects when given to children. The group of parents believe their children developed neuro-psychiatric problems after taking the medication. If you were instructed by a doctor to give your child MiraLAX and your child experienced paranoia, mood swings, aggression and/or rage despite discontinuing the medication, please call our office at 800-590-4116 to speak to Jim McEldrew or one of our other trial lawyers about this matter.
What is MiraLAX?
MiraLAX is a stool softener with the ingredient PEG 3350. It is used as a treatment for individuals having difficulties with bowel movements as a result of constipation. Constipation occurs when stool moves slowly through the colon and too much water is removed. PEG is used in a number of products. In MiraLAX, it works to hydrate and soften stool so that it can pass through the digestive system.
MiraLAX in Children
PEG 3350 is approved by the U.S. Food and Drug Administration for use in adults for up to seven days. It does not recommend MiraLAX for children under the age of 17 or for long term use. Nevertheless, Miralax is frequently prescribed by doctors for use in children.
In 2011 and 2012, parents began contacting the FDA with concerns that their children experienced side effects when taking MiraLAX at the direction of their doctor. They reported neurologic or behaviorial symptoms after their children began taking the drug which in some cases persisted after discontinuing the medication. Empire State Consumer Project petitioned the FDA in 2012 to investigate the safety of the product.
The FDA funded a study of the medicine in kids at the Children’s Hospital of Philadelphia. The results are currently unavailable as the study is ongoing and no timetable has been released. CHOP has been investigating the potential side effects since 2014. The research grant documents into the use of polyethylene glycol in the pediatric population are available on the National Institute of Health website.
The FDA also found that eight batches of MiraLAX in 2008 had small amounts of ingredients used in antifreeze due to impurities in the manufacturing process.
MiraLAX contains warnings for several side effects already. These potential side effects include severe or bloody diarrhea, bleeding from the rectum, blood in stool, stomach pain, cramps, bloating, upset stomach, dizziness, and increased sweating.
The FDA study was prompted by reports of obsessive-compulsive behavior, tics and tremors in children using MiraLAX. In the media, parents have also identified suspected cases of paranoia, mood swings, aggression and/or rage.
Bayer, the maker of MiraLAX, was previously sued in 2015 by a patient alleging that he developed an acute kidney injury as a result of long term use of the over-the-counter laxative. McEldrew Young Purtell Merritt is not aware of the resolution of this lawsuit at this time.
To speak to a McEldrew Young Purtell Merritt attorney about a potential lawsuit against Bayer for side effects of MiraLAX, please call 1-800-590-4116.