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More than 2,000 families have warned the US Food & Drug Administration that Miralax may cause severe side effects in young children:
While this litigation is now closed, learn more from our lawyers including about a recent breast implant recall TV commercial.
Healthcare giant Bayer advertises Miralax, its popular over-the-counter laxative, as an effective treatment for constipation with “no harsh side effects.” Yet over 2,000 complaints to the FDA say otherwise, with shocking descriptions of patients, especially young children, suffering from kidney problems, seizures, psychiatric conditions, and other severe complications consumers blame on the drug. Has Bayer been keeping the public in the dark about Miralax side effects?
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PEG is produced and distributed commercially under the trade name Carbowax, and comes in a variety of sizes / lengths that exhibit unique properties useful in many cosmetic, food, and industrial applications. Typically, these size classes are named by the average molecular weight of the PEG molecule in question.
For instance, smaller PEG’s, such as PEG 400, which has a molecular weight of 400 grams per mole, are widely-used in cosmetics to help other ingredients penetrate more deeply into the skin. On the other hand, PEG 3350, the specific PEG used in Miralax, which falls somewhere in the middle of the size spectrum of PEGs offered by chemical manufacturers, doesn’t have this penetrative effect, and is used as a laxative precisely because it’s supposed to be very poorly absorbed by the digestive tract.
Jeanie Ward, co-founder of leading online support group Parents Against Miralax, has researched Miralax for nearly 2 decades trying to understand what the drug may have done to her daughter and countless other children who suffered ill effects after taking it.
Jeanie started giving Miralax to her daughter Nicole for treatment of constipation at her pediatrician’s recommendation. After just 10 days on the medication, Nicole, who was only three and a half years old at the time, suddenly exhibited dramatic personality changes, experiencing “near-psychiatric events” with uncharacteristic paranoid and aggressive behaviors, fits of rage, and other drastic mood swings.
As Jeanie continued to administer Miralax to Nicole through the years, unaware of any possible connections between the laxative and the frightening changes occurring in her daughter, the symptoms persisted, and Nicole still suffered from them by the time she was in 2nd grade. Nicole herself, who is now in her late teens, looks back on her childhood with pain and anger at how Miralax changed her from a “very, very happy child” to one fraught with disturbing, violent emotions. “I wanted to kill everybody,” she revealed in an interview with ABC News.
In 2001, soon after Jeanie Ward learned that Miralax could be the cause of Nicole’s behavioral issues, she petitioned the FDA for further research on the drug’s effects on children. Her pleas were largely ignored for about 8 months, after which an FDA Oversight Board Meeting was held. Though a number of concerns were raised in the meeting, the FDA initiated no new regulatory actions or research grants for Miralax at the time.
By 2012, Jeanie was prepared to try again. She teamed up with other concerned parents across the country to help author a new petition to the FDA, pressuring the Agency for a recall of Miralax. This petition was filed by the consumer advocacy nonprofit Empire State Consumer project.
The petitioners, in an extensive “statement of grounds,” informed the FDA that thousands of children are experiencing disturbing neuropsychiatric effects after taking Miralax.
Many parents sent FDA adverse event reports and personal statements describing their children exhibiting frightening complications involving the nervous system:
A seizure is an abrupt surge of abnormal electrical activity in the brain that affects a person’s actions, reflexes, senses, or emotions while occurring. Seizures can be generalized (involving electrical impulses throughout the entire brain) or partial (localized in one part of the brain only) and there are many varieties of each type.
A well-known example of a generalized seizure is termed “Grand Mal,” which causes patients to become unconscious, stiffen up, and then suffer violent convulsions, ending in a deep sleep. Partial seizures are typically less dramatic to observe, though often no less disturbing to the sufferer.
One category of partial seizures is “simple sensory,” characterized by impairment of or abnormalities in one or more of the 5 senses. For example, some children on Miralax reported experiencing an odd sensation of “something dripping down [their faces].”
Tremors are unexpected rhythmic muscle movements that can’t be suppressed. They most often affect the hands, but can also occur in a person’s arms, legs, midsection, head, face, and vocal cords. Although tremors can be experienced by healthy individuals as a consequence of certain genetic conditions, they’re more commonly caused by adverse neurological events, such as stroke or traumatic brain injury. Tremors may also result from liver failure, drug / alcohol abuse, mercury poisoning, or thyroid problems. Just as with seizures, there are many different categories and types of tremors, which you can learn more about from the Tremor fact sheet on the National Institutes of Health website.
Tics are movements (motor tics) or vocalizations (vocal tics), often repetitive in nature, that an individual has a persistent urge or compulsion to perform. They’re not completely involuntary, as a person prone to tics can attempt to refrain from them, but the sufferer will often experience mounting discomfort while exercising this restraint and will eventually be unable to focus on anything else until he / she performs the tic again. Though scientists haven’t yet established definite causes of tics, many doctors believe that use of certain medications can lead to tic disorders, especially in children.
After administering Miralax, some parents have observed their children to show sudden unusual speech patterns or signs of impairment, such as slurring of words, excessive mumbling, and whispering at inappropriate times. Speech disorders can result from difficulties in processing or understanding language, from an injured voice box or vocal cords, or inability to control the muscles of the mouth, tongue, and throat—all of which may be symptoms of considerable damage to the brain or nervous system.
Psychiatric changes / complications comprise the other main category of Miralax side effects in children noted in the FDA petition:
The Miralax petition also mentioned another worrisome category of side effects revealed by FDA adverse reports — kidney complications:
Metabolic Acidosis. This is a general term for conditions in which the bloodstream harbors an excess amount of acid, either because too much acid is produced or because normal mechanisms for removing acids are impaired. One of the main ways the body regulates acid levels is through the kidneys, which can remove excess acid up to a certain point. Though some cases of MA are mild and relatively harmless, throwing off the acid-base balance crucial to countless processes in the body is dangerous and can lead to severe shock or even death.
Renal Failure. According to a Miralax kidney disease lawsuit filed by man in Philadelphia, the FDA has received over 30 reports of Miralax users experiencing “severe kidney injury,” including full-on kidney failure, as a result of taking the drug. Shockingly, some of these renal failure victims were young children.
Though the FDA flat-out refused to recall Miralax, it did agree that more studies on Miralax’s effects in children were in order. To remedy this, the Agency funded more major clinical trials for the drug, including a study on possible contaminants and their effects on children, in response to the petition’s assertion that many side effects experienced by Miralax users were similar to side effects of poisoning from ethylene glycol, a toxic byproduct of Miralax’s active ingredient that the FDA actually detected in a number of Miralax batches.
Miralax victims and their families as well as concerned healthcare professionals and consumer advocates wait anxiously for the results of the new Miralax studies and for the FDA’s response to the updated information they will provide. Many hope the FDA will put new regulations into effect regarding Miralax to protect consumers, if the studies show that the drug does indeed pose elevated risks to children.
Additional regulations from the FDA will also help current and future Miralax plaintiffs by strengthening their legal claims. However, many victims are taking action now by filing lawsuits, rather than waiting for further Miralax studies to be completed, as it’s nearly always better to file sooner rather than later, especially considering state “statutes of limitations” that impose deadlines on how long a consumer is permitted to file a lawsuit regarding a particular injury.
