Miralax: Harmful Habit-Forming Laxative

MiraLAX, a popular laxative medication, has come under scrutiny due to concerns about its potential adverse effects, particularly in children. The medication's active ingredient, polyethylene glycol 3350 (PEG 3350), has been linked to an array of neuropsychiatric problems, including tremors, tics, obsessive-compulsive behaviours, and aggression in children. While it is approved for adults, it is not labelled for use in individuals under 17, yet it is commonly prescribed off-label to children, leading to public outcry. The presence of antifreeze ingredients and the lack of long-term safety data for paediatric use have further fuelled concerns.

Miralax is not approved for use in children under 17

Miralax is a popular over-the-counter laxative medication used to treat constipation. The active ingredient in the medication is polyethylene glycol 3350, or PEG 3350. It works by pulling water into the colon, which helps to bulk up and soften stool, making it easier to pass. While Miralax is commonly prescribed to treat constipation in children, it is important to note that it is not approved for use in individuals under the age of 17.

The lack of approval for pediatric use stems from concerns about potential side effects and the absence of sufficient data on the safety and effectiveness of PEG 3350 in children. In 2012, a citizen petition was filed with the FDA, urging an investigation into the long-term effects of PEG 3350 and its potential link to adverse psychiatric events in children. This petition prompted the FDA to initiate a study in 2014 to address these concerns.

The off-label use of Miralax in children has sparked controversy due to reports of behavioral changes and neuropsychiatric problems. Some parents have observed \"horrifying\" changes in their children who took the medication, including behavioral issues, speech problems, anxiety, mood swings, and aggression. These reports have led to increased scrutiny of the drug's safety profile in the pediatric population.

While the jury is still out on the definitive safety of Miralax for children, it is important to consult a healthcare provider before administering any medication to children under the age of 17. The recommended dosage and suitability of Miralax for a child experiencing constipation should be determined by a qualified healthcare professional.

It has been linked to severe neuropsychiatric problems in children

Miralax has been linked to severe neuropsychiatric problems in children, with parents reporting alarming behavioural changes in their kids after taking the medication. Parents have reported that their children have experienced mood and behavioural changes, including depression, anger, anxiety, mood swings, aggression, rage, paranoia, and even "near psychiatric events".

In 2012, a "Citizen Petition to Investigate Polyethylene Glycol 3350 Product Safety for Use with Pediatric Patients" was filed, urging the FDA to add a "black box" warning label to the medication pertaining to neuropsychiatric side effects in children. The petition also requested information on all clinical trials and studies conducted on polyethylene glycol (PEG) 3350 and demanded that the FDA conduct additional studies on its effects on children.

In response, the FDA deferred the submission of studies on the effects of Miralax on the pediatric population (those 16 years of age or younger) until October 2016. The FDA also required the manufacturer, Bayer, to submit annual reports on the progress of the pediatric studies, although it is unclear if these reports have been submitted.

The FDA did find traces of ethylene glycol (EG) and diethylene glycol (DEG) in eight batches of Miralax tested, which are ingredients found in antifreeze. However, the amounts were reportedly so low that they were classified as "acceptable". The FDA stated that "no action is necessary at this time based on available information".

In 2014, the FDA awarded a grant to the Children's Hospital of Philadelphia (CHOP) to investigate the possible side effects of Miralax. This study is ongoing and is specifically looking at PEG 3350, the active ingredient in Miralax. While the jury is still out, the study aims to provide more concrete answers about the safety of Miralax for children.

It is important to note that Miralax is not approved by the FDA for use in children, and the label advises against use for more than 7 days. However, it is commonly recommended off-label by pediatricians to treat chronic constipation in children, sometimes for extended periods of time.

It contains antifreeze ingredients

Miralax, an over-the-counter laxative, has been linked to severe neuropsychiatric problems in children, including tremors, tics, obsessive-compulsive behaviours, and more. Its active ingredient, polyethylene glycol 3350 (PEG 3350), is a compound that contains ethylene glycol, a chemical commonly found in antifreeze.

In 2008, the US Food and Drug Administration (FDA) tested eight batches of Miralax and found small amounts of ethylene glycol and diethylene glycol, ingredients in antifreeze, in all batches. These were deemed to be impurities from the manufacturing process. The tests were carried out because many of the adverse events reported were consistent with ethylene glycol poisoning.

The presence of ethylene glycol in Miralax is particularly concerning given that it is not approved for use in children. The FDA has only approved it for adult usage and even then, only for seven days at a time. Despite the FDA's findings and thousands of complaints from parents, no recall has been issued for Miralax, and the product remains easily accessible.

The potential dangers of Miralax are further exacerbated by the fact that it is often used for longer than the recommended period. Chronic constipation, for which Miralax is prescribed, stretches out the intestines, making them more porous and increasing the absorption of PEG. The softer and more permeable intestines of young children may also contribute to higher absorption rates, increasing the risk of adverse health effects.

While the FDA has not taken any action against Miralax beyond commissioning studies into its safety, the presence of antifreeze ingredients in the product is concerning and underscores the need for further research and caution in its usage.

It has been linked to kidney failure

Miralax has been linked to kidney failure (end-stage renal disease or ESRD). The drug's active ingredient, polyethylene glycol 3350 (PEG 3350), has been associated with oxalate nephropathy, a serious illness that can lead to renal failure. Renal failure occurs when the kidneys fail to properly filter waste from the blood, resulting in bodily swelling, loss of calcium, anemia, bone health issues, and an increased risk of heart disease.

In 2015, a lawsuit was filed against Bayer, the manufacturer of Miralax, alleging that the company failed to sufficiently investigate the effects of the drug on kidney function and did not acknowledge the potential side effect of kidney failure. The lawsuit was filed by Samuel Woniewala, a patient with pre-existing kidney disease who experienced abdominal pain and was diagnosed with oxalate nephropathy after taking Miralax for constipation for about four years.

The link between Miralax and kidney failure is particularly concerning for patients with kidney disease. Since at least 2009, researchers have been aware that Miralax is not safe for this population. However, the drug has continued to be prescribed to patients with kidney disease under the supervision of their doctors. This highlights the importance of fully investigating the potential side effects of drugs and providing accurate information to healthcare professionals and patients.

While the lawsuit against Bayer brings attention to the potential risks of Miralax, it is important to note that the drug has been studied and continues to be prescribed by some doctors. The balance between the benefits and risks of any medication is a critical consideration, and patients should always consult their healthcare providers before taking any medication, including over-the-counter drugs like Miralax.

It has been linked to obsessive-compulsive behaviour

Miralax, a popular laxative medication, has been linked to several adverse effects on children's mental health, including obsessive-compulsive behaviour. This off-label use of Miralax has sparked concern among parents and medical professionals, leading to a closer examination of its active ingredient, polyethylene glycol 3350 (PEG 3350).

Obsessive-compulsive disorder (OCD) is a mental health condition characterised by recurrent, unwanted thoughts, impulses, or sensations that drive individuals to engage in repetitive behaviours or compulsions. These obsessions and compulsions can significantly interfere with daily activities and social interactions. While everyone experiences occasional obsessions and compulsions, OCD is more extreme and disruptive to daily life. Individuals with OCD may spend hours a day performing rituals to ease their anxiety, and they are often aware that their thoughts and behaviours are problematic.

The link between Miralax and OCD-like symptoms in children has been reported by parents and is currently under investigation. Some parents have observed disturbing changes in their children's behaviour, including obsessive-compulsive behaviours, after they were administered Miralax. This has sparked concern and led to the formation of activist groups, such as the Facebook group "Parents Against MiraLAX (PEG 3350)," which aims to raise awareness about the potential dangers of the medication.

While the exact cause of OCD is unknown, several factors are believed to contribute to its development, including genetics, brain changes, PANDAS syndrome, and childhood trauma. The onset of OCD typically occurs during childhood, adolescence, or early adulthood, with an average age of onset being 19 years.

The controversy surrounding Miralax and its potential link to obsessive-compulsive behaviour has prompted further research and studies. The Children's Hospital of Philadelphia (CHOP) is conducting an FDA-grant-funded study to analyse the effects of PEG 3350 in children. The results of this study are highly anticipated and will provide valuable insights into the safety and potential side effects of Miralax use in the paediatric population.

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