Miralax has been linked to serious psychiatric symptoms in children. Thousands of families have notified the FDA of these potential side effects, spurring the agency to fund a new study on the laxative’s alleged complications.
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Miralax, an over-the-counter laxative commonly used to treat chronic constipation in children, is frequently promoted in print and TV ads as safe and effective. But what you won’t learn from any Miralax TV commercial is that the drug is causing children a number of severe unexpected side effects, including seizures and extreme psychological disturbances, according to a large volume of patient complaints to the FDA.
Though Miralax is widely-recommended by pediatricians for long-term treatment of childhood constipation, such usage is not actually supported by the FDA. The only FDA-approved indication for Miralax is short-term use (for up to 7 days) by adults (individuals 17 years and older).
This fact in itself is not alarming, as it’s actually quite common for doctors to recommend or prescribe off-label drug applications if they believe them to be a safe and fitting solution for an individual patient’s needs. But naturally, many physicians rely on drug labeling and informational brochures from the manufacturer to gauge a medication’s safety and efficacy, their busy schedules often preventing them from looking any further into published safety data. After all, drug manufacturers have a responsibility to properly inform the medical community and the public of product risks—so doctors and other healthcare professionals should be able to trust information provided by them.
However, this can prove disastrous for patients in cases where drug companies fail to disclose all known side effects, either by accident due to simple negligence, or by design because they feared full disclosure would negatively impact sales. Sadly, as seen in countless defective drug litigations in which corporate defendants were charged with “failure to warn” and other misdeeds, some drug manufacturers value their bottom line more than their commitment to uphold public safety.
Since Miralax is advertised as especially safe, with many clinical trial participants experiencing few or no side effects, pediatricians tend to consider the drug innocuous enough for children to tolerate on a long-term basis. Yet the FDA has received more than 2,000 adverse event reports over serious Miralax side effects in children, such as:
None of these side effects were ever mentioned on Miralax labeling, promotional materials, or informational brochures. Thousands of parents, devastated by such disturbing. unexplained behavioral and physical changes in their children, seek answers and support from online forums and social media—only to be shocked to learn for the first time that many other children on Miralax are suffering similar complications. Parents of victims describe their experience with Miralax as akin to “losing their child,” because the drug’s effects on the personality can prove so drastic.
After years of hearing countless heartbreaking personal stories of families harmed by Miralax, Parents Against Miralax, a leading online support and advocacy group for Miralax victims that has grown to over 15,000 members since it was established in 2002, decided to take a stand against Bayer by appealing to the FDA.
In 2012, the administrators and other members of Parents Against Miralax teamed up with the Empire State Consumer project, a consumer rights nonprofit organization, to advance a citizen’s petition to the FDA. The petition asked the Agency for a number of further studies and safety measures on Miralax, including an immediate recall that would allow for urgent warnings to be added to its labeling.
Though the FDA denied the demand for a Miralax recall, it granted some of the key requests put forth—in particular, several labeling updates and the call for more research into Miralax’s effects on children, patient reactions to long-term Miralax use, and the possibility of toxic contaminants in the drug.
However, the main study that the FDA funded to further examine Miralax use in children, conducted by researchers at the Children’s Hospital of Philadelphia, hasn’t been completed, and other proposed studies haven’t even started. Anyhow, results from these studies are coming far too late to help thousands of children who have been have already been adversely affected from taking the drug for extended periods, as instructed by physicians who were likely unaware of the potential risks.
Actually, according to pending lawsuits, it’s not only children who suffer from severe side effects of Miralax. Many adult patients say they’ve harmed by Miralax, particularly through kidney-related complications. The FDA has received over 30 reports of “serious kidney injuries” (such as renal failure) sustained by Miralax users, whose ages range from 5 to over 90 years old.
Though Miralax labeling does provide warnings about taking the drug if you have kidney problems, plaintiffs argue that these warnings are strong or specific enough to prevent consumer injury.
For example, Samuel Woniewala of Philadelphia, who filed one of the first kidney disease lawsuits against Bayer because he fell victim to a dangerous renal condition called oxalate nephropathy after taking Miralax, claims that the manufacturer “never made any reasonable effort” to properly inform the medical community of the “deadly risk” of developing oxalate nephropathy posed by Miralax. Woniewala believes the label’s instructions not to take Miralax with a history of kidney disease “except under the advice and supervision of a doctor” were rendered virtually useless by Bayer’s alleged failure to warn physicians of the risks.
Even though drug manufacturers are obligated to warn prospective users of all significant side effects of any medication they’re selling, so that they can make an informed choice on whether or not to take the risk of using the drug, sometimes manufacturers neglect or willfully avoid this responsibility, causing innocent patients to suffer needless harm.
So, it’s generally safest to be critical of advertising and other promotional materials for medications and to try to dig deeper before making the decision to start taking a drug, even with over-the-counter offerings, which are often perceived as less risky than prescription drugs. But the fact that consumers can attempt to do their own research doesn’t absolve drug companies of their duty, as part of the healthcare community, to thoroughly inform hospitals, doctors, and patients of risks.
After all, medical research papers are written for medical professionals and other experts in the field and thus can be challenging to comprehend for the average consumer. Another obstacle for consumers seeking published research on a medication of interest is that research papers are not freely available for public viewing. Most are viewable only through journal subscriptions, requiring monthly fees for each journal of interest or through a substantial one-time fee for each individual study.
In any case, patients are supposed be able to rely on their doctors to give them sound drug recommendations and safety information. But if doctors aren’t properly informed by drug manufacturers in the first place, how can they give reliable counsel to patients?
This is why most patients seeking legal action over Miralax injuries are filing product liability lawsuits against drug companies instead of filing medical malpractice claims against their doctors. These plaintiffs believe that their physicians couldn’t have reasonably known about the risks posed by Miralax based on the information provided by Bayer and the previous manufacturers of Miralax, and therefore should not be held liable.
In addition to these claims of failure to warn, plaintiffs and their attorneys say that Miralax’s manufacturers are guilty of:
If Bayer is indeed responsible for causing harm to Miralax users, then the company should be obligated to pay compensation to the victims, either through settlement or court order. Plaintiffs in drug suits commonly ask for over $70,000 in relief, depending on the severity of their injuries.