When Clinical Trials Turn Deadly: The Hidden Story Behind Pediatric Botox

There’s a truth buried deep inside the clinical trial system and it’s one that pharmaceutical companies would rather you never uncover. This truth plays a significant role in Botox’s story. But unfortunately, most people only know Botox as a wrinkle-smoother, or a quick lunchtime cosmetic fix. The truth is that behind the brand is a pharmaceutical product powerful enough to paralyze muscles, and in some cases, end lives.

This is the story Allergan doesn’t want us to tell. A story about children, clinical trials, and a truth buried beneath corporate silence.

Botox Was Tested on Children with Cerebral Palsy

In pursuit of FDA approval to treat lower limb spasticity in children with cerebral palsy, Allergan sponsored multiple clinical trials, including the long-term safety study  NCT01603641. Clinical trials took place even after Allergan's 1994 internal studies on cynomoglus monkeys that resulted in animal fatalities. For more read our article (HERE) that outlines the results from this horrific animal study. AND, NCT01603641 took place after Allergan released in 2008, Botox Onabotulinumtoxina Special Analysis: Pediatric Fatal Outcomes, where 13 child fatalities documented were similar doses to what the monkeys received. But nope, these results apparently weren't good enough, and they fatally poisoned MORE children.

Long-term safety study, NCT01603641 was no rogue experiment, or “black market” scenario. It was a multi-center, regulated, fully funded, open-label trial where children as young as 2 received repeated Botox injections for over a year. Again, this was a trial under regulatory oversight!

The goal was to expand Botox’s medical indications, and its profit base. But the results AGAIN were devastating. Further, these deaths are referenced in broader systematic reviews of pediatric botulinum toxin trials, it is NOT just this single one. The trial above was part of that pool.

More Children Died

Multiple pediatric deaths occurred during and after botulinum toxin trials. The causes? Most frequently, respiratory failure, a known complication when botulinum toxin spreads beyond the injection site and interferes with muscles needed to breathe or swallow.

These deaths were not isolated. In a  systematic review of pediatric Botox use, researchers documented four deaths among more than 6,300 children treated with botulinum toxin.

And while no single death was publicly attributed to a specific trial by name, the FDA was concerned enough to require warnings and push back against unproven pediatric use.

Allergan’s Response? Silence and Withdrawal

Instead of addressing the harm publicly, Allergan quietly withdrew its application for FDA approval for pediatric use of Botox in cerebral palsy.

No headlines. No public reckoning. No press release. You can find the withdrawal mentioned only in regulatory documentation,  such as the FDA's summary review of later adult approval, buried in technical language and footnotes. (Source)

The FDA’s Response?

The FDA's internal review acknowledges potential distant toxin spread as a major safety concern. (Source)

The FDA placed a boxed warning on Botox highlighting the risk of toxin spread from the injection site, causing serious effects such as muscle weakness or respiratory compromise. (Source)

EVERYONE should have asked for Allergan’s transparency, but it NEVER happened.

The fact remains that results for NCT01603641 have not been publicly posted. LOOK at the trial with your own eyes. Do you SEE what we SEE? The amount of data, BLACKED out. Like it also, NEVER happened. Now, NO ONE knows the full rationale behind Allergan’s decision to withdraw approvals for pediatric cerebral palsy or the details of the fatalities, which remain obscure in peer-reviewed platforms only.

And yet, the same product continues to be touted as a savior. It is not just used off-label in children with CP, but these children's parents are even pressured into using it! See a recent example from a parent who recently contacted us at Never Tox.

Message to us at Never Tox on Instagram, 7/2025

What’s Off-Label Use?

“Off-label” means a doctor can legally prescribe or administer a drug for a use that hasn’t been FDA-approved,  even in children.

Botox is often used off-label in pediatric neurology, despite the lack of FDA approval and the documented risks of distant toxin spread, muscle weakness, and life-threatening respiratory events.

Families are rarely informed that:

• The FDA did not approve Botox for CP in children, as of Dec. 2019 (Source)

• Clinical trials ended in tragedy.

• The manufacturer quietly stepped away from pediatric use, pulling their pediatric FDA-approval request. (Meanwhile, they repeated the study with stricter exclusions, produced a different result and reapplied for approvals as if nothing wrong had ever occurred.)

  
  

People, this is not informed consent. It’s omission by design and it is happening ALL. THE. TIME.

The Bigger Lie: “It’s Only Dangerous If It’s Black Market”

This tragedy didn’t happen in an unlicensed medspa or unqualified office. It happened under strict regulation. In hospitals. With Allergan’s product. In FDA-registered trials.

The lie that only “bad Botox” harms people is not just false, it’s dangerous. It silences victims, protects the brand, and puts more lives at risk.

These Children Deserve More Than Silence

The children who died in these trials are not footnotes. They are not anomalies. They are victims of a system that prioritizes market share over transparency.

We remember them. We speak for them. And we fight so no parent is ever blindsided by the risks of a product marketed as safe.

If this is the first time you're hearing this, that’s not an accident. Please help spread the word, we need all the help we can get bringing this truth to light. 

Help by:

Sharing this post. (For the LOVE, please credit us.)

Telling someone.

Asking needed questions.

Because silence protects money and power. Let’s all work together to help to protect people.

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