Tomorrow is Allergan Aesthetic's annual Botox cosmetic day, aka National Botox Day. The manufacturer and its providers use this day to promote their brand, customer loyalty, and to "celebrate" their most popular anti-wrinkle product.
As men and women line up in droves to smooth any signs of aging before the holidays, how many of them know that the Food and Drug Administration, received reports of "systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins?"
In 2009, a "black box" warning label, the strictest warning given to a prescription medication was given to all botulinum toxin A products which required manufacturers like Allergan to state that using the product may cause life-threatening adverse events or death. However, thousands of women and men in injury support groups and online forums report that they were never given the black box warning. In fact, their providers stated that the use of the product is "completely safe."
Our team took some time to investigate why there is a narrative in the industry that is completely false, and found that an important document designed to inform the public about its ongoing safety reviews of Botox has been removed from the FDA's website, and archives despite its availability in other publications. We were able to gain access to this document by using internet archives.
We believe that the removal of this important communication about Botox's patient safety issues has provided an opportunity for industry professionals to discredit the black box warning label because they do not know how or why the labeling came to be.
The removal of this document has caused us to question the mission of the FDA, which is to protect the health of the public by ensuring safety, efficacy, and security of biological products, human drugs, medical devices, and more.
The report on February 8, 2008 discussed that the FDA received reports not only of systemic reactions and deaths following botulinum toxin treatment for both FDA-approved and unapproved uses (for a “variety of conditions using a wide range of doses,”) but also that the adverse reactions reported were suggestive of botulism.
The possibility of developing botulism after Botox treatment is the most highly debated adverse event in the cosmetic injection industry. The overarching narrative by providers is, "That can't happen, or I have never heard of that happening before." But, it has happened! It happened back in 2008 and it has happened to thousands upon thousands of people globally today.
If you spend any length of time in botulinum toxin injury support groups like our Botox Dysport (Side Effects) Support Group on Facebook, the overwhelming majority of group members suffering from systemic reactions, or clinical symptoms of botulism were told by their doctors, or medical providers the same, "That can't happen, or I have never heard of that happening before." Clearly, we have a major issue happening worldwide in informed consent and patient safety. The FDA knew about this patient safety issue, why is it that the doctors, nurse practitioners, manufacturer trainers and sales team members do not know?
In addition to the FDA removing a crucial important public document from view, we are also concerned that the current labeling for the product states that "there has been no definitive serious adverse event reports from distant spread of toxin effect" (aka botulism) of Botox with dermatologic use, treatment for blepharospasm, strabismus, or migraine. And yet, looking at the FDA's FAERs database anyone can publicly access reports of death following each indication listed above. Something does not add up here!
At Tox Safety there are two questions that we want everyone who uses or is currently considering using Botox or any other botulinum toxin drug on the market to ask:
Why was the informative document that was meant to be a commitment from the FDA to inform providers and the public about the ongoing safety of a biological product removed from their website and archives?
How is it that current labeling for the product states absolutely that there are no "definitive serious adverse event reports," when there ARE?!
The removal of this document is an immeasurable problem and serious lack of informed consent, patient safety and awareness! This unfortunate event has set the stage for the global and humanitarian crisis, in the status quo, that is - thousands upon thousands people who have or are suffering with clinical signs of botulism after Botox treatment lining up in emergency room departments only to be told that their severe adverse events of dysphagia (difficulty swallowing,) ptosis (drooping eyelids,) double vision, muscle weakness, difficulty breathing, slurred speech, flu-like symptoms and more, are "not from the Botox," that they had that day, on the day before, or the week before.
If you believe that you have suffered adversely from botulinum toxin treatment and have not received the help that you need, please know that you are not alone. Please click on our support tab for a link to our forum, Botox Dysport (Side Effects) Support Group, the largest international support system for Botox injury. We are happy to provide you with the help that you deserve and may need.
Below is the document that was removed from the FDA website and archives. To download and read your own copy, click below.
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