Some of the fine print in literature about Botox injections can be pretty scary. Hello, death? I'm wondering if anyone who has received Botox for cosmetic reasons has died, or has this only happened in people who've used larger, off-label doses of Botox?
Are There Reported Deaths of People Who've Gotten Botox for Cosmetic Purposes?
Doctor Answers (12)
Botox death risk
I have not read of a single death from a Botox injection, but I guess if a large amount was injected into a vein, it could cause some issues.
Be careful when injecting the neck with Botox!
It is important to note that the relative potencies of the various botulinum toxin products differ significantly within the toxin types and brands (Botox,Dysport,Xeomin and Myobloc). The potency of botulinum toxin is measured in functional units that correspond to the calculated median dose that would kill a mouse when injected into the stomach. Clinical doses range widely depending on the size of the muscle to be treated, the degree of muscle weakness required, and the specific botulinum toxin product used (the potency expressed in Units or U is not comparable from one botulinum toxin product to another). Spread of botulinum toxin effects is dose and brand dependant. Large doses rarely ever employed in cosmetic use can cause a Botulism – like effect. Botulism is a serious bacterial toxin-mediated neuroparalytic illness whose onset is typically marked by things such as double vision (diplopia), inability to control or coordinate the muscles used in speaking (dysarthria), and/or difficulty swallowing (dysphagia)), followed by progressive descending muscle Weakness or paralysis that can lead to respiratory failure and death. The clinical use of botulinum toxin products presents the potential for iatrogenic botulism, which may be described as the appearance of one or more clinical manifestations of botulism that has the potential to be clinically serious. This is can and has occured with cosmetic use. Local extension of effect of the botulinum toxin into anatomical structures (nerves and muscles) adjacent (contiguous) to the site of injection may occur and is described in product labeling.For example, dysphagia (difficulty swallowing) is described in product labeling as a "commonly reported adverse event following treatment with all botulinum toxins in cervical dystonia. It also has been seen when botulinum toxin products have been injected into the neck at doses as low as 60 units of Botox.also informed . the BLA ( Biologic License Application )or drug companies for various toxin products must also have a Approved Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of these products outweigh the potential for serious risks associated with the lack of interchangeability among the various botulinum toxin products.
There is also a lack of uniformity in the terminology used to characterize this adverse events associated with use of botulinum toxin products. Clinical seriousness may be considered with unintended extension of the toxin's neuromuscular blockade effects to anatomical structures beyond the targeted treatment site, whether these structures are close or far from the site of injection. Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinumtoxin. However, weakness of adjacent muscles may also occur due to spread of toxin. On the other hand dysphagia or difficulty swallowing may also be a sign of distant spread of botulinum toxin effects when the agent is administered at a site other than the neck. This has been seen with a Myobloc (a type B toxin) in cosmetic doses and when large doses are used in everything from cerebral palsy to hyperhidrosis or excessive sweating,. The mechanism by which distant spread of the toxin effects occurs has not been well established. Patients must be aware of the reports systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Although current product labeling for Botox, Botox Cosmetic, Dysport and Myobloc contains a section advising physicians that patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects, including severe difficulty swallowing and breathing and respiratory compromise, after local injection of typical doses of botulinum toxin, there is literature suggesting that "similar, potentially life-threatening systemic toxicity from the use of botulinum toxin products can also result after local injection in patients with other underlying conditions such as those with cerebral palsy associated limb spasticity." Back to the question...are any deaths which have been linked to Botox related to the cosmetic form of the toxin—and Allergan, the makers of Botox, went on record earlier this year to dispute the claim that the death of a woman in 2004 was caused by Botox Cosmetic. "In fact, says the California-based manufacturer, a medical review of this actual case demonstrates that the patient passed away in the winter of 2004 from complications associated with staphylococcus pneumonia, not from the Botox cosmetic treatment the patient received seven weeks earlier." However come again Botox use can result in pneumonia so a careful review of this case and another reported to the LA Coroner strongly indicates that Botox Cosmetic injected into the neck can and has very very rarely resulted in death.
Botox cosmetic from Allergan has a proven high safety record
There have been cases in which providers have used non FDA approved botulinum toxin with serious complications. I am not aware of fatalities from cosmetic uses of Allergan Botox Cosmetic or Dysport from Medicis.
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As the others have mentioned, botox for cosmetic use is very safe. I've never heard of a death from it's use in standard cosmetic doses. The news stories about serious consequences of botox injection have been due to the use of much higher doses than normal or the use of non-FDA approved forms of the drug.
Death by Botox? Never heard of it.
I am unaware of Botox Cosmetic being the cause of death or even anything more serious that some untintended or asymmetrical weakness near the area of injection. The dose is really, really small and really, really targeted. Jillions and jillions of injections have been done and the safety margin of Botox is really, really, really high.
Dr. Prendiville mentions in his answer a case of a doctor injecting some form of botulinum toxin not meant for human use and getting himself and some friends some time on ventilators.
Remember, you get what you pay for in this field of medicine. I get offers from time to time for "Botox" really cheap from off shore distributors. Make sure your plastic surgeon does not succumb to such temptations for making a quick buck.
Deaths with Botox Cosmetic?
I am unaware of any deaths associated with Botox cosmetic, Dysport, or Xeomin (all form of Botulinum toxin type A used for cosmetic purposes), all of which are utilized in controlled, safe therapeutic doses. A number of years ago, a Physician on the East coast of Florida injected a form of research grade Botulinum toxin type A (not Botox) into his own face in addition to several of his friends. This misadventure landed the whole party in the ICU on ventilators. It is believed that each individual received tens of thousands of units, inducing clinical botulism. The average dose of Botox is about 20-60 units, which is very safe. Having performed this procedure thousands of times, I have never seen any serious complications.
Death after botox
First, you should understand that Allergan (the company that makes the stuff) distinguishes between Botox Cosmetic, which we use for facial wrinkles, and Botox which is used for functional issues like hyperhydrosis, torticollis, headaches, cerebral palsy spasm, and a hole host of other sites. Botox Cosmetic has not had any deaths. I am personally aware of only three times that significant problems hit the news cycle concerning Botox Cosmetic, and in each case, the practitioner got the medication from some bogus source. Each of those events also prompted an internal review of Allergan and their track record, and each time they came out without involvement or product danger. The drug continued with a clean record.
An interesting study just hit the news as well, which found that botox might exert some influence in muscles distant from the injection. But the truth is, the study was done in lab animals and may not translate to humans at all, and was found only to change a test behavior of the distant muscle without actually influencing it's overall function. In other words, much ado about nothing.
Botox is as safe of a drug as you can find right now.
No one has ever died, or for that matter suffered anything more than a temporary nuisance side affect from Botox Cosmetic. By a huge margin, the most dangerous part of getting Botox is the drive to the doctors office.
Risks of Botox
Botox and other FDA-approved alternatives (Dysport or Xeomin) are extraordinarily safe. I am not aware of a single death from use of Botox for cosmetic purposes. There have been a few cases of rogue doctors using fake Botox from China and elsewhere who got into trouble and actually gave botulinism to their patients because they injected uncontrolled amounts of toxin. In those cases, they did not use Botox. That is why you should only go to a reputable dermatologist or plastic surgeon for your treatment.
Botox Cosmetic Safety Record
As the panel member indicated, there are no reported cases of deaths related to the use of Botox Cosmetic. For medicinal use wherein adverse outcomes or an allegation that death was related to the use of medicinal Botox, the factors involved were high doses of product for therapeutic benefits wherein risks vs. benefits were considered, and patients had co-existing medical conditions that attributed to poor health or immunocompromised systems.
On a side note, the safety issue is imperative when consumers are tempted to seek out services based upon the cheapest price available. Always make certain that the product comes directly from the manufacturer (Allergan) and that treatments are always administered by a licensed Registered Nurse, Nurse Practitioner, Physician Assistance, Medical Doctor.