Botox Safety – Myth versus Reality

The sensational news reports from January 24, 2008—typical for the press—struck fear in the hearts of the Botox using community: Death from Botox!: In Wake of 16 Deaths, Advocates Urge FDA to Improve Botox® Warnings.

As always, though, the devil is in the details and those are conspicuously absent from these news articles. Based on the reports, none of these tragic deaths were among patients receiving Botox Cosmetic for their facial wrinkles. Rather, those who died were patients receiving injections on their neck muscles and vocal cords.

The American Society for Dermatologic Surgery has just released an e-mail which states that the single patient who was cited as the only patient who died from the cosmetic use of Botox actually died from complications of Staphlococcus pneumonia which had nothing to do with the Botox which was given seven weeks previously.

Botox (botulinum toxin type A) from Allergan is used for more than just wrinkles. For many years, and long before it was approved for cosmetic use, Botox was and is used for the treatment of muscle tension disorders, such as vocal cord spasmodic dysphonia and for a neck muscle disorder called cervical dystonia ("wry neck"). In both instances, Botox is injected into these hyperactive muscles to weaken them, generally to the suffering patient's great satisfaction.

The vocal cords most important function is protecting the airway (the windpipe and lungs) from food, liquids, saliva, etc., from going down the wrong way. But imagine the patient who's received a little too much Botox in their vocal cords during treatment for their voice disorder. As the paralysis kicks in, they become unable to protect their airway. This provides the perfect setting for conditions known as aspiration pneumonia or chemical pneumonitis from food, liquids, secretions, etc. getting into the lungs. These are potentially fatal complications.

In the situation where a child with cervical dystonia needs his or her neck muscles relaxed to relieve distorted anatomy resulting in a twisted neck, larger quantities of Botox are needed to relax these large muscles. But just fractions of an inch from it lies the esophagus though which we swallow. If enough Botox is injected around the esophageal or pharyngeal muscles of the throat, the resulting paralysis can make swallowing difficult or impossible. And where does that food go when it won't go down the esophagus? It obstructs the esophagus or spills into the airway, possibly choking the patient.

So, does that mean Botox is dangerous? Of course not. A death associated with Botox for reporting purposes does not mean Botox was the cause of death. For example, if a person got Botox then was unfortunately hit by a car, that death could be reported as Botox related.

Could Botox migrate from the forehead muscles, frown lines, or crow's feet far enough and in sufficient quantity to cause death? No! The lethal dose of Botox is estimated at about 3,000 units which is 30 vials. Typical cosmetic doses are about 5 to 40 units of Botox..(less than ½ a vial). — that is less than 1/60 of a dangerous dose.

There are thousands of drugs that 60 times the normal dose could be lethal, including plain aspirin. In fact over 100 people die every year from eating a peanut — the odds of a random person dying from eating a peanut is certainly greater than the odds of dying from getting a cosmetic Botox injection.

Additional points made by the ASDS:

• Botox® Cosmetic has been FDA-approved and in continuous use since 1989 with rare reports of adverse effects, most of which were minimal and transitory.
• In 2005, almost 575,000 Botox® injections were performed by ASDS members with no reports of deaths or other major complications.
• The patient whose death was linked to Botox® by Public Citizen did not have any symptoms of an adverse reaction after injection. Her death was from infectious pneumonia, seven weeks after the injection, and was not causal.
• Surgeons are aware of the potential of side effects of Botox® and thoroughly inform patients of them when administering the drug.
• The ASDS and surgeons are not aware of any deaths that have occurred as a direct result of the use of Botox® throughout the history of the product's cosmetic use.
• Many of the people who receive Botox® for non-cosmetic reasons have underlying health issues and co-morbidities that may also contribute to the adverse effects that were reported.
• The AERS database is intended to encourage physicians to report any drug reaction. A report of an event does not by itself mean that the drug caused the event; just that the event occurred after the drug was administered.
• In its petition, Pubic Citizen cites adverse effects culled from the AERS database over a ten year period, but explicitly states that "causality cannot be proved" with respect to these adverse event reports.