Dr. Niamtu’s Weblog

….on cosmetic facial surgery

Dr. Niamtu appointed to Xeomin Teaching Faculty

xeomin

The introduction of Botox by Allergan in the 1990’s proved to be a paradigm shift in cosmetic surgery as it was a safe and easy treatment that worked and had no previous type of treatment.  Obviously Botox was the first and still the
most popular neurotoxin (now called neuromodulator) with millions of treatments all over the world.  Like any industry,
progress introduces competition and several years ago Medicis introduced their product Dysport which although not exactly the same drug as Botox, has the same results.  Dysport has caught on and is a popular option for some patients that prefer it to Botox for various reasons, one of them being it is a little less expensive.  Dr. Niamtu is recognized as a Key Opinion Leader (KOL) in cosmetic facial surgery and serves on the teaching faculty   Botox and Dysport.  In addition, he is the only Diamond Level Botox provider in Richmond and the largest solo injector in Virginia (he personally performs all injections).

Dr. Niamtu is proud to be a member of the Xeomin (Merz Aesthetics) teaching faculty.  He has recently returned from Berlin, Germany completing instructor training for Xeomin and also had the rare opportunity to tour the actual plant where Xeomin
is produced.  He, along with other Key Opinion Leaders in plastic surgery and dermatology, will be teaching Xeomin
injection techniques to physicians in the USA.

Xeomin is the third neuromodulator to be FDA approved in this country and will represent yet another option for patients seeking
improvement of facial wrinkles.  Xeomin has been used around the world for safe and effective treatment of facial wrinkles since 1995. Although all these products are technically known as botulinum toxin A, they all have slightly different chemical structures.  Xeomin is the first neuromodulator that is processed in a manner to eliminate a part of the molecule known as the accessory protein coat.  It is this protein that contributes to allergic reactions.  Users of Xeomin can expect the same results as Botox or Dysport although the initial price will probably be less.  Otherwise the products are administered the same and have the same results that last the same amount of time.  The number of units injected with Xeomin is compatible with Botox injections.

Dr. Niamtu is pleased and honored to be included in the international teaching faculty for Xeomin and is excited to be the first doctor in Richmond to offer this treatment in his practice. Consumers should be prepared for the release of more new neuromodulators that are in the FDA pipeline and just like the different fillers, the multiple neuromodulators will offer more options for patients.  For more information about Xeomin or cosmetic
facial surgery visit www.lovethatface.com

Joe Niamtu, III DMD

Cosmetic Facial Surgery

Richmond, Virginia

 

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November 10, 2011 Posted by | Botox, Minimally Invasive Cosmetic Facial Surgery, New Cosmetic Surgery Technology, Uncategorized, Xeomin | , , , | Leave a comment

Botox Customization and the Droopy Brow

The discovery of neuromodulators to treat hyperfunctional lines was the cosmetic shot heard around the world and ushered in the most popular cosmetic procedure in the world.  When I began injecting Botox in 1996, it was a pretty much unheard of cosmetic therapy and the “pretty poison” was only used by those early adapters.  Back in the day, patients wanted paralysis, plain and simple.  If I injected a patient and they had even minimal muscle movement, they considered it a failure and wanted a refund.  It was not hard (still isn’t) to pick out those patients with mask-like expressions from total upper facial paralysis.

Things have changed greatly in the past decade.  Botox (and now Dysport, and soon to be others) has become an everyday procedure and the fear from “the toxin” has diminished.  What has also diminished is the desire for patients to look “done”.  Contemporary cosmetic surgery patients desire the ability to retain positive animation while stopping negative animation such as scowling.  After being injected for years, most patients now have an appreciation for exactly what they want their Botox to do.  Whereas in the past, they came in for injection and said “do what you think I need”, now they come in with their own tailor made request of units and injection patterns.  Although this bothers some surgeons, I welcome this “Botox customization”; after all, we are here to please the patient.

It is now common for patients to stretch or disperse their Botox units to achieve what they want.  I also feel that the sour economy we have seen over the last several have added to this where patients are trying to get more for their buck.

The most common customizations I see are in the glabella and frontalis.  Whereas the traditional 5 point glabellar injection is still the most common treatment, numerous patients present and request a more central glabellar treatment because fear of “lowering their eyelids”.  The same thing has occurred in my practice with the frontalis.  First of all the frontalis was the second most requested treatment in my office for over a decade, but has fallen to number three with the lateral canthal regions (crow’s feet) now being second.  The main reason for backing off of the frontalis is the fact that when coupled with glabellar treatment, a significant loss of animation can occur.  Again “my eyelids get droopy” (the real truth about this later) is a complaint from aggressively treating both glabella and frontalis.  This trend has led to my frequently injecting the glabella and using “half the units” on the frontalis.

Cosmetic surgery patients are finicky, but when patients feel that they have “droopy lids” from Botox, they can become livid and rebellious.  Proportionately, it seems patients can get madder about this condition than most other “real” cosmetic surgery complications.

Patients must understand the pathology of the “droopy Botox brow”.  Botox cannot make extra skin, but it can prevent patients from elevating their brow.  Many females, especially those with excess lid skin, perpetually elevate their brows.  It is subconscious and they cannot help or control it, they simply spend their waking hours with their brows elevated.  Ask any surgeon who performs brow lifts and they will confirm that it is impossible to take a before picture on many women with their brows relaxed.  Herein lies the problem.  When patients with excess upper eyelid skin raise their brow (via the frontalis muscle) they have the appearance of having less excess upper eyelid skin because the skin is stretched.  In some cases, they can also see better as the obstructing skin is elevated, hence improving vision.  If these patients are aggressively treated with a neuromodulator and cannot elevate their brow, they notice the extra eyelid skin (usually about 3 days after injection while applying eye makeup) and can become quite upset.  They think that the Botox gave them extra skin (impossible) or that they have true upper eyelid muscular ptosis (extremely rare).  What they frequently fail to understand is that they are chronic brow elevators and now they cannot elevate to their preinjection level.  The picture below is of your truly.  Admittedly, I need blepharoplasty or a brow lift.  I am bald, so the brow lift is out the window and I am simply too busy fixing everyone else to have my own blepharoplasty.  In the top picture, I am raising my brow and I look better that the bottom picture with my brow relaxed.  This picture tells the story!

It is imperative (especially for novice injectors) to recognize patients (usually older females with excess upper lid skin) who may be at risk for the “low brow”.  In these patients, especially those who are getting Botox for the first time, it is best not to inject the glabella and frontalis at the same time.  If the patient has a low hairline, the glabellar injection can deactivate a good portion of the frontalis.  If the frontalis and the glabella are to be simultaneously injected, it is better to use only 10 units of Botox (or 30 units of Dysport) over the entire frontalis to lessen the effect.  Also a good idea on any person is to taper off the Botox units and injections over the lateral brow.  Having a good central effect with a lateral tapering effect will still allow brow elevation.

Unfortunately, we cannot reverse neuromodulators so an unhappy patient may be unhappy for several months.  Fortunately, the lateral brow elevations seems to return before all the toxin is worn off.   The inventor of a botulinum toxin reversal agent will be a wealthy man or woman!

My advice to novice injectors is to include discussion of the above in the consent and to treat lightly with the frontalis.  My advice to patients is to be conservative as more Botox can always be added and to realize they may be in need of a browlift or blepharoplasty.

To find out more about cosmetic facial surgery by Dr. Joe Niamtu in Richmond, Virginia, visit

http://www.lovethatface.com

Joe Niamtu, III DMD

Cosmetic Facial Surgery

Richmond, Virginia

April 25, 2010 Posted by | Botox, Brow Lift Surgery, Minimally Invasive Cosmetic Facial Surgery, Risks of Cosmetic Surgery, Uncategorized | , , | Leave a comment

The Changing Face of Botox: Patient Customization

Rarely do we see true paradigm shifts in cosmetic surgery.  Neurotoxins are certainly a prime example of a new technology that replaced previous treatments with increased safety and less recovery.

When Botox arrived in the early 1990’s the “pretty poison” caught on like wildfire and soon became the most commonly requested cosmetic treatment internationally.  In the early days, patients wanted paralysis.  It was not uncommon for patients to complain or return for touch up if even a slight amount of movement was present.  It got so you could walk down a busy street or turn on TV and tell exactly who was “Botoxed” and what areas were treated.  At that time, the most common areas requested for treatment were the glabella, frontalis and lateral canthus, in that order.

Over the past decade, much has changed in how patients desire animation.  Gone is the overt reated paralyzed mask look.  It is a rare patient that does not want some remnant of normal animation.  This is especially true for the frontalis (forehead) region.  Not being able to frown is rarely a problem as we can communicate anger or displeasure in so many ways.  Not being able to use the eyebrows to communicate, however, is a bigger problem.  The average patient desires the ability to raise the brows as we communicate so much (often silently) with the upper face.  Not being able to convey surprise, interest, skepticism (raising one brow), etc. is a setback for the contemporary patient.  Adding to this problem are females with dermatochalasis (baggy upper eyelid skin).  Many females are habitual brow raisers.  They raise their brows from the time they wake up till the time they fall asleep.  This is done in part to lessen the effect of the excess upper lid skin.  A patient with excess upper lid skin will look younger (less skin) when they elevate their brows.  If Botox or Dysport takes away the ability to elevate the brow, then the excess upper eyelid skin is much more obvious.  Getting a neurotoxin in the forehead (or neuromodulator, to be more contemporary) does not make extra skin, it merely prevents brow elevation thus causing the already excess skin to be more evident.  Herein lies the problem.  Experienced injectors know how to spread the injections and neuromodulator out across the forehead to prevent the bothersome horizontal forehead wrinkles in the center of the forehead, but still maintain enough muscle activity laterally to enable brow elevation.  Inexperienced injectors may frequently over treat a patient with upper lid skin excess and this leads to a very unhappy patient.  Due to the fact that some patients are more sensitive or more resistant to Botox or Dysport, a normal dose on one patient may knock out all forehead movement on another patient.  So….even experienced injectors occasionally may see upper eyelid skin excess from conservative treatment.  When injecting a patient who has never had Botox treatment or has never been treated by me, I always recommend 1/2 the normal dose in the forehead.  This allows me to evaluate the patients sensitivity and response to the treatment.  If the 1/2 dose is not adequate, they can always return for a touch up, but if the 1/2 dose is adequate then the full dose may have caused over treatment.  You can always add more Botox, but you cannot reverse it.  Good rule to practice by!  This is even more important in patients that have low hair lines or short foreheads and are having the glabella and frontalis simultaneously treated.  In these patients, the glabellar dose can be enough to effect the frontalis movement and it is easier to over treat this population.

Although this “relative skin excess phenomenon” is temporary, these patients can be more unhappy that a patient with a permanent surgical complication.  This group can be disproportionately unhappy about a temporary problem.  The best treatment is prevention and conservative injecting.  Sometimes these patients will mistakenly confuse the inability to elevate the brow and related skin excess with true ptosis.  True ptosis after neuromodulator injection occurs when the toxin diffuse to the muscles that open the upper lid, which is fortunately a very rare problem.  Injecting at least 10 mm above the superior orbital rim will prevent this complication.  A related problem is the “Mr. Spock” eyebrow.  This devil brow situation occurs when the medial brow does not move but the lateral brow is untreated.  This is a very unesthetic look and is easily fixed by simply injecting several units of drug into the lateral frontalis region.

Due to overtreatment, the desire to look natural and the “Botox upper lid skin excess” problem, the frontalis region has dropped from the second most requested facial area to the third.  The most commonly requested facial regions in my practice are the glabella (still king) the lateral canthus (Crow’s Feet) regions and finally the frontalis.

Another phenomenon that I more commonly see is “patient customization” of neuromodulators.  I am an Allergan Diamond level Botox provider and the largest solo injector in my state, so I have been treating some patients for over 12 years.  As time has passed, many of these patients request “a la carte” Botox treatment.  By this I mean that they desire smaller doses and come to the office with a “map” of their face and where they want the injections.  At first I thought that this was related to the economic recession and to some circumstance it may be.  What has become clear is that many patients don’t want to look over treated and like what Botox or Dysport does, they just don’t want as much of it.  Alternately, many astute patients have learned by trial and error, what doses and patterns produce the most aesthetic effects on their face.  They want do duplicate this injection dose and pattern and therefore it is important for the surgeon to record the area and dosages of the injections at each appointment.  This way, when a patient returns and says, “do exactly what you did last time”, the surgeon has a map.

Some of my colleagues become miffed when patients attempt to direct their treatment, but I think it is overwhelmingly a positive thing.  We are giving the patient what they want and the customer is always right.  In addition, they may save some money, making them even happier.

To find out more about Botox or Dysport by Dr. Joe Niamtu, III DMD in Richmond, Virginia visit www.lovethatface.com

Joe Niamtu, III DMD

March 23, 2010 Posted by | Botox, Dysport | , | Leave a comment

Dysport Units and Dilution Versus Botox Units and Dilution: 3 to 1 will get it done.

 

 

As neurotoxin science continues to advance and more drugs become available, patients will be offered more choices of treatments.  Currently Botox (Allergan) and Dysport (Medicis) are the only FDA approved neurotoxins (also called neuromodulators) to treat facial lines and wrinkles.  Numerous other similar drugs are currently in the pipeline for FDA approval, including products from China and Germany.  Patients outside the USA have more options and US patients will soon have some of these options.  More options are not necessarily better options as Botox and Dysport have long track records of safety and efficacy, but these new products will more than likely also offer safety and effectiveness and may also be more cost effective for patients.

All neurotoxins will be compared to Botox in terms of safety, efficacy, time of onset and duration of the effects.  As with any new product competitor on the market, positive and negative rumors will abound that can assist or detract from the new product.  Finally, all new products will settle in to their niche based solely on their effect and not conjecture.

Dysport has big shoes to fill in taking on Allergan’s previous monopoly of Botox.  Dysport has an excellent track record in Europe where it has been an option for a decade.  Like any new drug, doctors must figure out “the right way to use it”.  More than ever before, drug companies are strapped in getting the word out by Big Pharma regulations.  Although regulation is necessary, drug companies are literally hamstrung and sometimes voiceless.  Dysport would love to tell doctors the “best way” to use the new drug, but simply are not allowed, so it rests in rumor and conjecture as the means of determining “best practices”.

The biggest question of doctors new to Dysport is “how does the Dysport dosage relate to Botox dosage.  Being a consultant for both companies, I am asked this question frequently in my teaching travels around the US.  Initially, doctors were saying that “one Botox unit should equal 2.5 Dysport units”.  Although not an official comparison, this suggested that in order to have an equal effect, a patient that would normally have 20 units of Botox to treat their frown lines would require 50 units of Dysport to appreciate the same effect.  Comparison of units are not “apples to apples” official pharmicopia, but rather convenient conversions to anecdotally arrive at a standard between the two drugs.  Unfortunately, I believe that this first round of “units to units” comparison gave Dysport the short end of the stick.  Here is the reason.  When a new drug is introduced that competes with a standing giant, patients will try it (or not try it) based on numerous factors.  These selection factors include the advice of the treating doctor, cost factors, rumored advantages, the “newness” factor and the possibility that the new drug will simply work different or better.  Herein lies the catch.  If a patient has been getting successful Botox treatments with 20 units to their frown lines and wants to try the new Dysport and their doctor gives the rumored 2.5:1 ratio (50 units of Dysport), the patient is going to be a hard line test of which one works best.  In my experience, the 2.5 conversion is not enough Dysport to produce the effect of 20 Botox units.  If so, the patient will have a less profound or shorter acting effect and Dysport will be “dissed”.  My experience (and that of other surgeons) of using 3 Dysport units for 1 Botox unit seems to be a more accurate dosage in the quest for equipotent treatment between the two drugs.  If doctors are truly interested comparing these two drugs, they must use an equipotent dosage, which I believe to be 3 Dysport units for each Botox units or 60 units of Dysport for an area usually treated with 20 units of Botox.  Failure to use this ratio may give patients a false comparison of the effects and longevity of Dysport. 

Why is all of this important?  Personally, I feel that Allergan and Medicis are both great companies and I use fillers and neurotoxins from both of them.  From a doctor standpoint, you have to offer all contemporary options to your patients and from a consumer standpoint, every Coke needs a Pepsi.  What is important is that when comparing on new product to another, it is done in a fair way for the surgeon and patient to accurately evaluate.  Having said this, I believe the fair and balanced (hey, does that sound familiar?) way to this is to inject 3 Dysport units for where you would use 1 Botox unit.  Then the surgeon and patient can fairly evaluate the drugs.  It is unfair for the company and patients to compare with a lesser amount.  You will never find an official chart that says use 3:1 and Medicis is not allowed to even think that out loud, so it is up to the experience of scientifically minded clinicians to fairly sort this out for everyone else.  I am trying to do my part and I think it is 3:1 ad nauseum. To prepare Dysport for this dilution, 3 cc of preserved saline is added to the 300 unit Dysport vial.  Five  syringes are drawn up and each will contain 0.6 cc or 60 units.

To find out more about Botox, Dysport and cosmetic facial surgery in Richmond, Virginia visit www.lovethatface.com

Joe Niamtu, III DMD

Cosmetic Facial Surgery

Richmond, Virginia

http://www.lovethatface.com

November 22, 2009 Posted by | Botox, Dysport, Minimally Invasive Cosmetic Facial Surgery, New Cosmetic Surgery Technology | , , , | Leave a comment

Botox without Needles?

topical

For over 100 years, doctors have been administering medications with needles.  I can’t think of any single factor that patients of all ages hate about seeing the doctor that is worse than the fear of needles.  Besides scaring patients, many health care workers are injured or infected from accidental needle sticks.  There is nothing fun about needles!

There are hundreds of scientists and researchers constantly working on alternate medication delivery systems to get medications in the body without using needles.  We have made good progress with numerous medications.  Patients with chronic pain are able to get pain medication from patches applied to the skin and numerous other medications can be administered in this manner.  I predict that in the future, we will even be able to provide general anesthesia without needles or tubes in ones throat.

A topical, non injectable form of Botox (botulinum toxin A) is impressing researchers and is in phase II clinical trials. Revance Therapeutics is a private company in Mountain View, California that has developed a gel that is mixed with the Botox or Dysport that allows large macromolecules to cross the skin and provide local and targeted treatment of the muscle that causes “crow’s feet” wrinkles.  The company calls this technology TransMTS (macromolecule transport technology) and this technology is based on a single, straight-chain peptide that allows the skin to accept the medication instead of preventing absorption.  To get a bit more technical, adding a peptide as a separate component to the neurotoxin allows the medication to cross the skin. The peptide is said to form an ionic bond with the toxin and the peptide also has a protein transduction domain (PTD) which allows the medication to penetrate the skin.  The protein carrier featuring (PTD) holds on to the cell membrane and allows larger molecules to pass.   Currently, there have been over 600 crow’s feet regions treated with this technology with impressive clinical results and without complications.  Studies are also in place to use this topical application to the under arms for control of sweating.

No mention has been made of how long the treatment takes or how long it lasts and there will certainly be variables that effect results in given patients.  In any event this new technology is very exciting and representative of what the future holds for painless application of medicines.  This would be a very welcome addition in the cosmetic facial surgery arena.

To find out more about Dr. Niamtu and cosmetic facial surgery in Richmond, Virginia visit www.lovethatface.com

 

Joe Niamtu, III DMD

Cosmetic Facial Surgery

http://www.lovethatface.com

August 27, 2009 Posted by | Botox, Dysport, New Cosmetic Surgery Technology | Leave a comment

Dysport: the new “Botox”

relox

If Allergan’s Botox is Goliath, then Medicis and their new neurotoxin is David.  No one can argue that Botox has enjoyed a monopoly in the United States for past 15 years.  After all, Botox was a true paradigm shift in cosmetic surgery.  Never before, without surgery, could a patient have wrinkles disappear.  The introduction of Botox was something so different and so easy that it truly heralded in a new era known as minimally invasive surgery.  What began as a “pretty poison” has grown into “cosmetic maintenance” and now women and men get regular Botox injections with the same regularity that they get their hair colored or teeth cleaned.  Botox has not only continued to be safe and effective, but has gone on to treat many conditions from headaches to hemorrhoids.

Botox has gone largely unchallenged and Allergan has become a corporate giant due to its sales.  Second to Viagra it is the largest selling drug.  A brief challenge came in the “at the turn of the last century” with Myoblock, a similar product but chemically different.  Unfortunately for Myoblock, it did not live up to the effectiveness of Botox, and its popularity was short lived.  It is still used for the few patients that have a resistance to Botox, but is a small player.

Dysport is chemically very similar to Botox and has been used in the United Kingdom for 15 years.  It varies from Botox in its biochemistry and protein structure but basically does the exact same thing.  This drug has recently received FDA acceptance and will be sold in the United States under the same name.  Dysport will make a big bang with the media upon it final FDA acceptance and rumors will fly.  The Dysport FDA trials showed that Dysport took effect somewhat faster than Botox and basically lasted the same amount of time, about three months.  Why challenge the king of neurotoxins (more politically correctly called neuromodulators) with a drug that basically does the same thing.  I call it Coke versus Pepsi marketing.  Consumers and surgeons desire choices in everything from clothes, to cars to, carpet and want choices.  There is also some bragging rights from being the “new kid on the block” (just ask Red Bull).  Cosmetic consumers and media are fascinated by “new” technology and if it is new then it must be better.  Frequently this does not pan out, but a well marketed and effective competitor can certainly gain market share.  When all the US automakers were getting bailed out by the Federal government, Toyota (who was a newcomer to this country) remained strong.

To cut to the chase, Dysport is exciting because it is new and is also taking on heavyweight Botox.  It is likely to become a popular competitor.  What remains to be seen, and could make the difference in the wrinkle wars, is how Dysport is priced in comparison with Botox.  If Medicis significantly undercuts Allergan, Dysport could potentially displace the king.  I doubt that this will happen as corporate America is not fond of less profit.  A similar scenario occurred with Restylane, the revolutionary lip and wrinkle filler from Medicis.  This was the first new filler that was FDA approved and made a meteoric rise to the top of facial injectables.  There was no significant competition for about 4 -5 years until Allergan obtained FDA approval for Juvederm.  In the pre release period, much speculation occurred as to whether Allergan would significantly undercut the pricing of Restylane.  Guess what?  They did not.  Their pricing was almost identical and Juvederm no doubt took a chunk out of the filler sales dominated by Allergan.  Competition is generally a good thing as it offers the public more choices and can sometimes drive down prices, but don’t look for this with aesthetic companies.  They figure if patients will spend $500 for X, then they will spend it for Y.  Time will tell.

To find out more about Botox, Dysport and other cosmetic facial surgery procedures, visit www.lovethatface.com.

 

Joe Niamtu, III DMD

Cosmetic Facial Surgery

Richmond, Virginia

www.lovethatface.com

January 14, 2009 Posted by | Botox, Dysport, Minimally Invasive Cosmetic Facial Surgery, New Cosmetic Surgery Technology | , , , | Leave a comment

Is Botox Safe?

Recently the news media has been blitzed with warnings about Botox treatments resulting in patient deaths.  Obviously, this is a very serious matter, but it also begs some investigation into the facts of the matter.

Botox is the trade name for botulinum toxin A.  This is a protein derivative obtained from bacteria.  In the concentrated state this is a dangerous toxin but in the extremely dilute state it has been used safely and effectively for almost 40 years.  A similar analogy would be Tylenol.  If you have a headache and you take two Tylenol, you will not experience problems, but if you were to take 10 or 20 of the same Tylenol tablets you could experience a fatal outcome.  The same can be said about salt and water.  Salt on your French fries is harmless but if you were to ingest a cup of salt the outcome would be serious.  Although water is a necessity of life, each year we read of deaths from water intoxication, usually related to fraternity stunts and the like. The bottom line is that you can take almost any safe substance and if you take many times the recommended amount, it can kill you.

As to the Botox news, there are several facts that are important to know.  First of all, there are several preparations of botulinum toxin A, some which are not approved by the FDA for use in this country.  The reports of death may not have been Botox at all, but one of the other preparations.  This was not mentioned.  Furthermore, and most important, is the fact that the deaths in question were children with cerebral palsy that received extremely large doses in the neck area.  The average dose for Botox, used cosmetically in the face is 25 units, some of these children received hundreds of units.  In addition, these large doses in the neck area are more dangerous than the very small doses in the upper face.

I have two children with severe cerebral palsy and they have safely received Botox treatments for their spasticity.  In addition, I myself, use Botox and have also used Botox on my wife and staff for the past 12 years.  I obviously would not subject myself or loved ones to any medication that I thought was unsafe.

I do feel that it is important to have Botox or any similar medication administered by a trained professional that is familiar with the medication as well as the complex anatomy of the head and neck.  Although some doctors choose to have their staff administer Botox, I always personally perform all injections.  I am a Platinum Plus Botox provider.  This means that I use over 550 vials of Botox per year.  I am the biggest user of cosmetic Botox by any doctor of any specialty in my city and a 100 mile radius.  I don’t bring this up to brag, but rather to illustrate my experience, confidence and safety record with Botox.  In addition I am a certified Botox trainer and have trained doctors from all specialties from all over the world.  I am also a consultant for the Botox National Education Faculty which consists of selected specialists that are the biggest users of Botox nationally.  This group sets the standards of Botox treatment.  Of the tens of thousands of Botox injections that I have performed over the past 11 years, I have never seen a single serious health problem related to the medication.  To me, that is an excellent safety record.

The following is an official statement on this situation from Allergan Inc., makers of Botox Cosmetic.

·         As you know, the FDA recently issued an “Early Communication” reviewing certain serious adverse events following the use of botulinum toxins.  The FDA inquiry relates primarily to high dose medical uses of Botox, particularly for the management of juvenile cerebral palsy, rather than the use of Botox for cosmetic purposes.  [In the event the reporter has covered the story already: Given that you have covered the topic in the past, I wanted to share with you additional information on the matter in the event it is helpful as you develop follow up stories.]   ·         As many patients are not aware, Botox is indicated and used worldwide to treat a variety of often serious medical conditions, while Botox is also approved in certain countries, including the US, for the aesthetic treatment of wrinkles between the brows which involves very different doses. The dosing received by a healthy adult patient who receives Botox for aesthetic use generally ranges between 20U and 50U vs. a child treated with Botox for juvenile cerebral palsy, who may receive between a total units of 100U or 700U.     ·         In the physician community, we know that over a million people have been treated with Botox for cosmetic use.  In its entire history, there has never been a single reported death where a causal link to Botox Cosmetic was established.  Regarding any serious adverse events reported following the use of Botox therapeutic, it is important to note that in its more than 18-year history since the product was first approved worldwide, reports of serious adverse events following Botox have been rare. ·         The posting of an “Early Communication” by the FDA on February 8 is merely a routine protocol used by the Agency to provide early information regarding safety or other related reviews, often before any conclusions are or can be made.  Specifically, the FDA made clear in its communication that “the posting of this information does not mean that there is a causal relationship between the products and the adverse events.” ·         Importantly, the FDA hosted a public teleconference last week in which it provided helpful clarification and context, explaining that this review involves only “a relative handful of serious adverse events” and that the primary focus of the adverse events and the FDA’s review of them related to the therapeutic use of Botox to treat juvenile cerebral palsy and other large muscle, lower limb spasticities.   ·         While Botox is approved in about 60 countries to treat juvenile cerebral palsy, it is not approved for this use in the United States. Fortunately, the FDA’s Rusty Katz in the media teleconference was clear to point out that this review involves a small number of adverse event reports involving large doses in a very sick population and should not be interpreted as a suggestion that Botox is not an appropriate treatment for juvenile cerebral palsy.   ·         The treatment of juvenile cerebral palsy involves very compromised, sick children and it also involves relatively large doses of product (often up to a total of 700 units).  In some of these adverse event reports, the physician had used doses that were much higher than the approved label for juvenile cerebral palsy in those countries that have approved its use; by way of comparison, some of these adverse event reports indicated doses of greater than 80 times that of a typical aesthetic use on a per kilogram of body weight basis.     ·         As the FDA’s own press release on the topic notes, these adverse event reports do not indicate any problem with a batch of Botox but rather may relate to overdosing by the physician.  The manufacturer’s analysis indicates that when a problem arises in the use of the product for juvenile cerebral palsy, it tends to either be because the patient was already very high risk and sick and/or because a significant amount of Botox was administered.   ·         While not approved in the United States, physicians specialized in neurological and neuromuscular disorders have been using Botox for the treatment of juvenile cerebral palsy /spasticity with great success for more than a decade at their own medical discretion; and most physicians who use Botox in this way are well aware of the risk/benefit profile in this population and use it after making an informed medical judgment that the treatment is appropriate. ·         Furthermore, we physicians are aware that the product labeling for Botox already notes rare select cases of fatal outcomes in which some patients had significant debilitating conditions or may have had a history of cardiovascular disease or other co-morbid conditions. And the Botox labels specifically warn that patients with pre-existing neuromuscular disorders may be at increased risk of clinically significant systemic effects from typical doses of Botox.  The discussion between the manufacturer and the FDA is merely about whether further clarify is needed about the definition of juvenile cerebral palsy as a “neuromuscular” disorder. ·         Finally, it is equally as important to understand that a report of an adverse event following treatment with a drug does not by itself mean that the drug caused the event, just that the event occurred after treatment with the drug.  So, for instance, if the manufacturer of any drug is notified of an adverse event following the drug from any source, it is required to make an “adverse event report” to the appropriate health authorities even if the manufacturer or the physician has not established that the drug caused the event and, indeed, even if the treating physician has affirmatively concluded that the drug was not the cause of the event. 

March 17, 2008 Posted by | Botox | , , , | 1 Comment