Ask a doctor

How is Botox Safe if There Are Warnings About Complications?

I was checking out Botox Prescribing information and the first thing I read is a warning that Botox Cosmetics may spread from the area of injection and may cause, among others, difficulties breathing and swallowing that can be life threatening.

How can Botox be considered a safe procedure with this kind of warning?! Now I'm definitely scared.

Doctor Answers 23

Botox safety and warnings of complications

Dear Maya79,

A few questions:
- do you really need to be told NOT to use a hair dryer in a water filled tub or in the shower?
- Have you read the side of ANY ladder in your neighborhood Lowe's or Home Depot?
- How about the "instructions" on the use of ANY household appliance and every single medication?

The initial reaction is a smug feeling of superiority and a thought along the lines "...there must be a lot of morons out there that this is written for". Well, 304,059,724 American morons as of July 2008 and increasing. These morons are ruled and legislated to at last estimate by 1,143,358 lawyers (American Bar estimates by the end of 2007) - (compared with 301,270 doctors in the US).

Our society is ruled by and for lawyers. They have imprinted and taken over EVERY aspect of our lives.

After all - do you REALLY think someone dumb enough to operate a hair dryer in the shower, play with his dish on the roof during a thunder storm or lean a metal ladder near power cables would ACTUALLY take the time to read the instructions on the side? - of course not!

As regards the Botox scare - it was begun an organization supported by America's plaintiff bar, which are among its major supporters

Despite MILLIONS of treatments for cosmetic indications with Botox Cosmetic - there has NEVER been a reportable case of death with it. Can you name a SINGLE drug with such a safety record?

But No - to ensure a steady income to lawyers on both sides of the debate that group petitioned the FDA to put the equivalent of those ladder warnings in Botox boxes to scare the filling out of our patients.

But Plastic surgeons have seen the SAME group in action in 1991. At that time the FDA commissioner and his assisant (who was married to a plaintiff lawyer and member of the same group) put a moratorium on the use of silicone gel implants. Hundreds of thousands of lawsuit drove Dow, silicone gel producer, into bankruptcy. Of the more than 10 companies producing breast implants, only two survived and they more than tripled the costs of their implants. But- worse of all thousands of women neglected to have mastectomies because they did not want to be mutilated without a good breast reconstruction. Tens of thousands NEEDLESSLY had their implants taken out because plastic surgeons wanted to relieve them of the fear despite scientific proof that their implants were defective or injurious in any way - and plaintiff lawyers made BILLIONS!!!

As a result - to our eternal shame breast implants are the most intensely studied device IN HUMAN HISTORY. More than heart valves, artificial hearts, pacemakers, defibrillators, all joints - everything. There is NO WAY that a breast implant should over shadow an implantable cardiac assist device in the number of articles and research done to assure its safety - but it does.

All of this was caused by the same group of "activist" whose sole purpose, despite protestations otherwise, is to enrich the American lawyers at our collective cost.

This job - they have done extremely well.

As for Botox - I would have no problem giving it to my mother and wife. I have done both in the past.

I would NOT give it a second thought if I were you.

I hope this was helpful.

Memphis Plastic Surgeon
5.0 out of 5 stars 80 reviews

Safety of Botox. Spread Issue

Botox is a very safe drug. Millions have used the treatment. It is the most popular cosmetic treatment in the world. That being said, there are always risks, (albeit very small), of any treatment. The box warning that you refer to is the same for all drugs in that class.  It was originally applied to Botox's competitor Dysport.  Dysport then went to the FDA and convinced them to put it on all the drugs in this class. It is important to choose your injector wisely. Ask questions about training and experience. Have realistic expectations, and take the time to tell your injector what your goals are.

Jeffrey Roth, MD
Las Vegas Plastic Surgeon
4.5 out of 5 stars 11 reviews

Botox is actually safer than Aspirin

Botox is not recommended for any patients that have an allergy to Botox, a skin infection at the site of the injection, a muscle or nerve disease, breathing issues, swallowing issues, bleeding issues, an upcoming surgery, previous facial surgery, weak forehead muscles, drooping eyelids, or are pregnant or breast-feeding.

If you do not fall into any of those categories, and have made sure you are getting authentic Botox manufactured by Allergan and administered by a trained and well-experienced professional, it is safe. Botox has been used for almost 25 years on millions of patients in over 70 countries, and it's one of the most researched and carefully monitored medications in the world.  It is actually safer than many common medications such as aspirin, insulin, or Tylenol.

Steven Svehlak, MD
Los Angeles Plastic Surgeon
4.5 out of 5 stars 21 reviews

Botox Safety

Hi Maya,

Botox Cosmetic has the same warnings that accompany Botox for the non-cosmetic uses for Cerebral Palsy and other types of muscle spasms even though the amounts of Botox are dramatically different when used for cosmetic purposes.

Botox Cosmetic has a better safety record than aspirin. So, while we understand your concern after reading the warnings, if you read the warnings on other common medications, you would find that many have similar imposing warnings. If the risks seem too great then we would certainly advise you to avoid Botox, but Botox has an excellent safety record.

Harold J. Kaplan, MD
Los Angeles Facial Plastic Surgeon
5.0 out of 5 stars 6 reviews

Botox side effects

It is important to read and understand all the possible side effects from Botox injections. However, as with any medicine, the serious side effects, are uncommon. The typical side effects after injection that occur up to 5 % of the time include mild injection site bruising, ptosis, and occasional headaches. Botox has been used millions of times for many reasons and not for just cosmetic purposes and the reported incidence of serious side effects is extremely low .

Steven Hacker, MD
West Palm Beach Dermatologic Surgeon
5.0 out of 5 stars 4 reviews

Botox is a medical treatment

The side effects you mentioned are expressly described by the company for having been noted after Botox was used for neurologic uses such as muscle spasm. They continue to state that these side effects have not been noted with cosmetic use as indicated by the company. Neurologic use of Botox involves a much higher number of units than what is used for cosmetic purposes. It is important for all to be mindful that Botox is a medical treatment and with all treatments, there are risks. Discuss this with your physician.

Ronald Shelton, MD
Manhattan Dermatologic Surgeon
5.0 out of 5 stars 33 reviews

Is Botox Safe?

Yes! If used properly, like anything else. The only major complications have arisen using Botox off-label for unapproved uses, especially in high doses in children for neurologic diseases. The warnings are necessary for your own decision making and to discuss with your doctor. There are side effects, but following proper cosmetic use with proper technique and dosing, these should be temporary and reversible.

Michael Coverman, MD
Austin Dermatologist
5.0 out of 5 stars 1 review

Botox and Safety

My question is then do you read the insert on aspirin, tylenol and motrin. If you have then you would not be taking those either. There are always risks with everything that we do in our daily life, like crossing the street and driving a car. It all depends if the risks are realistic and common or not.

So......having said that, botox is relatively safe and given the amount that has been used across the country and world, we know it safety parameters.

You may still not desire to have this done, which is fine, but when ever you look at any surgery you as the patient need to look at the risks and benefits after a qualified board certified plastic surgeon has put it all into perspective for you.

Good luck.

Farbod Esmailian, MD
Orange County Plastic Surgeon
5.0 out of 5 stars 59 reviews

Risks of botulinum toxin

IF you are scared then don't do it. It is not for you and you may not be a risk taker. But if you read the side effects of aspirin  or ibuprofen, my guess is you would be scared and should not take them either. It is my opinion that botulinum toxin when administered properly is safer than aspirin.

Otto Joseph Placik, MD
Chicago Plastic Surgeon
5.0 out of 5 stars 56 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.