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 26

Botox and Safety

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Botox has an excellent record of safety and efficacy. Although FDA clearance happened within the last ten years, Botox has been used off-label for cosmetic purposes since the mid 1990's. 

There are certainly instructions one must follow and contraindications. Just be sure you are getting the gold standard. Botox. To be sure, visit the Botox Cosmetic website to be certain your plastic surgeon or dermatologist is among the top providers of Botox in your region. And remember, the product is only as good as the provider. Fine someone experienced, with a conservative hand.  Take a look at your nurse injector and see if their results seem natural. Start with a consultation. There should be a no cost, no pressure consultation. Start with a consultation only and get a feel for the practice and injector before you have your first treatment. 

Raleigh-Durham Plastic Surgeon
4.8 out of 5 stars 123 reviews

Botox safety and warnings of complications

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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.

Peter A. Aldea, MD
Memphis Plastic Surgeon

Botox safety

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Botox (direct from the manufacturer, Allergan) has a long track record of safety, when used appropriately for cosmetic purposes. There are, of course potential complications for any cosmetic treatment you could undergo, and Botox is among the safest.

Good luck.

Bryan K. Chen, MD
San Diego Dermatologist

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Botulinum toxin safety

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Botulinum toxin was first isolated in the 20s, was first used therapeutically in 1968, and became approved in 1989 for eye issues. It has been used heavily for cosmetic use since 2002, and it was the first aesthetic drug ever approved.  All that is to has a lot of safety data behind it. Recent evidence (coming out this week) proves that botulinum toxin does NOT enter your brain as it's distant cousin tetanus toxin does, which is where that theory came from. 

Botox, Dysport and Xeomin are the 3 botulinum toxins approved for cosmetic use in the US. They all work in the same way, at the presynaptic terminal blocking the release of acetylcholine - making the nerve temporarily unable to communicate with the muscle. It is broken down as a protein in our body with liver metabolism. Effects are temporary, and repeated use serves to take tension off of your skin, relaxing lines and wrinkles.

To ensure you are receiving the highest level of care, seek out a modernly trained, new-school dermatologic surgeon, oculoplastic surgeon, facial plastic surgeon or plastic surgeon who is board certified and fellowship trained in one of these "core four" cosmetic specialties. Membership in organizations like the American Academy of Facial Plastic and Reconstructive Surgery help to identify a highly trained surgeon.

Cameron Chesnut

#realself500 Physician

Botox Is Safe

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I have been injecting Botox for close to 20 years.  I have NEVER seen a serious reaction to it in my practice.

The Botox doses that we use for cosmetic treatment are very low and would be extremely unlikely to cause a systemic problem.  There have been many millions of people injected with Botox and, to my knowledge, there has never been a death caused by Botox cosmetic treatment.

I have injected my closest family members and myself with Botox without any concern.  I would never put my family at risk if I thought there was the potential for any problems. 

People are sometimes scared to try Botox because they've heard or read something negative about it (most of which is unfounded).  Once they try it and love it, they are amazed that they had any concerns in the first place. 

Once in a while I see a patient who says that they would never do Botox and that's the right choice for them, but the tradeoff is that they have to live with their wrinkles.  My thinking is that if you can do something to improve wrinkles that's non-invasive, safe, and effective, why not?

Safety of Botox. Spread Issue

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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.

Botox is actually safer than Aspirin

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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.

Botox Safety

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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
4.4 out of 5 stars 7 reviews

Botox side effects

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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

Botox is a medical treatment

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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
4.9 out of 5 stars 38 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.