Is Botox Dangerous?
You may have noticed some alarming headlines about Botox yesterday, when a U.S. consumer group called Public Citizen released a petition asking the FDA for stronger warnings for Botox and Myobloc, the two forms of botulinum toxin currently approved in the United States. (Myobloc, though not a household name like Botox, is approved for the treatment of neck spasms; some doctors may also use it to treat facial wrinkles.) But before you write Botox off, take note: All the safety concerns Public Citizen raises are already addressed in the drug’s labeling. Furthermore, it is important to put the 180 serious complications and 16 deaths reported over a decade — which may have resulted from the drugs spreading past the injection site to other parts of the body — in the context of the many millions of times Botox and Myobloc have been used.
Public Citizen has three primary requests: 1) that the warnings on the drugs’ current labels be upgraded to “black box” warnings, making them more prominent; 2) that the companies that produce these drugs be required to issue a letter to physicians, detailing potential risks and how to recognize signs that the drugs are spreading to other parts of the body; and 3) that patients also be issued a guide explaining the drugs’ risks whenever they are used. These regulations would be similar to those already in place in the E.U.
First, let me clarify an important point about Botox: While it is most commonly known as a wrinkle treatment, it also has many important medical uses. In fact, medical and cosmetic Botox are sold in different packages. Anyone scanning the headlines over the past couple of days might think that patients who seek to smooth wrinkles are putting themselves in harm’s way. In fact, Public Citizen cites 16 potential Botox- or Myobloc-related deaths reported to the FDA from 11/1/97-12/31/06, of which only one may have resulted from cosmetic Botox treatments. (I say “may” because none of these complications can be conclusively linked to botulinum toxin.) One death is certainly one too many. But I can affirm that in my years of practice, I have never seen or heard of a serious complication resulting from cosmetic Botox treatments; the most common side effects are mild bruising or eyelid drooping, both of which are temporary.
So why might medical Botox injections come with more complications than cosmetic Botox injections? First of all, the dose used for medical treatments is typically far higher than the typical cosmetic dose. It’s also important to note that non-cosmetic indications for Botox include several serious health conditions. Four of the 16 reported deaths, for example, were children. And while I don’t know the specifics of the cases in question, I do know that children treated with Botox injections often suffer from cerebral palsy, which can bring with it multiple medical complications. While those deaths are tragic, it is also important to note that Botox and Myobloc can greatly enhance the quality of life of patients who suffer from cerebral palsy and other muscular disorders.
In their official statement, Allergan, the company that makes Botox, noted that “Allergan is in frequent dialog with the FDA to ensure proper labeling for its products and also submits information on all adverse events that are received whether or not they are considered related to the drug. In collaboration with the FDA and other regulatory agencies around the world, Allergan regularly reviews safety information and updates the labels for its products as appropriate.”
In my opinion, there is no need to change the labeling of cosmetic Botox, although there is certainly no harm in calling further attention to warnings that already exist. No change is being proposed to the approved uses or distribution of the drug itself, for which I am glad — while Botox can be an anti-wrinkle wonder, it can have an even more important impact on the lives of those who suffer from various muscular disorders.
Bottom line: Botox is safe for cosmetic use when used by experienced doctors. If you are interested in trying Botox treatments for cosmetic purposes, ensure that the they are performed as safely as possibly by following a few important steps:
1. Always get your Botox injections from a dermatologist, plastic surgeon, facial plastic surgeon, or oculoplastic surgeon.
2. Make sure your doctor is board-certified. To find a board-certified dermatologist in your area, visit www.aad.org.
3. Ask your doctor how many patients he or she has treated with Botox. If the number is under one hundred, go to someone else.
These products have been used for over 17 years worldwide and I have never heard of a complication after cosmetic treatment by an experienced doctor. Several other forms of botulinum toxin are expected to be approved in the near future. While I absolutely agree that patients should have as much information at their disposal as possible, I also expect these drugs to continue to be used with great success.
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