Dear Paula,

I have read an article at an online news site about the new health hazards associated with Botox injections. It seems there’s a group that has petitioned the FDA about including stronger warnings on Botox because people have died from it. This is scary stuff—am I risking my health, or worse, my life, simply by getting some tiny injections to smooth my expression lines?

Samantha, via email

Dear Samantha,

As someone who has been getting routine Botox injections for the past several years, the latest news on Botox initially had me concerned, too—until I did some investigating that helped clarify the issue and put things into context. Before I go into details, let’s discuss the subject of risk. When it comes to cosmetic corrective procedures such as Botox, which is by far the most popular (millions of injections are done every year) it has also been used for over 40 years to treat side effects of cerebral palsy, eye tics, or dystonia. Whether Botox is used to eliminate (and I do mean eliminate) wrinkles on the forehead or treat serious medical conditions there is always some amount of risk involved. That’s why it is critical to do your homework before having any procedure, however minor, performed. As the patient, you must ensure the pros and cons of each procedure is discussed in detail with the physician doing the work—and you must be certain the physician you’re speaking to is well-versed on the topic and has significant experience with the procedure. Only when you’ve done your own research and looked beyond hype and hysteria in headlines or on some random web site, can you make an informed decision about whether or not to go ahead with whatever procedure you had in mind.

For the record, the most common side effects from Botox injections include temporary eyelid droop, nausea, headache, dizziness, and bruising or redness at the site of injection (Source: www.drugs.com). All of these side effects are temporary, with most disappearing in a matter of days or, in some instances, after the effect of Botox has worn off, which usually happens 4-6 months after the procedure.

The current controversy surrounding Botox Cosmetic is its link to nearly 200 patients experiencing “serious complications” and a total of 16 reported deaths in the past ten years. As a result, a group known as Public Citizen sent a petition to the FDA asking for stronger warnings on both Botox and another drug known as Myobloc (botulinum toxin type B, which isn’t used for wrinkles at nearly the same rate as Botox). The FDA’s response was that it feels the warnings already included in product information for Botox address these concerns, but may consider adding additional warnings for off-label use (meaning the use of Botox for something it was not approved to treat).

Dermatologist Dr. Leslie Baumann wrote an excellent article on this topic, and I’d like to present highlights of it here, since her piece was well-written and objective:

• All the safety concerns Public Citizen raised 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.
  
• While Botox 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.)
  
• 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.
  
• Botox is safe for cosmetic use when used by experienced doctors. If you are interested in trying Botox treatments for cosmetic purposes, ensure that they are performed as safely as possibly by ensuring the following: Always get your Botox injections from a dermatologist, plastic surgeon, facial plastic surgeon, or oculoplastic surgeon; Make sure your doctor is board-certified. To find a board-certified dermatologist in your area, visit www.aad.org; Ask your doctor how many patients he or she has treated with Botox. If the number is under one hundred, go to someone else.

So what can be surmised from the vast amount of information on Botox and Dr. Baumann’s assessment of this scare is that it is still an overwhelmingly safe cosmetic corrective procedure to have, provided you take care to choose an experienced medical professional to administer the injections and you’re aware of the potential side effects, from the most common to the statistically very small but still possible risks. Additional sources include: Seminars in Cutaneous Medicine and Surgery, March 2007, pages 29-33; Dermatologic Surgery, January 2007, pages S18-S25 ; Archives of Dermatology, March 2006, pages 320-326; and Journal of the American Academy of Dermatology, December 2005, pages 1,080-1,082).