FDA Issues Strictest Warning Label on BOTOX

After Consumer Groups Petitioned the FDA for Investigation on BOTOX citing it can kill.

"The toxin can cause muscle weakness and breathing difficulty, particularly in non-approved applications for muscle spasms.."
- Harry Kimball, Newser

FDA (Food and Drug Administration) study regarding botulinium toxin safety
On April 30, 2009, the FDAissued it strictest warning label on Botox, Botox Cosmetic and Myobloc after it initiated an investigation in February 2008. As part of the warning the FDA now requires a "Black Box" warning regarding the risk that the effects of the "toxin can spread beyond the injection site" by the manufacturers of licensed botulinum toxin products.

Botox Links:

* Birth Defects
* Respiratory Failure
* Death
* Difficulty Swallowing
* Muscular Weakness
* Speech Disorder
* Facial Drooping
* Double Vision
* Drooping Eyelids

Who initiated the investigation?
This investigation was prompted by the non-profit consumer advocacy group, Public Citizenin January 2008 when they petitioned the FDA to add a Botox FDA Warning on the products' labels because of serious adverse reactions. Public Citizen cited over 180 cases (information that came from FDA data) of U.S. patients suffering from many serious side effects including fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths. Four of the 16 deaths were children under the age of 18. Public Citizen also cited 685 cases of serious adverse effects from 1997-2006. "The FDA data come from voluntary reports, which have been estimated to account for only 10 percent of actual cases." (Public Citizen January 2008)

As a result of this petition the FDA launched an investigation in February 2008.

Botox Problems

Our Statement of Opinion
We, at MedSpa New England, have questioned the safety of such a poison for the rampant use in this country. As a society, we have become numb to the many uses of Botox and have developed a perception that Botox is just as easy and safe as waxing without considering the serious side effects of this product. Many even have "Botox Parties" out of their home. As consumers, we should be more concerned that it took a consumer advocacy group to pressure the FDA to do this investigation.

So we find it interesting that the FDA now issues this warning for exactly what many people don't think could happen to them when receiving Botox. We questioned many times whether or not to offer Botox through MedSpa New England. Every time, we decided against it. Many reasons include a huge increase in liability and malpractice insurance, costs, and side effects. Our goal is to find alternatives to plastics and poisons that are safer. This is why we offer many Botox alternatives that are safer and less invasive to your body including Kinerase, Kinerase Pro+, and PPx Therapy.

If you are considering having Botox, please consult with your doctor to ensure Botox is right for you.

Other FDA Requirements:
In addition to the Botox FDA Warning, the FDA is "requiring" that Botox manufacturers develop and implement a Risk Evaluation and Mitigation Strategy (REMS). These requirements include the drug makers to distribute a Medication Guide alerting patients of the potential risks, and to submit safety records. The irony is that many physicians have not been given the proper information in the past to pass on to their patients or they do not address the potential side effects of Botox so the consumer can make an educated decision.

Does this affect all Botox Brands? Yes

botox

Another Botox Consumer Alert: Something consumers do not take into consideration. In December 2008, Australian authorities reported that Dysport, an anti-aging wrinkle treatment, was administered during pregnancy to a child who was born deaf and blind. Although Dysport is not available in the United States, it contains botulinum toxin Type A, the same active ingredient in Botox and Botox Cosmetic. Because new information is issued all the time, we will not use our PPx system (laser) on those women who are pregnant, trying to get pregnant, or breast feeding. This is not worth the risk to you are your child.

Industry Facts
- 2007 Botox becomes #1 cosmetic procedure
- 2007 Botox sales exceeded $1.2 Billion
- Only FDA approved cosmetic procedure - Vertical Furrows between eyebrows
- After injection, maximum effect takes 48-72hrs
- Duration of effectiveness - 6wks to 8months

Any Other Side Effects?
Many other side effects are considered by the FDA minimal, temporary and reversible.
They include:

* Soreness or mild bruising around the injection site.
* A temporary headache after injections in the forehead area, especially after the first treatment.
* In rare instances, weakness of the neighboring muscles leading to a temporary droopy brow or eyelid.

*Underlying the different uses of Botox is the important fact that it is "extremely poisonous and long lasting," according to Dr. Daniel Drachman, a neurologist at The Johns Hopkins University, who has been studying botulinum toxin for the past five decades. The toxin can remain active in the body for up to several months. While these properties make the drug effective at low doses, he cautions that, "especially with rather large doses, you've got to be very careful." (*Scienceline, by: Carina Stors)

Latest FDA Alert on Botox: August 11, 2009
"ALBANY PLASTIC SURGERY GROUP PLEADS GUILTY IN CONNECTION WITH USE OF UNLICENSED "BOTOX" SUBSTITUTE ON UNSUSPECTING PATIENTS"

If you are considering having Botox, please consult with your doctor to ensure Botox is right for you. As always do your research.

Your feedback on this information is greatly appreciated. Please let us know if you found this helpful.

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© 2009 Laura Bonetzky-Joseph, MedSpa New England, LLC.
This information is for general educational uses only. It may not apply to you and your specific medical needs. This information should not be used in place of a visit, call, consultation with or the advice of your physician or health care professional. Communicate promptly with your physician or other health care professional with any health-related questions or concerns. This article does not share the opinions of MedSpa New England, LLC. Be sure to follow specific instructions given to you by your physician or health care professional.