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.
Laura Bonetzky-Joseph, Managing Director and Holistic Practitioner at MedSpa New England, LLC located in Hingham, Ma.
Laura believes that no matter what you are seeking, balance is key - mind, body or spirit. If any of those three areas are out of balance, your whole system will be out of balance. She has found this to be true in all aspects of the services provided at MedSpa New England. She strives to provide the very best services, classes, workshops, & events. Laura also customizes services to meet her client’s individual needs.
Fortunately, Laura was raised in a medical family where she learned hands on about various alternative holistic therapies & general health for the past 20 years. Laura's father has been a holistic osteopathic physician and surgeon with a focus on general health, wellness & dermatology for over 30+ years servicing the south shore, who is currently the medical director overseeing MedSpa New England, LLC.
Laura’s mother is a retired registered nurse and a nurse administrator with 20+ yrs experience. All of Laura’s life has been engulfed in the field of health & wellness. She assisted in the office management of her father’s medical practice since the age of 18 and over the coarse of the past 20 years, she has learned about general health care, alternative holistic therapies, dermatology, challenges with the heath care system, assisting in office procedures, phlebotomy, EKG, administration, and more.
Laura is very compassionate and passionate about what she does. She is always studying and looking for ways to improve and better serve her clients, and works on implementing services that she or someone close to her has personally had a positive experience. Laura has studied under Rita Berkowitz, LeRoy Malouf, Rachelle Croteau, Mary D'Alba and Britain's own Brenda Lawrence and is always taking holistic, spiritual, & medical courses to better serve her clients. She is a certified medical assistant and an Usui Reiki Master Teacher & Practitioner and a facilitator for various workshops, groups, events & classes such as Meditation, Stress Reduction, Reiki, and Food Sensitivities. Laura is also certified in PPx Therapies, and practices alternative therapies to modern medicine working in conjunction with other medical professionals. Laura's goal is to attain her Nurse Practitioner's License within the next couple years.
She's the moderator for various online health & wellness groups including Myspace & LinkedIn & volunteers her time helping those healing from abuse.
Laura's mission is to find the best of both worlds in the traditional and holistic world. Having overcome health challenges herself as well as her family, Laura implements she has learned, studied, experienced and found to help her own family's health and wellness. Her goal is to have a positive impact in this world, make a difference in people's lives and find simple preventative cures for complex problems. Her desire to help others stems from her daughter born with a variety of health challenges including a food sensitivity to almost everything.
Fortunately, it was with Laura’s training and mother's instinct that pushed her forward and with help of family in the medical field, she discovered her daughter had a serious internal birth defect that required urgent surgery at the age of 3 months. The experience changed her family’s lives forever and led Laura to become interested in food sensitivities and what she calls "an under-diagnosed and unrecognized field heading towards epidemic levels due to all the chemically and genetically modified foods, over-processing, over-vaccinating, and the overuse of anti-bacterial soaps." (New England Business Bulletin; Pamela Berard; Nov 2010)
She has volunteered her time to Old Colony Hospice and has served as a past Fall Gala Committee Member in 2006-2007 raising nearly $10,000. She is also a past member of ADD-In, Local Chapter support group for ADD/ADHD & StepUp4Kids, support group for Bipolar, ADD/ADHD, Asbergers, & Autism.
Laura was recognized in 2009 & 2010 as one of the top professionals under the age of 40 by New England Business Bulletin. She was one of the featured recipients in the article “Sixteen honorees were selected for innovation, leadership, and community service;” by Pamela Berard, a New England Business Bulletin correspondent on November 24, 2010. She was also the 2008, 2009, 2010 recipient for the Healthy Living Award given by Healthy Living Magazine for her contributions to the health and wellness communities.
Laura has published articles on topics such as Vitamin D, Stress, and Meditation on sites such as SelfGrowth.com and Take5.com. You may view a sampling of her work on her website.
For more information on Laura or MedSpa New England, LLC, go to her website or call 781-422-2294.