The Food and Drug Administration (FDA) is investigating rare reports of serious adverse events
linked with Botox, Botox Cosmetic and Myobloc.
If you have already received Botox injections
or are considering Botox injections for cosmetic reasons, here's what you need to know. The investigation is still in
its infancy; this Q&A will be updated as new information becomes available.
Why is the
FDA looking into the safety of Botox?
A Washington, D.C.-based consumer watchdog group called
Public Citizen reviewed FDA data and found that the agency had received reports of 180 U.S. cases of people developing sometimes
life-threatening conditions, including respiratory failure, after receiving Botox injections (botulinum Types A and B). Sixteen
deaths had occurred, four of which were of children less than 18 years old. Public Citizen then filed a petition with the
FDA calling for stronger and more widely disseminated warnings concerning these risks.
What
sanctions is Public Citizen calling for?
Pubic Citizen is asking for a "black box"
warning on Botox products. This is the strongest warning that the FDA can place on a product. The group also wants doctors
to inform patients receiving Botox injections about the potential risks and alert them to possible warning signs of severe
adverse reactions.
How are the Botox manufacturers responding to this investigation?
Allergan, the company that manufactures Botox and Botox Cosmetic, fully supports the investigation and
is working with the FDA to ensure that it has all of the information needed for a thorough review. The company stands by the
safety of its product.
"Since its approval, over a million people have been treated with
Botox Cosmetic," said Sef Kurstjens, MD, chief medical officer for Allergan, in a written statement. "In its entire
history, there has never been a single reported death where a causal link to Botox Cosmetic was established."
In addition, Solstice Neurosciences, the manufacturer of Myobloc, stated that it fully supports the FDA
review of Botox and remains committed to providing the agency with any information it needs.
Did
any of the reported adverse effects occur in people using Botox to reduce fine lines and wrinkles?
No.
The most serious adverse events occurred mainly among children with cerebral palsy who were treated for spasticity of their
limbs. This is not currently an FDA-approved use of Botox injections in either adults or children.
Were
the Botox injections defective or tainted?
No. No evidence exists that the Botox products were
defective in any way. The FDA stated that these adverse effects may have been related to overdosing. According to some reports,
these children may have been receiving a dose up to 28 times greater than the amount injected into cosmetic Botox users.
How did the Botox injection in the limbs affect these children's lungs?
The
active ingredient in Botox, botulinum toxin Types A and B, may spread from distant parts of the body to the muscles that affect
breathing. This is reflected in current product labeling.
Is Botox safe?
Yes. Very. According to both the American Society for Aesthetic Plastic Surgery (ASAPS) and its sister organization,
the American Society of Plastic Surgeons (ASPS), Botox is extremely safe. More than one million people have received Botox
injections. Year after year, Botox ranks number one among nonsurgical cosmetic procedures among both men and women. Complications
are rare; the most common side effects include bruising and numbness at the injection site, headache, nausea and flu-like
symptoms.
How can I ensure that I am safe if I decide to receive Botox injections?
Step 1. Do your research. ASAPS suggests asking your doctor the following questions before
you receive Botox injections:
- What is your board certification? (Doctors certified in either
plastic surgery or dermatology are most qualified to give Botox injections.)
- How were you trained
to do injectable treatments?
- Do you regularly provide Botox treatments?
- How many people have you treated who have a condition similar to mine?
- Will you personally
inject me? If not, what are the qualifications of the person who will?
Step 2.
Be alert to signs and symptoms of serious problems. Although serious complications from Botox are extremely rare,
their warning signs including worsening or unexpected difficulty swallowing, slurred speech, trouble breathing or muscle weakness.
Seek medical attention if any of these symptoms occur. These effects have been reported as early as one day and as late as
several weeks after Botox injections.
Are other injectables safe?
The
new investigation concerns only Botox. It does not relate to — or affect — other available injectables on the
market or in the pipeline. Each injectable has its own benefit and safety profile. Talk to your doctor about which one is
right for your needs.
What is Botox?
Botox
is produced from the bacterium Clostridium botulinum, which is commonly associated with food poisoning. In small,
diluted amounts, however, Botox can be injected directly into specific muscles, causing a controlled weakening. It has cosmetic
and medical uses.
Are there different types of Botox?
Yes. Botox
Cosmetic and Botox are both derived from botulinum toxin Type A, and Myobloc is derived from botulinum Type B. Another type
of Botox may be available someday soon. Already approved in more than 60 countries, Dysport/Reloxin, an injectable form of
botulinum toxin Type A, is moving down the pike. Stay tuned.
What are the approved —
and unapproved — uses of Botox injections?
In April 2002, the FDA approved Botox Cosmetic
for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines), but often it is used off-label
on crows' feet, forehead creases and bands on the neck. Botox is approved for spasm of the eyelids (blepharospasm), severe
neck muscle spasms (cervical dystonia) and excessive sweating (severe primary axillary hyperhydrosis). Myobloc is approved
for the treatment of adults with cervical dystonia. (It has not been tested sufficiently in children with cervical dystonia.)
Currently Botox is being studied to treat a laundry list of other conditions, from knee and hip osteoarthritis to migraine
headache and benign prostatic hyperplasia (BPH).
What is off-label use?
Off-label use refers to the somewhat common practice in which doctors use an approved medication for a reason that
has doesn't have FDA approval. This practice can be both legal and ethical in many situations.
How
does Botox affect wrinkles?
Certain wrinkles are created when nerve cells within the skin's
muscles release a chemical called acetylcholine. Acetylcholine, in turn, triggers muscle contractions that create wrinkles.
Botox blocks the release of acetylcholine, which paralyzes the muscle, stopping the contraction and erasing the wrinkle.
How long do the effects of Botox last on wrinkles?
Typically the effect
of Botox injections on wrinkles lasts three to six months.
http://www.nycdermatologist.com/
Trained in Dermatology, NYC Dermatolgy by Board Certified Dermatologist NY Dermatology Dr. Gary Rothfeld possesses the special knowledge, skills and professional capability that distinguishes him as an outstanding Dermatologist in NYC , Manhattan
, New York at NYC Dermatology by Board Certified Dermatologist. Top New York City Dermatologist, Dr. Rothfeld in Manhattan treats the most difficult cases until the
problem clears. Dr. Rothfeld, a Board Certified Dermatologist at NYC Dermatology in Manhattan, New York is caring,
detailed, and meticulous and will never give up until the problem is cleared. Dr. Rothfeld, a board certified dermatologist
in nyc who practices Dermatology in Manhattan, New York has treated many patients in the entertainment and music
industry is caring, detailed and meticulous and will not give up until the condition resolves. Dr. Rothfeld is recognized
as one of the best Dermatologists in NYC by the entertainment industry.NYC Dermatology is under the medical supervision of Dr. Gary Rothfeld, a Board Certified Dermatologist.
To enhance every aspect of your skin care, Dr. Rothfeld has personally created a superb line of cosmetic procedures..
NYC Dermatology by Board Certified Dermatologist Dr. Gary Rothfeld is a board
certified NYC Dermatologist with a New York City office in Manhattan, New York providing
expert skin care, dermatology, and cosmetic dermatology services.
A
board certified dermatologist in NYC specializing in dermatology and dermatologic surgery including state-of-the-art
cosmetic surgical procedures, Dr. Gary Rothfeld is known for his attention to body symmetry and his dedication
to meeting patients’ personal goals. His specialties include full body liposuction using the tumescent technique, facial
fat transplantation, Botulinum injection into facial lines and laser resurfacing. NYC dermatology specializes
in chemical peels, vein injections, laser, restylane, Perlane, Botox injections, JUvederm, non-surgical facelifts, collagen
implantation and treatment of skin cancer.
As an expert in
the field of dermatology and cosmetic dermatologic surgery, Dr. Rothfeld is has appeared on national television shows. Dr.
Rothfeld has also been quoted in many high profile national magazines.
Our goal at the manhattan office of Board
Certified Derrmatologist , Dr. Gary Rothfeld is to create an atmosphere of professionalism, trust and complete
patient satisfaction at the NYC Dermatology and Cosmetic Surgery Center in Manhattan, New York. Dr. Rothfeld, Dermatology
Director of NYC Dermatolgy is a Board Certified Dermatologist at NYC Dermatology who has treated many
patients in the entertainment industry. Schedule an appointment at our office which provides top of the line expert skin care,
dermatology, cosmetic dermatology services, and advanced dermatology laser treatments for cosmetic needs and medical
skin conditions. We offer a full range of services including surgery for skin cancer, laser hair removal, Botox®, the
Fractionated Resurfacing laser, Titan laser, and acne photodynamic treatments. Our main goal is to provide you with the most
effective and advanced treatment. Join the NYC Laser Center NYC Dermatology Mailing List Our periodic newsletters include
exclusive offers, educational articles, as well as free treatment & product drawings! Email: nycdermatologist@aol.com in our Media office and including different offers and many more. We offer a variety of services from
Botox® to Liposuction . Please contact us with any questions you may have or schedule an appointment online or by phone for
a consultation. Beauty Is Forever! and Dr. Rothfeld
at NYC Dermatologist has over 20 years of experience with his beauty tips.
.
During
your office consultation and examination you will be provided with a detailed plan of the treatments that will benefit
you most. NYC Laser Center NYC Dermatology top laser dermatology center offering skin care, dermatolgy,cosmetic
dermatology services, and laser treatments for sun damaged skin, acne, acne scars, rosacea, pigmentation, laser
hair removal, broken blood vessels, as well as superficial and deep wrinkles. We offer patients in Manhattan,
services including general dermatology, wrinkle fillers such as Restylane®, Captique, Perlane,Cosmoderm and Cosmoplast, Radiance® (radiesse) and Sculptra. We also offer Botox®,
Cosmelan, Velasmooth, Fotofacial, Titan laser, Refirme, and the Fractionated Resurfacing laser. in the treatment of acne,
rosacea, skin cancer and surgery. Dr. Rothfeld has taught numerous other physicians on the proper use of Botox®, medical
hair transplants, and lasers in the country. Acne Photodynamic Treatment
- Botox® - Botox® for Hyperhidrosis - Cellulite - Cool Laser - Cosmelan Depigmentation Treatment - Glycolic
Acid Peel - Fat Transfer - Fotofacial / IPL Fractionated Resurfacing Laser - Hair Loss - Laser Hair Removal - Liposuction
- - Surgery - Minimal Scar Technique - Photodynamic Rejuvenation Radiance® - Restylane® - Sclerotherapy
- Sculptra - Smoothbeam - Stretch Marks - SunFX - TCA Peel - Tattoo Removal - Titan Laser Facelift - V-beam Laser Treatments
- Velasmooth Our cosmetic surgeon includes Dermatologist Dr. Gary Rothfeld Board Certified Dermatologist
at NYC Dermatology. Our NYC dermatologist offers advanced dermatology laser treatments for cosmetic needs and medical
skin conditions. We offer our services to Manhattan , Brooklyn, Bronx, Queens locations through our Manhattan
office in NYC
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
What's new
What's new
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Site map
Copyright © 2008 Yahoo! Inc. All rights reserved.
Privacy Policy - Copyright/IP Policy - Terms of Service - Guidelines - Help
Site map
Open 7 Days A Week — Se Habla Español
NYC Dermatology - Manhattan Dermatology - Skin Institute of
New York - Skin Cancer Doctor- NYC Cosmetic Dermatology- Cosmetic Dermatological Surgery - New York City -
Board Certified Dermatologist
Manhattan Office
Dr. Gary Rothfeld
NYC Dermatology
- Board Certified Dermatologist - New York, NY
30 E. 60th St. Ste. 805
Manhattan, New York 10022
212.644.9494
1.800.BLEMISH
