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Botox: Warnings

World-renowned Dermatologist Warns Public of Botox Dangers

  k
Beverly Hills, CA: Dr. Arnold Klein, a world-renowned dermatologist is making it his mission to tell the public about the dangers of Botox, one of the most popular cosmetic treatments that almost everyone is familiar with in some form. Behind Viagra, Botox is the second-most popular prescription drug in the world and has served as a more cost-effective alternative to having cosmetic surgery.

Dr. Klein has stated that physicians need to be trained and educated on the proper use of Botox and that the FDA needs to be much tougher in protecting the public. There has been evidence of Botox being used improperly and he alleges that Allergan, the manufacturer of Botox, has misrepresented the data they have on the drug.

Botox TreatmentDr. Klein reviewed a 2003 study that was submitted to the Dermatologic Surgery journal by foreign doctors doing work for Allergan. The review had to deal with diluting Botox. What the author of the review was trying to show was that certain levels of dilution not detract from the safety and efficacy of the product. However, a review of the paper showed some serious issues with the manuscript, which included graphs that showed worsening of wrinkles after the Botox wore off. The study was not published due to these various issues with the paper. At a later date, the same author submitted the same study with different results. When Dr. Klein alerted the editor of the journal, he was told that the issue would be resolved.

However, the same study still appeared two years later in an edition of Dermatology Surgery that was sponsored by Allergan. The study included the data that was altered despite the statement to Klein by the publications editor that the situation would be resolved. It may have been resolved at the moment, but did not have an impact when Allergan sponsored the review. Klein stated that he felt the data was altered to benefit the pharmaceutical company at the expense of the health of the patients.

Klein later shared his concern regarding the improper dilution of the drug causing serious risks to patients such as the drug spreading to unintended areas of the body, which could cause paralysis and even death. Shortly after Klein raised his concerns, the same foreign doctor who had conducted the study that appeared in the Dermatology Surgery journal, submitted another article about the drug Myobloc, which has also been suspected of causing paralysis and death. It is injected in the same manner as Botox. Dr. Klein and another doctor were named as the authors, although they said they had nothing to do with it and had never seen it prior to it being published.

Klein's main concern is that the use of Botox is becoming more and more prevalent and is being administered by doctors other than cosmetic surgeons. Many of these doctors have hardly any training or experience with the drug, so they believe that diluted Botox is safer because of published studies with suspected altered results. Klein feels that the FDA needs to make sure that future studies that are published in American medical publications be submitted by Physicians with US medical licenses. The physician who published the reviews on both Botox and Myobloc was not licensed to practice medicine within the United States.

In February, the FDA announced that Myobloc and Botox have both been associated with swallowing issues and respiratory issues. There has been at least one death. Public Citizen, an American watchdog group, found that there have been 180 severe reactions and 16 deaths associated with Botox use in a 9 year period. There has only been one cosmetic-related death.

Black Box Warning for Botox

FDA: Cosmetic Use Appears Safe
By Salynn Boyles
WebMD Feature
Reviewed by Louise Chang, MD

April 30, 2009 -- The FDA announced today that it will require black box labeling on Botox and similar products warning of a rare but potentially life-threatening complication when the effects of the toxin spread far beyond the injection site.

The move stems from reported hospitalizations and deaths attributed to botulism poisoning in children with cerebral palsy treated with botulinum toxin for muscle spasms.

Hospitalizations requiring ventilation have also been reported in adults treated with botulinum toxin for involuntary muscle movement and frequent neck spasms. Deaths among adults are suspected but could not be confirmed.

No serious side effects related to the distant spread of toxin have been confirmed among people who have used Botox and the related product Myobloc for cosmetic purposes.

Cosmetic Use Appears Safe

Such uses generally require much smaller doses of the toxin. Cosmetic use appears safe if the products are used as directed, an FDA official told reporters Thursday.

“If the drug is given the way it is intended, as described on the label, the risk of distant spread may well be zero,” said Ellis F. Unger, MD, of the FDA’s Center for Drug Evaluation and Research.

Unger declined to speculate on the number of hospitalizations and deaths from botulism poisoning that have occurred in Botox and Myobloc users.

But the health advocacy group Public Citizen, which petitioned the FDA for the black box warning, claims that as of early last year the drug was responsible for 180 serious adverse events and 16 deaths in the United States.

The signs and symptoms of distant spread and botulism poisoning in Botox users are many, including unexplained sudden loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing or swallowing, double vision, blurred vision, or drooping eyelids.

Action Affects New Botox Rival

The FDA action affects Botox and Botox Cosmetic, both sold by Allergan Inc.; Myobloc, sold by Solstice Neuroscience; and a third botulinum toxin product -- Dysport (marketed by Ipsen) -- approved just yesterday by the FDA.

The products are approved to treat uncontrolled muscle contractions in the neck and shoulder -- a condition known medically as cervical dystonia. Approved cosmetic uses include treating frown lines between the eyebrows and excessive underarm sweating.

The black box warning was just one of several moves the FDA announced regarding the products.

The manufacturers will also be required to:

  • Inform users in writing about the potential risk for distant spread at the time of injection.
  • Warn doctors and patients about the risks associated with substituting one botulism product for another. The products have different dosing units, which are incompatible, so switching products can result in dangerous overdosing.
  • Follow a group of children and adults using Botox, Myobloc, or Dysport off-label to treat involuntary muscle movement and submit safety data to the agency.

Action Affects New Botox Rival continued...

Although there is little concern about the safety of Botox and the other products for approved cosmetic uses when they are used as directed, the FDA is requiring these patients to be warned of the risks anyway.

Unger said these users could be at risk if they don’t use the products as directed.

“It is not unusual for patients who use these products for cosmetic purposes to get more injections at more sites than is recommended,” he said.

In a statement issued Thursday afternoon, Allergan noted that reports of serious adverse events have generally been confined to sick patients who received high doses of Botox for therapeutic, and not cosmetic, reasons.

Allergan spokeswoman Caroline Van Hove highlighted Unger’s statement to the media that no adverse events related to distant spread of the drug had been confirmed in patients using Botox as the label indicates for cosmetic reasons.

“Allergan will work with the FDA to appropriately update the label for Botox and Botox Cosmetic in light of the FDA’s conclusion,” she said. “In the interim, caution should be exercised if treating neurologically vulnerable patients with high doses of Botox.”

     


      

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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

  •                                                          212.644.6454 

Dear Friends
 
Our goal at NYC Dermatology is to be the Tiffanys of Skin
Care. I personally see every new patient who visits our office. I am not just a physician, I am a Board Certified DermatologistMy goal is, quite simply, to provide the type of dermatologic care which I  would seek for my own family. This is a very important point, since physicans often use the phrase "Doctor's Doctor" to refer to those individuals who typically are selected by physicians themselves for personal care. I am confident that my practice fully meets that definition. This is the type of 5-star care and service that our patients expect, deserve and receive. I treat every patient the way I would want to be treated: with courtesy, dignity and respect. I carefully listen to their skin-care concerns and offer a variety of options including a treatment plan that I believe will give them the best results and the best dermatologist. We also support our patients with a very fine medical staff . Please take a moment to explore our top of the line winning website. My philosophy is simple…Experience Counts and Quality Matters. Please allow me to solve your skin problems.  After all, at NYC Dermatology , our philosophy is if you look great you will feel great with gorgeous skin.”
 
Best Regards,
 
Dr. Rothfeld
 

  
 
 

 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

 

Sun Protection

 

Ultraviolet radiation is the major cause of skin cancer, including melanoma. It is important for everyone to be aware of its damaging effects and take measures to avoid overexposure.

 

Although many people enjoy the appearance of tanned skin and think it looks "healthy," tanned skin is damaged skin. The ultraviolet radiation in sunlight penetrates the deepest layers of the skin where it harms the cells. The body responds by making more pigment (melanin) to try to protect itself, but the damage has already happened and may be permanent. The more exposure you have to the sun, the more likely you are to develop skin problems later in life.

Ultraviolet Radiation

The damaging part of sunlight is called ultraviolet radiation, or UV rays. It is categorized into three types:

  • UVC rays (wavelengths = 200 nm to 290 nm) are the shortest and most powerful of the UV rays. UVC is the most likely to cause cancer if it reaches skin. Fortunately, most of it is absorbed by the ozone layer in our atmosphere. However, there is concern that a thinning of the ozone layer may be causing more UVC to reach the earth's surface.
  • UVB rays (wavelengths = 290 nm to 320 nm) are less damaging than UVC, but more of it penetrates to the earth's surface. It is the most common cause of sunburn and skin cancer. UVB is particularly strong at the equator, at high elevations, and during the summer.
  • UVA rays (wavelengths = 320 nm to 400 nm) are the least powerful of the UV rays, but they are present all year and can penetrate windows and clouds.

Sun Protection

The first and more effective way to avoid sun damage is to stay out of tthe sun as much as possible.

If you cannot avoid being exposed to sunlight, there are five basic defenses that you should keep in mind when you go outdoors:

  • Avoid peak hours of sunlight
  • Sunscreen
  • Clothing
  • Sunglasses
  • Shade

Avoid Peak Hours of Sunlight (UV Index)

In general, UV rays are the greatest between 10 a.m. and 4 p.m. It is best to avoid the outdoors during these hours without protection, particularly during summer, in tropical regions, or at altitude. During this time, you should pay close attention to the appropriate use of sunscreen, clothing, sunglasses, and shade.

You can obtain an accurate measure of the amount of UV rays in your area by looking up the Ultraviolet (UV) Index. The UV Index is like a weather forecast. It provides a report on the amount of damaging UV rays that are expected to affect a region on a particular day. The UV Index changes day to day according to time of year, cloud cover, atmospheric ozone, and other factors.

The following table is a breakdown of the UV Index. A high UV Index number means that you are at greater risk of being exposed to ultraviolet radiation. You should take special care to avoid outdoor exposure to sunlight when the UV Index is moderate or greater.

  • 0 to 2 = Minimal
  • 3 to 4 = Low
  • 5 to 6 = Moderate
  • 7 to 9 = High
  • 10 or more = Very high

The UV Index can be found on our Website or in local papers, usually in the weather section.

Sunscreen

There are several factors to consider when selecting the right sunscreen. (See the Sunscreens handout for more information.)

Sun protection actor (SPF) - Sunscreens are rated by the amount of protection they provide from UVB, measured as the "sun protection factor" or SPF. Sunscreens with higher SPF provide greater protection from the sun. It is best to use sunscreens that offer a minimum SPF of 15.

Broad-spectrum sunscreens - It is best to use a sunscreen that can protect you from both UVA and UVB rays. These are called "broad-spectrum" sunscreens. 
Most of the original sunscreens blocked only UVB, but increased awareness of the damage caused by UVA has lead to the development of ingredients that protect against UVA too. Broad-spectrum sunscreens combine ingredients to provide a product with greater protection.

Common sunscreen ingredients that  provide protection from UVB rays:

  • Cinnamates
  • Octocrylene
  • PABA (para-aminobenzoic acid)
  • Padimate O and Padimate A (Octyl Dimethyl PABA)
  • Salicylates

Common sunscreen ingredients that  provide protection from UVA rays:

  • Avobenzone (Parsol 1789)
  • Benzophenones (oxybenzone, dioxybenzone, sulisobenzone)

Sunblocks - "Physical" sunscreen ingredients lie on top of the skin and work by reflecting or scattering UV radiation. They are particularly useful for people who are sensitive to the ingredients found in other sunscreens. Sunblocks often contain one or more of these ingredients:

  • Zinc oxide
  • Titanium dioxide
  • Iron oxide

Although past formulations were unsightly (often leaving a white film on the skin), newer "microfine" formulations are invisible after being applied. Microfine titanium dioxide is effective at protecting from both UVA and UVB rays.

Water resistance - Sunscreens are classified as "water-resistant" if they maintain their protection after two 20-minute immersions in water. They are classified as "waterproof" if they maintain their protection after four 20-minute immersions. You should seek a water-resistant or waterproof sunscreen if you will be participating in water sports, such as swimming or water skiing, or will be actively sweating.

However, independent testing has shown many products do not perform well in the real world. So it remains a good idea to apply sunscreen every time you leave the water, or frequently if you are actively sweating.

Using a Sunscreen

Sunscreen should be applied evenly and liberally on all sun-exposed skin within 30 minutes before going outside to give sunscreen time to take effect. (Sunblocks are effective immediately after being applied.) Sunscreens should be reapplied every two hours or following swimming or sweating. Apply sunscreen generously and reapply frequently at least every two hours.


The chemicals may lose effectiveness over time, so it is important to throw away sunscreen that is past its expiration date or is over two years old.


No sunscreen is 100% effective; take additional measures to avoid the damaging effects of the sun's rays.

Clothing

Clothing can provide excellent protection from the sun. However, not all clothing is protective. A thin, wet, white t-shirt will provide almost no protection from UV rays. When selecting clothes for sun protection, consider the following:

  • Cover your head, shoulders, arms, legs, and feet.
  • Use a hat that is broad-brimmed (brim should be at least four inches wide).
  • Wear fabrics that are thicker or with a tight weave; these allow less sunlight to penetrate the skin.
  • Wear darker-colored clothes that absorb more UV rays.
  • Wear clothing made from nylon or Dacron because it is more protective than cotton.
  • Avoid remaining in wet clothes because wet fabric may allow more UV rays to penetrate the skin.
  • Wash clothing with chemical absorbers to increase their protectiveness.
  • Some clothing comes with a UPF rating that stands for "Ultraviolet Protection Factor." This measures the ability of the fabric to block UV radiation from penetrating to the skin. A fabric with a UPF 15 allows only 1/15th (6.66%) of the UV radiation to penetrate your skin as compared to uncovered skin.

Garments fall into 3 categories:

  • Good protection: UPF = 15 to 24
  • Very good protection: UPF = 25 to 39
  • Excellent protection: UPF = 40 to 50+

Choose clothing with a UPF rating of at least 15. Keep in mind that the UPF of a garment will decrease over time as the fabric wears.

Sunglasses

Overexposure to sunlight can cause cataracts and macular degeneration, a major cause of blindness. Sunglasses can provide protection. However, not all sunglasses are of value. A darker lens itself does not guarantee protection. Look at the label to ensure that the glasses provide UV protection. Sunglasses should be large enough to shield your eyes from many angles. Look for sunglasses that are described as blocking 99% or 100% of UVA and UVB. The glasses may also be described as providing UV absorption up to 400 nm.

Shade

If possible, remain in the shade when outdoors. Keep in mind that shade does not provide full protection from the sun because UV rays can bounce off reflective surfaces, such as sand, snow, water, concrete, or even porch decks. In addition, some fabrics used as shade devices, such as parasols or umbrellas, may not provide sufficient protection. If you seek shade under a cloth, look for a fabric that is thick, tightly woven, and dark-colored.

Clear window glass provides protection from UVC and UVB, but not UVA rays. If you are frequently exposed to sunlight while driving, the plastic interleaf of your windshield (which prevents it from shattering) can help block the light, but side windows have no such protection. Non-drivers can make use of additional window shade devices. Drivers in some states may be able to use darkly-tinted glass in the side windows, but this is illegal in some states.

Summary

  • Avoid the sun when its UV rays are strongest, between 10 a.m. and 4 p.m.
  • Use a broad-spectrum sunscreen with SPF 15 or greater. Apply it 30 minutes prior to being exposed to the sun and reapply every two hours. Consider using a water-resistant sunscreen if you will be active (sweating) or in the water.
  • Use a sunblock on your lips.
  • Wear a broad-brimmed hat when outdoors.
  • Wear sunglasses.
  • Wear tightly woven, dark clothing to cover your arms, legs, and feet.
  • Stay in the shade when possible.
  • Avoid reflective surfaces, such as water or snow.
  • Avoid sunbathing.
  • Don't be fooled by cloudy days since damaging rays can penetrate clouds.

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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

  •                                                          212.644.6454