The U.S. Food and Drug Administration announced an update to a previous safety alert on four botulinum toxin drug products, noting that all of them now have boxed warnings on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009.

The boxed warning cautions that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include potentially lifethreatening swallowing and breathing difficulties and even death.

These symptoms have mostly been reported in children with cerebral palsy being treated with botulinum toxin for muscle spasticity, a use of the drugs that has not been approved by FDA. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The affected products are

Botox (new established name onabotulinumtoxinA)
Botox Cosmetic (new established name onabotulinumtoxinA)
Myobloc (new established name rimabotulinumtoxinB)
Dysport (abobotulinumtoxinA) was approved in April 2009 with the boxed warning and is not making any name or label changes at this time.

No definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses (for frown lines between the eyebrows or severe underarm sweating). As well, no definitive serious adverse event reports of distant spread of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or for crossed eyes.

The revised labels also emphasize that the different botulinum toxin products are not interchangeable, because the units used to measure the products are different. To help reduce the potential for dosing errors, the botulinum toxin products have changed their established drug names (often referred to as the drugs “generic” name). Neither the brand names nor the formulations of the products have changed.

For more information

Information for Health Care Professionals

The new antiwrinkle facial filler Dysport, which could be used as an alternative to Botox, noticeably reduced frown lines between the eyes, according to users and independent reviewers in a study involving plastic surgeons at UT Southwestern Medical Center.

“Our study confirmed that Dysport (abobotulinumtoxinA) is a safe and effective tool in fighting wrinkles,” said Dr. Rod Rohrich, chairman of plastic surgery at UT Southwestern and one of the studys authors. “It also confirmed that the dosage should be tailored to ones facial muscle mass to be most effective. So its important to visit with a certified plastic surgeon to ensure the dosage is correct.”

The studys findings showed that Dysport was

* Most effective in women;
* More effective for AfricanAmerican patients;
* Longerlasting for AfricanAmerican patients;
* Less effective for people 65 and older; and
* As effective for those who had previously been injected with a form of botulinum neurotoxin type A (such as Botox).

The Food and Drug Administrationapproved study involved 816 participants with moderate to severe frown lines (called glabellar lines) at 27 centers in the U.S. The study is available online and will appear in Plastic and Reconstructive Surgery.

Study participants, who kept diaries for the first 14 days after being injected, were given the Dysport facial filler or a placebo. Surgeons injected Dysport in various levels, dependent on sex and facial mass, at five facial points. Selfassessments and assessments by independent reviewers were performed six times over a fivemonth followup period.

Eightyseven percent of people given Dysport reported a reduction in wrinkles, compared with 5 percent of patients taking placebos who reported an improvement. An independent assessment showed improvement among 85 percent of patients receiving Dysport, compared with 3 percent of patients receiving the placebo.

It was found that Dysport took effect as quickly as 24 hours, with the median time about four days. The facial filler lasted 7 percent longer in AfricanAmericans (median of 117 days, compared with 109 days in the overall population) in blinded assessments, and 20 percent longer in AfricanAmericans (129 compared with 107 ) according to selfassessments by study participants.

The study also confirmed that dosing should be adjusted according to a persons facial muscle mass. Participants with the smallest muscle mass had the largest response (96 percent) by 30 days. That rate dropped as low as 80 percent in people with the highest facial muscle masses. The study is the first to examine effects from varying dose levels, which is more common in clinical practice, rather than the standardized dosing used for FDA approval tests.

“Most studies have evaluated Dysport with a standard dosage,” Dr. Rohrich said. “This study evaluated the safety and effectiveness of different doses based on a persons specific muscle mass, which better mirrors what occurs in clinical practice. The size and use of the muscles that produce frown lines varies among individuals, so you want to customize treatment to the patients face.”

Dysport is a type of botulinum neurotoxin type A, similar to Botox. Both work by blocking nerve impulses to the facial muscles that create wrinkles. Dysport is produced by Scottsdale, Ariz.based Medicis Aesthetics. Dr. Rohrich is a member of the Reloxin Investigational Group.

Source
Russell Rian
University of Texas Southwestern Medical Center at Dallas

Using a lawn mower can be as routine as bike riding or barbeques during spring and summer months. But often, people find themselves in terrifying situations with these seemingly safe household machines. In fact, 200,000 people 16,000 of them children are injured in lawn mowerrelated accidents each year, the U.S. Consumer Product Safety Commission reports. However, lawn mowers dont “attack” on their own. Most injuries such as severed fingers and toes, limb amputations, broken bones, burns and eye injuries are caused by careless use and can be prevented by following a few simple safety tips.

The American Society for Reconstructive Microsurgery (ASRM), American Society of Plastic Surgeons (ASPS), American Society of Maxillofacial Surgeons (ASMS), American Academy of Pediatrics (AAP), and American Academy of Orthopaedic Surgeons (AAOS) have teamed up to prevent injuries and educate adults, parents, and children about the importance of lawn mower safety during National Safety Month, June 2009.

“In 19 years of practice as a plastic surgeon and microsurgeon, some of the most devastating and disabling injuries Ive treated are from lawn mower accidents,” said ASRM President William Zamboni, MD. “Its especially concerning when children are injured since most of these injuries are preventable.”

Many lawn mowerrelated injuries require a team of physicians from various specialties plastic surgery, microsurgery, maxillofacial surgery, pediatrics, and orthopaedics to properly repair them. Often, patients must endure painful reconstructive operations for months, sometimes years, to restore form and function.

“Power lawn mowers are dangerous adult tools, but many children, and sometimes adults unfortunately, see them as toys,” said ASPS President John Canady, MD. “Lawn mowing can be dangerous to the operator as well as those nearby if proper safety precautions arent taken. Physicians of this coalition often repair these heart wrenching injuries, and we feel its our duty to help people avoid these accidents in the first place.”

The ASRM, ASPS, ASMS, AAP and AAOS offer the following tips to help prevent lawn mowerrelated injuries

Children should be at least 12yearsold before they operate any lawn mower, and at least 16 years old for a rideon mower.
Children should never be passengers on rideon mowers.
Always wear sturdy shoes while mowing not sandals.
Young children should be at a safe distance from the area you are mowing.
Pick up stones, toys and debris from the lawn to prevent injuries from flying objects.
Always wear eye and hearing protection.
Use a mower with a control that stops it from moving forward if the handle is released.
Never pull backward or mow in reverse unless absolutely necessary carefully look for others behind you when you do.
Start and refuel mowers outdoors not in a garage. Refuel with the motor turned off and cool.
Blade settings should be set by an adult only.
Wait for blades to stop completely before removing the grass catcher, unclogging the discharge chute, or crossing gravel roads. (As a safety feature, some newer models have a blade/brake clutch that stops the blade each time the operator releases the handle.)

“We are pleased to be part of this lawn mower injury prevention coalition,” said ASMS President Kevin Kelly, MD. “Maxillofacial plastic surgeons treat numerous facial injuries caused by lawn mowers, particularly to children, and the effects can be devastating. Very often, we see patients who suffer significant facial injuries by items thrown out of mowers like sticks and stones.”

Source

The Soil Association is pleased to announce a new EUwide, harmonised standard for organic health and beauty products.

This is the first common standard in the world that will ensure clarity and transparency for both consumers and the trade at a time when the organic health and beauty market is experiencing extremely significant growth in 2008 UK sales of organic health and beauty products increased an impressive 69% to £27 million.

Francis Blake, director of Soil Association standards said
“This new harmonised standard is a real breakthrough for consumers and for the organic health and beauty industry and we hope it will be used as an international blue print. Application to use this standard is open to all certification bodies as of 30 Sept 2009.”

The new COSMOSstandard [1]is a result of six years work in collaboration with five other European organisations. [2] It also covers the regulation of natural cosmetics. The objective of this new standard is ambitious and goes beyond all current requirements for organic and natural cosmetics. [3]

After an international public consultation of three months (Nov 2008 to Jan 2009), the European Cosmetics Standards Working Group have now published the final COSMOSstandard online cosmosstandard.org

Current organic brands will have a 3year transition period [up to Sept 2012] if they need to alter formulations and labelling. Any new organic brands will have to adhere to these new standards immediately. [4]

Notes

[1] COSMOSstandard online cosmosstandard.org

[2] Soil Association (UK),BDIH (Germany), BIOFORUM (Belgium), COSMEBIO & ECOCERT (France), and ICEA (Italy)

[3] In the EU, all food and drink must be certified as organic before it can be sold as organic. This regulation does not extend to organic beauty products. As there is no legal definition as to what constitutes an organic beauty product products labelled as such may vary enormously in the organic content and the other ingredients they contain. A company can label or describe a product as organic even if they only contain tiny amounts of organic ingredients. Carrying the Soil Association symbol or any of the other certification marks involved in the COSMOS scheme shows consumers that the products are independently verified to strict organic standards.

[4] Five reasons to be an organic beautySafety. Our precautionary principle means that if there is any doubt about an ingredient it is banned so no parabens, no phthalates and no GM ingredients.

Avoid irritation. We ban synthetic fragrances, which have been found to cause a third of all cosmetic allergies.

Cocktail effect. Cut down on the products that you and your family use. Much of the concern is about the cocktail effect of chemicals in the different products that we use. Many women are using over 20 different products a day, bombarding themselves with hundreds of different chemicals.

Trust. Look for the Soil Association symbol on organic products to ensure that they meet our strict organic standards.