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Posts Tagged ‘dysport’

Another botulinumtoxinA Wrinkle Treatment Enters the Market: Notes from a San Francisco Bay Area Dermatologist

Thursday, July 28th, 2011

Xeomin (incobotulinumtoxinA) joins the Botox (onabotulinumtoxinA) and Dysport (abobotulinumtoxinA) market as the latest injectable treatment for wrinkles.

According to Dermatology Times, the Food and Drug Administration (FDA) has approved Xeomin (incobotulinumtoxinA, Merz Aesthetics) for temporary improvement of moderate to severe glabellar lines.

According to a Merz statement, the approval is based on the results of two multicenter U.S. clinical trials involving 547 healthy adults. In both studies, Xeomin injections significantly improved the appearance of glabellar lines in 30 days when compared with placebo. Headache was the most common adverse reaction observed.

Under the brand name Bocouture, Xeomin is already approved in 14 European countries including Germany, the United Kingdom, France, Italy and Spain. It was FDA-approved in 2010 for the treatment of cervical dystonia and blepharospasm.

Xeomin will be available nationwide in the spring of 2012, Merz officials said.

 

Botox Cosmetic is Still Safe! Notes from a San Francisco Bay Area Dermatologist

Friday, August 14th, 2009

The new FDA warnings on Botox have caused undue alarm.  The FDA recently approved a new warning on Allergan’s Botox and a similar product about the possibility of life-threatening breathing and swallowing problems.  It is important to know that these warnings are referring specifically to off label medical uses where extremely high doses of Botox are used to treat spastic conditions in children with Cerebral Palsy.

Botox Cosmetic is still FDA approved for the treatment of glabellar or “frown lines” and is administered in much smaller doses for this aesthetic use.  The doses of Botox are significantly greater for medical uses than for an aesthetic procedure.

More than 13 million aesthetic procedures with Botox Cosmetic have been administered since the product was FDA approved in 2002 in the United States for treatment of moderate to severe “frown lines” in adults 18 to 65.  Botox Cosmetic, when used in the indicated doses and administered to specific small muscle groups has not been linked to serious side effects.

There is a new botulinum product called Dysport on the market that is also approved for aesthetic procedures.  Its dosing is slightly different than Botox Cosmetic.  To avoid confusion, the FDA wants to call attention to the different dosing instructions with Dysport and decrease the risk of any side effects.  This and increasing off label use of Botox to treat conditions ranging from muscle spasms to Raynaud’s disease prompted the FDA to enact new warnings.

When administered by a professional for aesthetic procedures, Botox is still an extremely, safe, simple effective way to smooth wrinkles and lines.

 

Important Info about Botox and Dysport (Reloxin)

Monday, May 4th, 2009

The FDA has recently approved the cosmetic use of a new brand of Botulinum Toxin Type A, known as Dysport or Reloxin.  Dysport is a competitor to Botox, which up until now was the only FDA approved wrinkle reduction product of its kind.   Dysport claims to take effect more quickly and could potentially be lower in price than Botox.  It will hit the cosmetic market within the next two months.

The approval of Dysport comes at a time when the FDA has issued new labeleling requirements for all botulinum based drugs, including Botox.  Both products must now carry labels warning that they have the potential to spread to other areas of the body after injection with possibly serious risks.  I want to assure my patients that when used as directed by a trained professional the cosmetic use of these products is safe! The new labels are a reaction to unapproved or “off-label” use, such as overdosing to treat leg or arm muscle spasms.  This unapproved medical use should not be confused with the cosmetic application.  The small amounts used for wrinkle softening and underarm sweating (hyperhidrosis) are safe and not linked to any harmful migration or serious adverse reactions.  I am more than satisfied with the long-term safety studies of this material for aesthetic purposes.  If you have any questions, please don’t hesitate to contact the office.

 

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