“Galderma, the leading pharmaceutical company in dermatology, and Ipsen (Paris:IPN), an innovation-driven international specialty pharmaceutical group, announced that Azzalure? (botulinum toxin Type A manufactured by Ipsen), a muscle relaxant specifically developed for aesthetic use, has received a marketing authorization in France from the Agence Fran?aise de S?curit? Sanitaire des Produits de Sant? (AFSSAPS).
The marketing approval is for the temporary improvement in the appearance of moderate to severe glabellar lines seen at the frown (vertical lines between the eyebrows), in adult men and women aged 65 years and under, when the severity of these lines has an important psychological impact on the patient. The approval was based on several clinical trials involving more than 2,600 patients, which confirmed the safety and efficacy of Azzalure?.”
Azzalure is what they call Dysport in France, which we call Reloxin here in the US. Check back soon for a genealogy chart explaining all of these products and how they intertwine.
2. Heads Up, Botox [NY Times]
“To be honest, if you just talk about aesthetics, there are no good comparative trials on Dysport and Botox,? said Dr. Berthold Rzany, an author of ?Botulinum Toxin in Aesthetic Medicine? and the director of evidence-based medicine at Charit?, the university hospital in Berlin, Germany. Only small studies exist, Dr. Rzany said, adding that at least 300 participants would be needed to prove that one of the drugs lasts longer. Choosing a longer-lasting product would matter to consumers because both drugs are expensive. In England, a visit for Botox or Dysport costs roughly $250 to $430, said Dr. John Curran, the former president of the British Association of Cosmetic Doctors. (There is no information yet about how it might be priced in the United States.)
3. Bronx Woman Dies After Botched Plastic Surgery [Newsday]
“Siordaliza Pichardo only wanted to add shape to her thighs and buttocks. Now, the Bronx mother of two is dead, killed during a botched plastic surgery procedure, authorities said.
…But after further tests were conducted and police were consulted, the ME on Tuesday declared the case a homicide and concluded the mother of two died of a “silicone pulmonary embolism,” with the silicone clotting in her lungs. The ME also said the injections were performed by a “nonmedical, unlicensed person.”
Yet another tragedy caused by unlicensed practitioners.