Botox is Safe -- Italian Study Flawed, Says Beverly Hills Doctor

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Doctor Simon Ourian, a leading authority in the use of BOTOX® in the U.S. rejects the recent BOTOX® study. 7 reasons why BOTOX® is safe.

BOTOX® has been used safely for more than 25 years with few complications. This fear is completely unwarranted and largely alarmist

Dr. Simon Ourian of Epione in Beverly Hills criticizes the claims made by the Italian National Research Council's study that BOTOX® can move to the brain from the injection site. "BOTOX® has been used safely for more than 25 years with few complications. This fear is completely unwarranted and largely alarmist," explains Dr. Ourian.

The Journal of Neuroscience article (A New Reason to Frown; April 12), draws inappropriate conclusions about the medical product BOTOX® (Botulinum Toxin Type A), how it works in treating millions of patients suffering from severe conditions and incorrectly calls into question its 19-year safety record. "Although the study makes for great eyebrow raising news the science behind the study is largely flawed," says Dr. Ourian.

  • The article centers on a single Italian rat study that has no proven relevance to the use of BOTOX® in humans.
  • Importantly, the study authors did not use BOTOX® in their research. Instead, they used a research-grade, laboratory preparation of botulinum toxin that is not suitable for human use. This study material is substantially different than BOTOX® and reacts differently in the body.
  • Furthermore, the dosing of study material injected in the whisker pad of rats was approximately 150 times higher (per body weight) than the approved dose for BOTOX® to treat wrinkles (i.e., glabellar lines).
  • Researchers did not directly detect the laboratory material in the rats; instead, they inferred its presence through the use of a marker. However, this marker has not been previously used in peer-reviewed research in this manner and is not validated. The use of this uncharacterized marker brings the study and its conclusions into question, since the study's results entirely depend upon it.
  • BOTOX® was first approved by the FDA for medical use nearly 20 years ago, has been extensively studied, and is the subject of thousands of scientific papers.
  • The data from this single rat study are inconsistent with prior research and the literature on the mechanism of action of BOTOX®. There are insufficient data to generalize the results of this one animal study to the use of BOTOX®.
  • BOTOX® has brought relief to millions of patients worldwide suffering from often severely debilitating medical conditions. It is inappropriate to create unnecessary concern and confusion among those who need this treatment by mischaracterizing the established safety of this drug.

"There is no chance that the results of this study could occur in a human. The doses used for cosmetic application are much smaller and the effects more localized. I always support additional research, but this study contradicts previous findings," says Ourian. "BOTOX® is the safest anti-aging treatment out there, I use it myself and recommend it to all my patients."

Dr. Ourian's Epione Medical Center, located in Beverly Hills' "Golden Triangle," is among the world's most comprehensive and state-of-the-art surgery centers. Dr. Ourian has been a pioneer for laser technology and non-invasive aesthetic procedures such as BOTOX®, Restylane®, Radiesse®, Lipotherapy, and CoolaserTM. For further information, please visit http://www.epione.com.

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