Regarding the Recent News Coverage on Botulinum Toxin

 

As many of you are aware, there has been substantial coverage on botulinum toxins, specifically Botox and MyoBloc in the media.  Public Citizen, a national, nonprofit consumer advocacy organization reviewed 180 reports submitted to the Food and Drug Administration by manufactures involving patients injected with Botox or MyoBloc. The report detailed cases of muscle weakness, difficulty swallowing or aspiration pneumonia. Public Citizen asked U.S. authorities to require the strongest possible warning, highlighted in a “black box,” on Allergan Inc’s Botox and Solstice Neurosciences Inc’s MyoBloc.

Both Allergan and Solstice have warning labels on their products about the potential side effects. Physicians inform their patients about these side effects and what to do if the symptoms are severe. This ensures the situation can be assessed immediately and the appropriate action can be taken.

The Food and Drug Administration is currently reviewing safety data from clinical studies submitted by drugs’ manufacturer, as well as post-marketing adverse reports and medical literature. After completing a review of the data, the FDA will communicate to the public its conclusions, resulting in recommendations, and any regulatory actions.

Botulinum toxin is a safe product and is the best form of treatment to control the symptoms of spasmodic torticollis or any other form of dystonia. Since Botox and Myobloc have been FDA approved for treating cervical dystonia, thousands of injections have been administered improving the quality of life of the patient.

The FDA is not advising health care professionals to discontinue prescribing these products.

Mark Your Calendars!

 

The 2008 NSTA Symposium will be held in

Tempe, Arizona

on

September 27 and 28

 

 

 

2007 NSTA Symposium in

Orlando, Florida

October 13 and 14.

 

 

Symposium attendees listen as Dr. Drake Duane makes his presentation entitled,

"Interesting Attributes of People with Torticollis and Methods of Their Medical Treatment"

Saturday Afternoon in the Hilton Garden Inn restaurant as lunch is being served. Everyone spent time being reacquainted with old friends and making new ones.

 

Everyone had a nice time socializing and relaxing for an hour after the mornings presentations. 

 

Dr Carlos Arce spending time with a symposium participant shortly after his presentation to answer questions personally.

 

The display provided by Allergan Neurosciences. Representatives were present to hand out Information brochures and answer questions.

 

 

The Allergan representatives brought E.L.V.I.S, a life like model that is used to help physicians identify the injections sites when performing the chemical denervation procedure.

 

Cervical Dystonia Study Website is Launched

A clinical research study for cervical dystonia is currently recruiting participants. A website has been launched for individuals interested in learning more about the study at  www.dystoniastudies.com. The website includes an overview of the study, eligibility requirements, as well as a brochure with more detailed information about the study.

Researchers at study centers across the country are seeking individuals age 18 to 75 with a clinical diagnosis of cervical dystonia who have previously been treated for the condition, or individuals interested in learning if they have cervical dystonia who have not yet received treatment. The purpose of this research study is to assess the safety and effectiveness of an investigational drug in controlling the sustained muscle contractions which lead to the abnormal head movements and postures.  The investigational drug is delivered by injections into the affected muscles.

Patients with cervical dystonia experience abnormal squeezing and twisting muscle contractions in the head and neck area. This results in sustained muscle contractions which cause abnormal positions and posturing. Excessive or exaggerated muscle development is present in almost all patients. 

The study, sponsored by MERZ Pharmaceuticals GmbH, will determine if the investigational drug reduces and/or eliminates the extreme muscle tightening that leads to abnormal positioning and posturing. Two different doses of the investigational drug will be compared to placebo (inactive solution). 

For more information about the study and/or to determine your eligibility, visit www.dystoniastudies.com or call toll free 1-800-984-0408.