Botulinum Toxin Wars

Now that Dysport, which was going to be named Reloxin, has been approved by the FDA, you can expect to see extensive advertising by Allergan (Botox) and Medicis (Dysport) implying that theirs is the better product. Dysport has been used for years in Europe and Canada, and the differences between the products are less than the differences between fillers. Although they both have Botulinum Toxin A as their active ingredient, they are manufactured differently and there are some differences in their makeup and action.

Laser Assisted Liposuction: Cholesterol Reduction?

There are a number of laser assisted liposuction machines on the market. None of them have demonstrated any clear advantage over traditional liposuction, although the claim is that they produce more skin tightening than traditional liposuction. When one researcher proposed looking at this scientifically, the laser company he was working with refused to let him proceed.
Now a company studying another low level laser liposuction device has seen reduction in serum cholesterol and triglyceride levels two weeks after treatment with their device (LipoLaser). In a group of 19 patients the mean cholesterol level fell by 19 mg/dL, with the mean LDL (bad) cholesterol reduction of 14 mg/dL.

LED Phototherapy: Hype or Hope

The use of light emitting diodes (LEDs) to improve skin tone and texture has gained prominence in some offices and spas. Previous studies were performed by manufacturers and suggested some improvement in fine lines. Recently there was an independant study evaluating the effectiveness of Gentlewaves, one of the most commonly used units.

Botulinum Toxin Alert: New Labeling for Botox and Others

The FDA has recently released additions to the labeling requirements for all Botulinum Type A Products. These actions are a result of adverse events that have occurred in both approved and unapproved uses where the toxin has spread beyond the injection site causing symptoms of botulism (difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression). The postmarketing case reports of these adverse events occurred primarily in children being treated for muscle spasticity due to cerebral palsy, and in adults being treated for spasticity or cervical dystonia.
It is important to note that, according to the FDA, “Definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of Botox at the labeled dose... have NOT been identified."

The FDA also has informed the manufacturers that development of a Risk  Evaluation and Mitigation System is necessary. The System would include a Communication Plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The System also would include a Medication Guide that explains the risks to patients. Once it is developed, dermatologists will distribute the Medication Guide to patients at the time of injection.

The bottom line is that this is an administrative change, but it does not indicate that there is any new information or that there has been any change in the previously understood potential side effects of Botulinum A Toxin. It is likely that the release of these guidelines will hasten the approval of Reloxin, one of several new Botulinum A Toxins in the pipeline, and the one that is closest to release. The appearance of competitors to Botox will almost certainly bring lower prices to consumers.

Gerald N. Bock MD

California Skin & Laser Center

Stockton & Lodi, CA