12.06.2008 - Swissmedic, Swiss Agency for Therapeutic Products, is issuing a warning about the dangerous side effects of the "anti-wrinkle" treatment botulinum toxin. The reason for doing so is an increased problem with the non-controlled use of products using this active substance in cosmetic "off-label use". This means the use of medicines for purposes outside the scope of what is permitted in the information relating the medicine. The muscle-paralysing effect of the nerve toxin type A botulinum toxin is increasingly used in Switzerland for cosmetic treatments for any kind of skin wrinkles. It use for this purpose is frequently and falsely claimed by commercial suppliers to be a simple, uncomplicated cosmetic treatment by means of an extremely minor procedure.
There are, however, medically useful and justified uses for botulinum toxin, and particularly for the treatment of neurological disorders.
In accordance with Art. 26 of the Swiss Law on Therapeutic Products (LPT), a physician may prescribe medicines when the patient's state of health is known. Because of the mandatory obligation to provide care, the physician must take into account both the law and the current status of medical science. Within this framework, "off-label use" of medicines can often be useful in order to treat patients. The decision to do so is based on the physician's liberty to select appropriate treatment.
The responsibility for prescribing a medicine beyond the scope of application approved by Swissmedic is born solely by the physician treating the patient. For Swissmedic, it is at the least questionable whether cosmetic "off-label use" would be in line with the legally required obligation to provide care. Such treatments are often considerably played down in advertising claims and even recommended as a preventive measure for women as of age 30. In Switzerland, the medicines Dysport®, Botox® and Vistabel® with botulinum toxin as their active substance are authorised for various medical uses. They are classified as being in dispensing category A and thus available on prescription only. Of the three medicines, only Vistabelâ includes a cosmetic indication, although exclusively for the treatment of severe forehead wrinkles between the eyebrows (glabellar folds) in adults. The medicine is not authorised for all other cosmetic purposes and the Swiss Regulatory Authority, Swissmedic, has thus not acknowledged its favourable risk / benefit ratio. It goes without saying that safety is a particularly important aspect of cosmetic treatments.
In addition, this product should only be used by specialised physicians who have the necessary experience with applying type A botulinum and master the techniques required. When applying the product in the throat / neck area, the substance can spread and lead to problems with swallowing and breathing. If large quantities reach the bloodstream, paralysis may occur. In the worst case, there is a danger of suffocation. In this connection, Swissmedic refers to reports by the US Food and Drug Administration (FDA), the national regulatory authority.
Further information:
Botulinum toxin is a complex of several proteins. It blocks the transmission of stimuli from the nerve cells to the muscles, relaxing or paralysing the muscle. As a medicine, it is used for example to treat neurological diseases with movement disorders and muscle cramps (spasticity).
The efficacy of Type A botulinum toxin is tested using the so-called Mouse LD50 assay. During animal testing, the quantity of a substance that leads to the death of half the animals can be established (DL50 = fatal dose for 50% of the animals). Mice are given the substance in various doses by abdominal probe. New animal tests are required for each batch of the dose, because the results cannot be transferred.