Aesthetic Products & Off Label Use

Many of the injectable products used for aesthetic effects are unregistered in Malaysia.


This is because the great number of these are not originally prescribed for aesthetic use in the first place. Only through experimentation & novel applications at some clinics in some parts of the world did we discover that these products do have these 'side' uses. These 'side' uses are termed 'off label' because they are not labelled as their indicated use. These 'off label' applications became popular amongst the pioneer users & practitioners. Only much later did the world discover these novel applications & uses.


For example, Lipostabil being registered in Germany is indicated for the treatment of high cholesterol and to prevent fat embolism. It is not intended for fat melting purposes. In the case of Lipostabil, the fat melting effect (also termed 'lipo-dissolve') that may be achieved by Lipostabil has not gone through the whole clinical trials of safety and efficacy other than for its original intended precription. And as such the lack of studies on its efficacy & safety profiling, they are not registrable for other uses.


The same goes with vitamin C injections. These are actually indicated for use in the cases of scurvy or deficiency of vitamin C. However the world discovered that the administration of vitamin C does have an effect on suppressing melanin formation thus resulting in lighter skin tones. Although no formal clinical trials for this effect was ever conducted, the experience of users and its spread through word of mouth eventually gain acceptance to a great number of people. Although some doctors remain skeptical, as they should be because doctors are trained not to accept something which remains outside what is thought to be scientific. Without such clinical trials involving careful monitoring, measuring, documenting and statistically analysing the results whilst removing the placebos and biases, these uses cannot be included in what is accepted to be scientific, and as such, doctors will remain skeptical as they should.