The market of cosmetic anesthetics for the skin – what has changed over the year?
A year ago, an article was published on 1nep.ru Portal about the composition of some skin anesthetics used in cosmetology, as well as how the market for surface anesthesia is regulated by law, what risks are associated with the use of unregistered drugs for the patient and the doctor.
Has the situation changed over the year? Has the application anesthesia business become more legal and safer for patients? Below we present the results of an investigation of journalists from the newspaper Argumenty i Fakty.
An analysis of the Internet space showed that cosmetic anesthetics are still available to customers in numerous online stores.
To register a drug, a company must conduct a series of laboratory and clinical trials. If the original drug was approved by the FDA (USA), EMA (European Union) or the Ministry of Health (RF), then only the third phase of clinical trials is enough. If not, then the manufacturer will have to start from the first phase, which is twice as expensive as the already sky-high price tag. Registration of the drug turns into a long and expensive process, which drags on for several years and requires tens of millions of rubles.
Currently, the FDA approved combinations: lidocaine 2.5% + prilocaine 2.5%, as well as lidocaine 7% + tetracaine 7% (only the first combination is officially available in Russia).
But on the market there are other combinations of these anesthetics in various concentrations, as well as containing benzocaine and epinephrine (adrenaline). Some of these funds have declarations of conformity under the regulation of the Customs Union and are sold as cosmetics.
This situation became possible for several reasons:
Rospotrebnadzor gave the functions of quality control and compliance with the declared composition to private certification centers and laboratories, and the responsibility for submitting documents was assigned to the manufacturer.
The process of certification of a cosmetic product was simplified, the procedure itself became cheaper in comparison with the registration of drugs and medical devices (approximately 12-14 thousand rubles).
There are no laboratories in Rosaccreditation that are able to check cosmetics for the presence of medicinal substances in them.
All this leads to the fact that manufacturers of approved combinations of anesthetics face tightening and difficulties in obtaining a license.
What does this lead to?
The second time we (AiF reporters. – Note. Editorial 1nep.ru) were convinced that when buying cosmetic products, you can not rely on the information on the package. Manufacturers are still misleading buyers.
This is what was announced in the five new test participants and what the manufacturers actually put in the box.
The following painkillers came into view:
The test was conducted by the Center for Chemical Research.
Laboratory studies showed the following results:
in the composition of sample No. 1 – lidocaine 4.82%;
in sample No. 2, lidocaine 4.31% and prilocaine 5.17%; epinephrine is absent;
in the composition of sample No. 3 – 4.00% and 3.23%; benzocaine is absent.
in the composition of sample No. 4, lidocaine 11.59%;
in sample 5, lidocaine 2.07% and prilocaine 2.62%.
As you can see, all drugs contained lidocaine, three – a combination of lidocaine and prilocaine. But in the absence of quality control, the amount of active substances did not match the information on the package. In all combination preparations, the proportion of lidocaine and prilocaine was different from 1: 1, although it was considered the best for enhancing the action of one anesthetic by another [Therapeutics and Clinical Risk Management 2006].
We see that in comparison with the combination of lidocaine + prilocaine, approved by the FDA and the Ministry of Health of the Russian Federation, some manufacturers put in a greater amount of substance, believing that such a tool will have a better effect. The optimal concentration for this combination was found more than 30 years ago, the results can be seen in the graph below.
lidocaine and prilocaine
The rate of release of lidocaine and prilocaine from the emulsion.
The graph shows the rate of release of lidocaine and prilocaine from the emulsion. At a concentration of more than 5%, the rate practically does not change. This means that efficiency remains virtually unchanged [Nyqvist-Mayer et al. 1986]. In addition, a certain area of the skin contains a limited number of receptors with which the anesthetic binds. When all free receptors are bound to the molecules of the active substance, a further increase in the concentration of anesthetic does not increase the effectiveness of the drug. All this makes increasing the concentration of anesthetics more a marketing move than it really helps to solve problems of improving the effectiveness of anesthesia. In two cases, manufacturers claimed active substances that were supposed to convince consumers of the best efficacy of their products, namely epinephrine and benzocaine. Laboratory analysis revealed their absence, although in general, the absence of benzocaine can be considered a plus, since the presence of an ether anesthetic increases the risk of an allergic reaction