The ANSM has withdrawn from the market 2 anti-aging skincare products from the Promicea laboratory. They contain drugs that can have side effects.
According to the advertisements, the border is sometimes thin between cosmetic products and drugs. But a French laboratory happily crossed it. The National Medicines Safety Agency (ANSM) has just withdraw from the market two “anti-aging serums” sold by the Promicea laboratory.
The products, sold as cosmetics, in fact meet the definition of the drug. But they did not follow the usual route, which allows to obtain a marketing authorization (AMM).
An obvious violation
Neostem serum and Neostem pocket lift were previously sold on the Promicea site, as well as in some French pharmacies, for a sum of 69 to 89 euros. A high cost for a precise process. “Recent studies have shown a causal relationship between telomere dysfunction and the overproduction of progerin”, explains the laboratory. on his site.
Progerin is a protein involved in particular in the premature aging of certain patients with a rare disease, Hutchinson-Wilford syndrome. Promicea is therefore betting on the production of this protein. Its serums combine sodium alendronate with sodium pravastatin to improve cell renewal. On paper, the approach is promising.
With one detail: the two active ingredients mentioned are drugs. And the lab has not received any official authorization to use them. The products are therefore in violation of the applicable regulations.
Many side effects
This non-compliance with the rules set by the ANSM is already worth a suspension in itself; but the matter does not end there. By selling its serums as cosmetic products, Promicea has not carried out an assessment of the benefit / risk ratio. However, pravastatin and sodium alendronate are both drugs, indicated respectively in excess cholesterol and osteoporosis.
But they are especially registered on the list of poisonous substances. This means that the side effects can pose a risk to human health. The laboratory is aware of this, since it does not recommend serums for pregnant and breastfeeding women. And the side effects associated with the active ingredients are wide: gastrointestinal disorders, skin reactions, immune system disorders… The list goes on.
End of production
A key element is added: the ophthalmological toxicity of sodium alendronate is known. And one of the two serums is for the eyes. Not to mention that pravastatin interacts with two other drugs, fibrates – a lipid lowering agent – and ciclosporin – an anti-rejection treatment. In short, “the pharmacological properties (of the serums are) incompatible with the status of cosmetic product”, slices the ANSM.
Promicea is therefore forced to withdraw the products from the market “until they are brought into compliance with the drug regulations applicable to them”. Nor will he be able to distribute them for free or manufacture them until he has fallen into line. But the laboratory is rather optimistic on its site, since it specifies that the serums will be “soon available”.
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