Common Questions
Below are some of the questions answered by the MHRA concerning lipodissolve/Lipostabil(R) for the full version and for more information on lipodissolve visit the MHRA’s website www.mhra.gov.uk
1. What is Lipostabil?
A: Lipostabil is an intravenous preparation of phosphatidycholine
2.Is this product licensed in the UK?
A: No
3.Is this product licensed elsewhere?
A: Yes, Germany, for example
4.What is Lipostabil licensed for in its country of origin?
A: For prevention (prophylaxis) and treatment (therapy) of blood vessel blockages by fat particles (fat embolism)
5.What about cosmetic use for fat reduction?
A: It is not licensed for this use in its country of origin. The product’s safety has therefore not been assessed for this indication. Cosmetic use does not constitute a special (clinical) need under SI 1999/4.
6.Has the product been assessed for safety for cosmetic use?
A: The safety has not been established for cosmetic use. The usual route of administration for cosmetic use is subcutaneous. This is specifically warned against in the manufacturer’s information sheet.
7.Surely, subcutaneous use for cosmetic treatments is safer than IV use for the licensed indication?
A: The product information sheet from the manufacturer specifically states that Lipostabil should not be given subcutaneously (injection under the skin).
8.Why is this product banned by the MHRA?
A: The product is not ‘banned’. The MHRA will, however, object to notifications for importation of Lipostabil for cosmetic purposes. These do not constitute a special (clinical) need, i.e. they are not a medical indication. The product’s safety has not been established for cosmetic use. The usual route of administration for cosmetic use is subcutaneous. This is specifically warned against in the manufacturer’s information sheet.
9.I have seen Lipostabil advertised for fat reduction- what is the situation with this?
A: Unlicensed medicines may not be advertised in the UK and Lipostabil should not be imported for cosmetic purposes. The MHRA will investigate cases where either activity appears to have taken place, and may take regulatory action.
10.How do I obtain cosmetic treatment with Lipostabil?
A: As the MHRA will object to importation of Lipostabil for cosmetic purposes, this treatment should not be available in the UK
11.Why can I not complete my course of cosmetic treatment?
A: Lipostabil is a licensed medicine in its country of origin (Germany) and will have been assessed for safety, quality and efficacy for specific uses (indications) as part of the licensing procedure. The indications for Lipostabil only relate to specific clinical conditions, such as fat embolism. Additionally, it should be noted that the safety of Lipostabil in cosmetic use is not established and would not have been assessed in granting the licence for other indications. The usual route of administration for cosmetic use is subcutaneous. This is specifically warned against in the manufacturer’s information sheet. The MHRA therefore has concerns about the safety of this product in indications not related to those for which it was assessed and licensed in its country of origin.
12. Are there any known adverse reactions to cosmetic treatment with Lipostabil?
A: The MHRA is aware of at least one potential adverse reaction to cosmetic treatment with Lipostabil in the UK.
13.Are there any other safety concerns with Lipostabil?
A: The product is based upon soya bean extracts and also contains benzyl alcohol. There may therefore be allergy or sensitivity issues in some patients.
