Doctor Prosecuted For Advertising And Selling An Unlicensed Medicine - 'Fat Jab', UK

Main Category: Medical Malpractice / Litigation
Also Included In: Cosmetic Medicine / Plastic Surgery
Article Date: 28 Apr 2008 - 4:00 PDT

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The Medicines and Healthcare products Regulatory Agency (MHRA) successfully prosecuted a man from Nottingham at the City of London Magistrates Court on Wednesday 23 April 2008 for illegally possessing with intention to sell and advertising the unlicensed drug, Lipostabil®, for cosmetic purposes.

Dr. Dinesh Maini, a GP based at the Lenton Surgery, 266 Derby Road, Nottingham, NG7 1PR, pleaded guilty to three charges and was ordered to pay over £10,000 in costs and fines.

In 2005, Dr. Maini advertised Lipostabil® and referred to the drug as 'Fat Jab' in an advert placed in the Nottingham Evening Post. He was contacted by the MHRA to stop advertising the unlicensed medicine. However, he continued to advertise on a website called http://www.nottinghamlaserclinic.com . The MHRA subsequently visited the Lenton surgery and seized 187 full packs and 3 incomplete packs of Lipostabil®.

Mick Deats Head of Enforcement and Intelligence of the MHRA said "This successful prosecution highlights the robust action the MHRA takes against those who illegally advertise, sell and administer unlicensed medicines for cosmetic purposes. Consumers should be aware that Lipostabil® is unlicensed in the UK, and the safety of this product for cosmetic use has not been established."

Notes

Lipostabil® is not licensed in the UK. Lipostabil® is licensed as an intravenous medicine in Germany, its country of origin, for the prevention and treatment of blood vessel blockages by fat particles (fat embolism). It is not approved or licensed for cosmetic use. Product safety has not been established for subcutaneous use for cosmetic purposes. Consumers should be aware of this should they be offered the product.

The Medicines and Healthcare products Regulatory Agency (MHRA) has received reports of potential adverse reactions to cosmetic treatment with Lipostabil®. Some patients may experience allergic reactions or sensitivity issues to the product. The usual route of administration for cosmetic surgery is subcutaneous (injection under the skin) and this is warned against in the manufacturer's information sheet which specifically states that Lipostabil® should not be given subcutaneously.

However, it may be imported into the UK by doctors for clinical use for the prevention and treatment of fat embolism subject to compliance with the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations (SI 1999/4). This allows for importation from elsewhere in the EU by holders of Wholesale Dealers Licences, or from outside of the EU by holders of Wholesale Dealers Import Licences. When ordering, proof must be available from the doctor to demonstrate the existence of a special clinical need for the patient. The MHRA must be consulted about the import by the wholesaler using the notification procedure set out in SI 1999/4. The use of Lipostabil® for cosmetic purposes does not constitute a special clinical need.

The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem.

http://www.mhra.gov.uk