The Medicines and Healthcare products Regulatory Agency (MHRA) is warning consumers of the dangers of buying medicines from unregulated websites after the discovery in the United States of counterfeit Alli, a weight loss drug.
The Food and Drug Administration (FDA) in the US has been working with pharmaceutical manufacturer GlaxoSmithKline (GSK) following the report of counterfeit Alli, which although has not been found in the United Kingdom, is still potentially available to UK customers via the internet.
Alli is available over the counter (OTC) in the UK with the genuine product containing the active ingredient orlistat. Laboratory testing of the suspected counterfeit product, 60mg Alli capsules (120 capsule refill kit), revealed it contained sibutramine instead of orlistat. The licence for sibutramine was recommended for suspension across Europe last week by the European Medicines Agency (EMA) following evidence to suggest an increased risk of non-fatal heart attacks and strokes.
MHRA Head of Enforcement Mick Deats said purchasing medicines from unregulated internet pharmacies is a risk not worth taking. "The trend of self-diagnosing and self-prescribing is potentially dangerous, but unless the website has a physical address clearly displayed, and the green cross logo of the Royal Pharmaceutical Society of Great Britain (RPSGB) then the likelihood of obtaining a counterfeit product is greatly increased.
"Buying weight loss medication from unregulated websites is a dangerous way to slim down. You don't know what you're taking and your condition is not being monitored by a healthcare professional. It's just not worth taking that type of risk."
The counterfeit Alli can be distinguished from the genuine product by the following means:
1. The absence of a Lot code on the end flap of the outer packaging
2. A plain foil inner safety seal under the plastic cap, without any printed words – the authentic product seal is marked ‘sealed for your protection'
3. The counterfeit capsules contain white powder instead of small white pellets.
4. In the UK, the legitimate product is not available in packs of 120, only in smaller packs of 42 and 84. Every authentic capsule is clearly marked ‘Alli' in the licensed UK product and ‘Orlistat' in the legitimate US product. Counterfeit capsules are not marked at all.
Consumers are advised to consult their pharmacist or healthcare professional if they have any concerns or alternatively to report any suspected counterfeit Alli, together with the details of the website where it was purchased, to the MHRA Counterfeit Hotline on 020 7084 2701 or counterfeit@mhra.gsi.gov.uk
