|Date:||Friday 24 February 2012|
|Subject:||MHRA warns against harmful herbal remedies sold as slimming and sex aids.|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
People taking unlicensed herbal products for slimming and erectile dysfunction bought online could be endangering their health, says the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Recent tests conducted by the Danish Medicines Agency and the Austrian Agency for Health and Food Safety (AGES PharmMed) provide further examples of herbal products found to contain Prescription Only Medicines (POM), two of which are banned from the UK market.
The slimming products tested were found to contain phenolphthalein and sibutramine. Phenolphthalein is no longer permitted in medicines as it has been associated with a risk of cancer, and sibutramine is also now banned.
Ingredients contained in the erectile dysfunction drugs include tadalafil and sildenafil which like all medicines can have side effects.
Medicines for erectile dysfunction are only available following consultation with a doctor and consumers should always seek medical advice. There are no registered herbal products for erectile dysfunction or approved as sex aids, in the UK.
Some herbal medicines are authorised as aids to slimming; these will have product licences or traditional herbal registrations. Patients can identify registered herbal products by the THR symbol and those with product licences by their PL number.
Head of Herbal Policy Richard Woodfield said, “Consumers should be aware of the risks with unlicensed medicines and especially those available online. Medicines for erectile dysfunction are only available following consultation with a doctor and consumers should always seek medical advice”.
“Some licensed herbal medicines are available as aids to slimming; these will have product licences or traditional herbal registrations. Patients can identify authorised herbal products by the THR symbol or the product licence number.
“The THR scheme has been implemented to ensure patients can buy herbal products that they know have met quality and safety standards.
“If people think they have suffered a side effect to an unlicensed herbal medicine, they can report it to us via our Yellow Card Scheme”.
Notes to Editor1. The following herbal slimming products have been issued with safety alerts: Expelling Grease Slimming Abdomen, V12 Fruit Slimming, 100% Natural Weight Loss Coffee, Leisure 18.,Slimming Orange Juice, Fashion Slimming Milk Shake, Langli, Ya Buk, Fruit and vegetables lose weight and Paiyouji Plus Tea. Please see link to the Herbal safety alert.
2. The following herbal erectile dysfunction products have been issued with a safety alert: AH Free/Reflexit, Stree Overlord, Man King, VigRX, Maxman, Maxman III, Viriya, Imbiza for Men. Please see link to the Herbal safety alert
3. Sibutramine was a Prescription Only Medicine used to treat obesity which was withdrawn in January 2010. The European Medicines Agency (EMA) completed a review due to concerns that use of the drug increased the risk of heart attacks and strokes. The EMA review concluded that the cardiovascular risks outweighed the benefits of use. Sibutramine was then withdrawn and its licence suspended across Europe.
4. Phenolphthalein has previously been used as an ingredient for laxative products. It is no longer used as there are concerns that it may be a cancer causing agent.
5. The Traditional Herbal Registration (THR) symbol is a type of trade mark which indicates that a herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) Scheme and meets the required standards relating to its quality, safety, evidence of traditional use as well as other criteria.
6. Herbal remedies should be used with the same caution and care as any other medicines as their use will have an effect on the body. While many herbal remedies are reasonably safe, it is important to remember that just because it contains natural ingredients and extracts this doesn’t guarantee it is safe. You should always consult with a pharmacist or doctor to make sure that a herbal remedy is suitable for you to take and will not interact with any other medicines you may be taking. Stay safe when using herbal remedies, follow us on Twitter @staysafeherbals (external link).
7. For over 40 years, the Yellow Card Scheme has been the cornerstone of medicines safety monitoring in the UK. Since the Yellow Card scheme was set up, over 600,000 reports of suspected side effects (known as adverse drug reactions) have been completed. The Yellow Card Scheme was set up in 1964 following the Thalidomide tragedy to provide a system for early detection of emerging drug safety hazards, and the routine monitoring for all medicines in clinical use. Reports of suspected side effects are also received from pharmaceutical companies, who have a legal obligation to report suspected serious side effects to the MHRA.
8. 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. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.