The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued warnings against two pharmaceutical-laced, unlicensed herbal medicines.
It created the alert about Payouji tea and Pai You Guo Slim Capsules after it determined the supplements were spiked with, “an undeclared pharmaceutical active ingredient, sibutramine”.
Sibutramine is banned in the European Union as it has been linked to serious side effects such as serious side-effects such as high blood pressure, seizures, heart attack or stroke.
It has also been shown to be contraindicated with prescription medication.
“People need to be aware that Payouji tea and Pai You Guo Slim Capsules are unlicensed herbal medicines and therefore have not met assured standards,” said MHRA head of herbal policy, Richard Woodfield.
The agency urged anyone taking the supplements to cease doing so immediately and said anyone suffering from side-effects could immediately report them via its Yellow Card Scheme at http://yellowcard.mhra.gov.uk/ .
It also said licensed products carried the Traditional Herbal Registration (THR) mark on-label under the 2004 Traditional Herbal Medicinal Products Directive (THMPD). The THMPD is due to take full effect in March 31, 2011, when in theory, all herbal products seeking to make medicinal claims will have to be registered across the 27-member state bloc.
Until October 1, 2010, there have been 161 THR applications in the UK, of which 75 have been granted. None have as yet been rejected.
Except Germany, there have been few other applications in other EU member states.
Sibutramine, along with sildenafil, glibenclamide, tadalafil, vardenafil or their analogues, or lignocaine, is commonly found illegally in botanical products claiming to aid weight loss or erectile dysfunction. Singapore, the US, Canada, Hong Kong, Australia and the Netherlands have recalled herbal viagra products recently.
The Singapore Health Sciences Authority issued recalls on several products in 2008 after its medical products agency received 240 adverse events including ten deaths related to products tainted with toxic doses of glibenclamide.
The MHRA in April, 2009, issued a recall when sibutramine, as well as tadalafil, were found in a product called Jia Yi Jian that was marketed as being “100% herbal”, yet each tablet contained 68.1mg of sibutramine and 50.06mg of tadalafil when respective levels of only 15mg and 20mg are permitted in the UK.
The US Food and Drug Administration (FDA) this month issued a consumer warning against bitter orange-based weight loss supplements due to the unauthorised presence of sibutramine.