It issued a warning about a product called ‘Herbal Flos Lonicerae (Herbal Xenicol) Natural Weight Loss Formula’ at the start of February after adverse events including palpitations, gastritis, abdominal pain and insomnia were reported, but did not name the contaminant in question due to ongoing testing.
Those tests have revealed the presence of sibutramine at levels twice that at which it was formerly approved in the EU before having its medicinal license rescinded in January 2010 after the European Medicines Agency linked it to increased risk of high blood pressure, seizures, heart attack or stroke.
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.
Sibutramine
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) has issued many consumer warnings against sibutramine-containing weight loss and erectile dysfunction products.