• Aristolochic acid (To be replaced by Stephania tetrandra and Inula helenium)

• Dietary supplement
  ( Adulterated with estazolam)

• Herbal medicines
  (New packaging to combat misinformation)

• Menze Qianweishu slimming herbs capsule
  (Found to contain sibutramine)

• Qing zhisan tain shou,
  Li Da Dai Dai Hua, Meizitang (Presence of sibutramine)

• Severe liver reactions with Kava (Piper methysticum) (Switzerland)

• VIGA/VIGA FOR WOMEN (Presence of sildenafil)

• Yohimbine-containing products (Dangerous in high-risk groups)

Aristolochic acid
To be replaced by Stephania tetrandra and Inula helenium  

People's Republic of China. China's State FDA (SFDA) has banned two commonly used herbs containing aristolochic acid, a toxin reported to be linked to kidney failure and cancer. Manufacturers have been directed to replace Aristolochia fangchi and Aristolochia debilis with Stephania tetrandra and Inula helenium respectively, in their traditional medicine formulations by 30 September. The Provincial Drug Bureaux has been instructed to carry out inspections to ensure compliance with the ban by 31 October. Medicines found to contain either Aristolochia fangchi or Aristolochia debilis after 30 September will be treated as fake under Chinese law. By a previous order, special restrictions were imposed on four other potentially harmful aristolochic acid-containing herbs (Fructus Aristolochiae, Aristolochia mollissima Hance, Herba Aristolochiae and Aristolochia tuberose) in China; there was no outright ban on these products. Several countries withdrew aristolochic acid­-containing preparations in 1981 following the demonstration of a carcinogenic potential in a three-month toxicity study in rats (see UN Consolidated List of Products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved by governments, Eighth Issue, Pharmaceuticals, available at http://www.un.org/esa/coordination
/ecosoc/Consolidated.List.of.
Products.final.pdf). 

More recently, in 2001, severe adverse events among users of herbal and dietary preparations containing aristolochic acid have led to bans or consumer warnings in different parts of the world (see WHO's Pharmaceuticals: restrictions in use and availability, April 2003, available at http://www.who.int/medicines/
library/docseng from a to z.sht ml#p. 

Reference:
Scrip World Pharmaceutical News No. 2985, 8 September 2004. Available on the Internet at www.scrippharma.com

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Canada. Canadian consumers have been warned by Health Canada not to use Salt Spring Herbals Sleep Well Dietary Supplement, as a sample has been found to contain estazolam. Health Canada advises that although there have been no reports of adverse reactions suspected of being associated with the supplement, estazolam is a sedative that can be habit­forming after only a few months of use, and serious adverse effects associated with the drug include memory loss, hallucinations, depression and confusion; other common adverse effects include dizziness and drowsiness. The agency also warns that people with a benzodiazepine allergy, or who have myasthenia gravis, sleep apnoea, are pregnant or elderly or have a history of substance abuse, should not use estazolam. Health Canada says that consumers taking the supplement should talk to a health-care professional before they stop using it, as withdrawal symptoms are possible. Although the product is not authorized for sale in Canada, the agency advises that the product has been found on the Canadian market. The Canadian distributor has initiated a recall.  

Reference:
Advisories, Warnings & Recalls. Health Canada, 30 August 2006 (http://www.hc-sc.gc.ca).

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UK. The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that any approved herbal product will now have a Product Licence number or Traditional Herbal Registration number on its packaging.

The incidence of severe hepatic complications can be estimated at around 1: 35,000 and 1: 175,000 patient months in Switzerland and on an international level respectively. CYP2D6 deficiency was shown in two patients, possibly a predisposing factor. Review of the international data reveals 9 reports including the 4 Swiss reports. 8 of these reports are with the acetone extract. Taking into account the benefits (versus risks) and the available alternatives, the acetone kava root extract was withdrawn in April 2001 in Switzerland. The alcohol extract as well as a synthetic preparation containing d-/l-Kavaine, with a seemingly much lower incidence of severe liver reactions, have remained on the market. However the kava ethanol extracts have been moved from OTC to 'pharmacy only' status in September 2001 and put under special monitoring.  

Discussion: The mechanism of the reactions to kava extract is unclear and may be allergic or toxic in nature. Fiji has reported that Kava is widely used in its natural form but has not experienced reports of hepatic disorder, although concomitant alcohol abuse can make signal identification difficult. These cases also highlight some shortcomings of non-drug causes of hepatic ADR reports.

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VIGA/VIGA FOR WOMEN
Presence of sildenafil  

USA. Health Nutrition (RMA Laboratories), under advice from the US FDA is warning consumers not to purchase or consume the product known as VIGA or VIGA FOR WOMEN. These products are sold as dietary supplements, without a medical prescription and have been found to contain sildenafil.  Sildenafil is a prescription drug and may have serious health risks if used without medical supervision, particularly if the users are also on concurrent nitrate therapy. The interaction between nitrates and sildenafil can result in profound and life-­threatening lowering of blood pressure. The use of nitrates is therefore an absolute contraindication for sildenafil users. Consumers who have purchased VIGA or VIGA FOR WOMEN tablets are urged to immediately discontinue their use and to return them to their place of purchase or directly to Health Nutrition (RMA Laboratories). 

Reference:
Recall-Firm Press Release from Health Nutrition, 24 Jun 2003. Available from URL: http://www.fda.gov

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Yohimbine­containing products
Dangerous in high-risk groups  

Canada. Health Canada has issued an Advisory, warning consumers not to use unapproved yohimbine- or yohimbine-containing bark products, including Strauss Energy SIX* capsules manufactured by Strauss Herb Company, because yohimbine may pose serious health risks for people with underlying risk factors such as hypertension or heart, liver or kidney disorders. Health Canada says that the most consistently reported yohimbine-associated adverse effects (AEs) are anxiety and increased urinary frequency; other AEs include dizziness, GI disorders, diaphoresis, insomnia, headache, palpitations, severe hypertension and tremors. Health Canada advises consumers who have used the products, and have health concerns, to contact their physician, and that yohimbine should not be used in pregnant or nursing women, or children.  

(* Not authorized for sale in Canada but promoted to increase energy levels, build body mass and restore or enhance sexual performance).  

Reference:
Advisory. Health Canada, 10 April 2006 (http://www.hc-sc.gc.ca)