The Medicines Control Agency has now issued its consultation letter (MLX254) proposing a ban on unlicensed medicinal products containing aristolochia (PJ, July 31, p150). The aim is to make permanent the temporary ban introduced on July 28 because of a serious risk to health.
As well as proposing a ban on the import, sale or supply of preparations containing plants of the genus Aristolochia, the MCA is also considering banning other herbal ingredients that might be confused or contaminated with aristolochia. It says that kidney damage caused by aristolochia has arisen from confusion between Aristolochia fangchi (Pin Yin name guang fangji) and Stephania tetrandra (Pin Yin name han fangji). Another problem is the use of the Pin Yin name mu yong for a range of supposedly interchangeable herbs, including Aristolochia manshuriensis, Clematis armandii, C montana, Akebia quinata and A trifoliata.
The consultation letter asks for views on whether the ban should extend to all preparations described as containing fangji or mu tong or any of the species named above. It also asks whether the ban should be an outright one or should provide an exemption where the person placing a product on the market has exercised due diligence to ensure that the product did not contain aristolochia.
Aristolochia has been a prescription-only medicine since 1997, but is exempt from POM control when used in herbal or homoeopathic medicine.