The Pharmaceutical Journal
Vol 270 No 7251 p740
31 May 2003

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Unlicensed ephedra under review in UK

The Medicines and Healthcare products Regulatory Agency is reviewing the use of Ephedra species in unlicensed herbal remedies.

It is taking this step in the light of US Food and Drug Administration plans to restrict the permitted dose and duration of use of ephedra in supplements and to introduce warning labelling. In Canada, ephedra products with doses equivalent to 8mg ephedrine and daily doses of 32mg ephedrine have been withdrawn, as have unlicensed ephedra products combined with other stimulants.

Current controls over ephedra in the United Kingdom restrict doses of more than 600mg herb (equivalent to 12mg ephedrine alkaloids) and daily doses of more than 1,800mg herb to pharmacy supply. Below these doses, ephedra products can only be supplied following a one-to-one consultation with a herbalist.

The MHRA wants more information on the nature and extent of usage of ephedra in unlicensed herbal remedies and details of the information and advice given to patients prescribed ephedra by herbalists. It also wants to collect views on the current regulatory position. Information can be sent to Alexandra Williamson, 16-131 Market Towers, 1 Nine Elms Lane, London SW8 5NQ (tel 020 7273 0970, e-mail alex.williamson@MHRA.gsi.gov.uk) until 20 June.