Acute poisoning from Coleus forskohlii containing products, letter to herbalists, UK

Main Category: Complementary Medicine / Alternative Medicine
Article Date: 02 Jun 2005 - 9:00 PDT

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This is a letter to herbal interest groups from the Senior Herbal Policy Manager of the MHRA (UK) -

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has received information from the Italian Regulatory Authority, that certain products containing Coleus forskohlii have been associated with four cases of acute atropine like poisoning (agitation, confusion, hallucination, tachycardia, mydriasis and past amnesia) following their ingestion.

Two additional adverse drug reaction (ADR) reports of tremor, asthenia, visual disturbance and confusion have also been related to the use of Coleus forskohlli containing products in Italy.

The Italian authorities suspect a possible batch contamination. Whilst it has not been confirmed, it is possible that Coleus forskohlli may have been substituted or adulterated with a member of the Solanaceae family. This is a family which includes a number of poisonous and pychoactive plants, and includes Atropa Belladonna (Deadly Nightshade). Many members of the family contain tropane alkaloids such as atropine.

A list of specific products associated with the cases of acute poisoning is provided below.

Although the MHRA has not received any ADR reports indicative of atropine like poisoning associated with Coleus forskohlii in the UK, it is possible these products may have found their way onto UK market and potentially pose a risk to public health. If you or any of your members have stocks of any of these products please quarantine them, cease distribution and notify the MHRA. It is unclear at this stage whether only the named products are affected or whether contamination of a harvest of Coleus may have occurred at source. An update will be provided when further information becomes available.

I am grateful for your assistance in this matter.

Dr Alison Daykin

Senior Herbal Policy Manager

Product - Coleus Forskohlii 20 %
Manufacturer/Exporter - Indoworld Prating Coorporation (India), Galerno SRL, Alchem International (India), EPO SRL

Product - Coleus Forskohlii 20 %
Manufacturer/Exporter - EPO SRL, Galeno SRL

Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
UK
http://medicines.mhra.gov.uk

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