Coleus Forskohlii and Forskolin Mechanism of action.

Coleus Forskohlii Safety and Toxicity.

Coleus Forskohlii Extract CAS 66575-29-9 66428-89-5 photo picture image Acute poisoning from Coleus forskohlii containing products, letter to herbalists, UK:Dr Alison Daykin,Senior Herbal Policy Manager Medicines and Healthcare products Regulatory Agency,Market Towers,1 Nine Elms Lane,London SW8 5NQ,UK,http://medicines.mhra.gov.uk.

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.

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

Acute Oral Toxicity (LD50):

Acute oral toxicity of Coleus forskohlii 10% was determined in Sprague Dawley rats. The test substance suspended in water was administered by oral route and the experimental animals were observed for 14 days for product-related symptoms. The test substance did not produce any signs of intoxication after dosing and all animals survived the study period of 14 days. The LD 50 value of the product in rats by oral route was found to be greater than 2000mg/kg body weight.

Sub-chronic Toxicity:

Sub-chronic oral toxicity study was designed and conducted to Determine the toxicity profile of Forslean? when administered daily for 28 days in Sprague Dawley rats. Forslean? suspended in 0.1% aqueous CMC was administered to animals at varied doses. Their body weight and biochemistry were monitored during the period of experimentation. Based on the findings the no observed effect level (NOEL) of Forslean? in these experimental animals over a period of 28 days was found to be 100 mg/kg for male and female animals.

Sub-Acute Oral Toxicity:

Sub-acute oral toxicity study was designed and conducted to determine the toxicity profile of Forslean ? when administered daily for 28 days in Sprague Dawley rats. Test material suspended in 0.1% aqueous CMC was administered to the animals at various dose levels. Hematological and biochemical analyses were carried out at the end of experimentation. All the animals survived the experimentation period and did not present any signs of intoxication. No abnormalities were detected. Based on these findings it was concluded that the no observed effect level (NOEL) of this product administered to rats orally over a period of 28 days was found to be 1000 mg/kg body weight for both male and female animals.