Newsletters - May 2005

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Italian Regulatory Authority and the Medicines and Healthcare products

Regulatory Agency (U.K), have been alerting global regulatory agencies 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 forskohlii containing products in Italy.

The products in question are Coleus forskohlii 20% supplied by Indoworld Prating Corporation (India), GALENO SRL, EPO SRL And Alchem International Ltd (India) and Coleus forskohliii 10% supplied by GALENO SRL, EPO SRL. 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 psychoactive plants, and includes Atropa belladonna (Deadly Nightshade). Many members of the family contain tropane alkaloids such as atropine. These reports accentuate the importance of stringent quality control in sourcing, processing, storage and distribution of herbal products.

The branded ingredient ForsLean® a standardized extract from Coleus forskohlii roots supplied by Sabinsa Corporation, undergoes stringent testing at every stage, and has clinically proven safety and efficacy. Recently, an independent toxicological review by CANTOX Health Sciences International, further established the safety of ForsLean®.

 

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