Health authorities in France and Spain have suspended the sale of French supplements manufacturer Arkopharma's Exolise green tea extract diet aid after reports of 13 individual adverse reactions since 1999.
While noting that the reactions were extremely rare (one in 100,000—less than strawberry or nut allergies) and the effects were not severe, except one case requiring hepatic transplantation, the French and Spanish authorities went ahead with the ban. Arkopharma also agreed to withdraw Exolise from other countries where it is available.
In a statement, the French agency noted the decision relates only to "a speciality whose mode of preparation is particular (extracted strong hydro-alcoholic from sheets of green tea). It does not apply to the other drugs made up of green tea (extracted weak hydro-alcoholic, aqueous extract and powder of sheet) authorized in France. It does not call in question the traditional use of green tea in phytotherapy or in food."
An Arkopharma spokesperson said the company would be modifying the extraction process and expected the product to be back on sale by autumn.
Swiss-based Emil Flachsmann, which used to supply the green tea extract for Exolise until 2001 when Arkopharma developed its own ingredient, has withdrawn its green tea extract voluntarily, while vowing to fight the decision.
"It is probably a bit of a hyper reaction by the health authorities," said business development officer Stephan Vautravers. "The evidence is not very conclusive as the status of the patients is not very clear. They were taking other medicines at the same time."
He added, "We don't consider that our extract is dangerous—we have used a common extraction process in this ingredient. But we have decided to comply with the French health authorities' concerns over this until the situation is resolved."
Flachsmann is conducting research into the adverse reactions and will present its case to the French authorities before the end of the year.