One person has died and another five are in a serious condition after taking part in a French clinical drugs trial
The Guardian has reported that the six patients had been in good health until taking the oral medication at a private laboratory in Rennes.
The oral trial was conducted by Biotrial, a French-based company which has carried out thousands of trials since it was set up in 1989 according to the BBC.
The phase one clinical trial, testing safety and side effects, has now been suspended and the firm is recalling volunteers but it is unknown how many people were involved.
The Guardian said that a source close to the case told AFP that the drug was a painkiller containing cannabinoids, an active ingredient found in cannabis plants.
France’s medicines agency, Agence Nationale de Sécurité du Médicament (ANSM) has launched an investigation into the laboratory.
The French health minister, Marisol Touraine is travelling to the clinic in Rennes where she said to the BBC she pledges to, “get to the bottom... of this tragic accident."
A Medicines and Healthcare product Regulatory Agency (MHRA) spokesperson said: “There is no clinical trial taking place in the UK with this product nor has it been used in a clinical trial in the UK in the past.
“Clinical trials in general have an excellent safety record and hundreds of phase one clinical trials are authorised each year by MHRA.
“Before any trial of a new medicine begins in humans, the product will have undergone extensive pre-clinical testing, both in the laboratory and in animals as appropriate.
“Safeguards for clinical trials are well-established and regulations are in place, which specifies how clinical trials should be conducted.”
