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Adverse drug reactions

Phase I trial volunteer dies as five others are hospitalised

Six volunteers were given an experimental pain drug produced by Bial. On 15 January 2016 the patients began to show severe symptoms and were rushed to Rennes hospital (pictured), with one patient initially left as brain dead and who died 2 days later

Source: Matthieu Pattier / SIPA / Rex Shutterstock

Five patients remain in a stable condition in the University Hospital in Rennes, France, after experiencing a severe adverse reaction to an experimental drug as part of a phase I trial

One person has died and five more have been hospitalised after taking part in a phase I clinical trial in France.

The six volunteers were given an experimental pain drug produced by the Portuguese pharmaceutical company Bial. On 15 January 2016, the company reported that the patients had begun to experience severe symptoms. One patient was declared brain dead and later died on 17 January 2016. The five other patients remain in a stable condition in the University Hospital in Rennes, France, according to a statement released by the hospital.

The drug in question has been part of an ongoing phase I trial since June 2015 and had been administered to 108 trial participants prior to the six affected by severe adverse events. Bial says that all of the previous trial participants were given the drug “without any moderate or serious adverse reaction”.

A company called Biotrial was responsible for conducting the clinical trial and issued a statement saying that “serious adverse events related to the test drug have occurred in some subjects at our [clinical pharmacology unit]”. Bial says it is trying to determine what has happened.

Following the hospitalisation of the patients, 84 previous participants were contacted for urgent examination. Ten came forward, none of whom show any of the “clinical abnormalities” experienced by the six affected patients, says the hospital.

Both Bial and Biotrial say that all international guidelines and regulations have been followed during the development of the molecule, which inhibits fatty acid amide hydrolase (FAAH). 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200508

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Supplementary images

  • Six volunteers were given an experimental drug produced by Bial. On 15 January 2016 Bial reported patients had shown severe symptoms and were rushed to Rennes hospital (pictured), with one patient initially left as brain dead and who died 2 days later
  • Rennes Hospital in France where six victims of the French clinical trial were hospitalised, once of which died shortly after

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