A group of researchers are calling for additional caution when it comes to testing new drugs in human trials after the deadly case in France where one volunteer died and five others became critically ill due to an experimental painkiller.
An editorial was recently published in the British Journal of Clinical Pharmacology reviewing this incident.
Portuguese pharmaceutical company Bial held a Phase 1 trial in early January. The drug being tested was named BIA 10-2474, a fatty acid amide hydrolase (FAAH) inhibitor that targets the body’s endocannabinoid system.
The scientists had found that the drug candidate had went through safety reviews, but did not raise any alarms in terms of safety because it had already “been tested in non-human primates and medicines with a similar mode of action had also been given previously to people without ill effect,” according to Reuters.
Investigators running the trial felt those factors indicated they didn’t need to perform a cautious approach where the first dose of the inhibitor was given to one participant to gauge the effects before administering the medication to other participants.
Plus, a report in Nature back in January had noted previous clinical trials focusing on FAAH inhibitors had shown these compounds were safe, but most of these experiments demonstrated the drugs are ineffective as potential painkillers.
However, a committee appointed by the French National Agency for Medicines and Health Products Safety determined the administered dosage was 40 times above the necessary threshold needed to block FAAH causing the drug to attack other enzymes in the brain, writes The New Scientist.
Ultimately, the authors of the editorial called for tougher risk assessments and recurrent dosing schedules to prevent the chance of this happening again.
Filed Under: Drug Discovery