The United Kingdom has suspended recruitment to malaria drug hydroxychloroquine (HCQ) trials for the treatment or prevention of Covid-19, the country’s Medicines and Healthcare products Regulatory Agency (MHRA) announced on Tuesday.
“This means that no new participants will be recruited to these trials until further data which justifies their continuation have been provided, and any additional safety measures have been implemented,” it said.
This decision follows advice from the Commission on Human Medicines. The commission had met on June 1 and June 5 to review the data for each trial in response to MHRA requests.
The MHRA has made the decision based on various other data and reports reviewing the efficacy of the drug in treating Covid-19 patients. The results of the recovery trial that had shown no beneficial effect of hydroxychloroquine in patients hospitalised with Covid-19 had also been taken into consideration.
Apart from this, a “New England Journal of Medicine publication using hydroxychloroquine as postexposure prophylaxis of Covid-19, concluding that hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection,” was also considered for making the decision to suspend recruitment into new trials.
“We have told those conducting clinical trials using hydroxychloroquine to treat or prevent Covid-19 to suspend recruitment into their trials. Neither hydroxychloroquine nor chloroquine are licensed to treat Covid-19 related symptoms or to prevent infection,” said Dr June Raine, MHRA’s CEO.
However, the MHRA has advised patients taking the drug for other illnesses to continue doing so and to report any suspected side effects from the drug-using the health agency’s Yellow Card site.
“It is important to note that patients taking hydroxychloroquine and chloroquine to treat other health conditions can continue to do so, as advised by their healthcare professional, as the balance of benefits and risks remains favourable in the licensed uses,” Raine said.
The effectiveness of the drug has been under review across the globe with many countries reconsidering the use of HCQ for the treatment of Covid-19 patients.
The US Food and Drug Administration (USFDA), for instance, revoked the emergency use authorisation (EUA) for HCQ on Monday. The agency in a directive had said that hydroxychloroquine and chloroquine were “unlikely” to be effective against Covid-19.
“Additionally, in light of the ongoing serious cardiac adverse events and other potential serious side-effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorised use,” the USFDA had said.