Date of prep: December 2020
Prescribing information and
adverse events reporting
For healthcare professionals only
The Medicines and Healthcare products Regulatory Agency (MHRA) has instructed UK clinical trialists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of further participants.
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.
This decision follows advice from the Commission on Human Medicines, which met on 1 and 5 June 2020 and reviewed the data that had been submitted for each trial in response to MHRA requests.
The MHRA said they followed the emerging concerns about the use of hydroxychloroquine in COVID-19 and took into consideration the results from two different trials, including the UK’s RECOVERY trial which has provided convincing evidence of no meaningful mortality benefit in hospitalised patients with COVID-19.
Dr June Raine, MHRA’s CEO, said:
“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.
“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.”
This article is being shared under the Open Government Copyright licence.
Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.