EMA limits use of malaria drugs for COVID-19 as FDA reports shortages

Regulatory NewsRegulatory News | 01 April 2020 |  By 

Two drugs primarily used to treat malaria, chloroquine and hydroxychloroquine, should not be used to treat coronavirus disease (COVID-19) outside of clinical trials or emergency use programs, the European Medicines Agency (EMA) said Wednesday.
The agency said there is currently no evidence for the drugs’ efficacy in treating COVID-19 and warns that both drugs can have serious side effects.
“They must not be used without a prescription and without supervision by a doctor; prescriptions should not be given outside their authorised uses except in the setting of a clinical trial or nationally agreed protocols,” EMA said.
While evidence to support the use of the two drugs to treat or prevent COVID-19 is scant, the drugs have already been deployed to treat COVID-19 in some countries, like the US, and several small studies have been conducted examining hydroxychloroquine, in some cases combined with the antibiotic azithromycin, with varying results.
“Large clinical trials are under way to generate the robust data needed to establish the efficacy and safety of chloroquine and hydroxychloroquine in the treatment of COVID-19. EMA welcomes these trials, which will enable authorities to give reliable advice based on solid evidence to healthcare professionals and patients,” the agency said.
EMA also noted that both medicines are “vital” for patients with other diseases, including lupus and rheumatoid arthritis.
The drugs have also been heavily promoted by US President Donald Trump, who has called them a potential “game changer” in the fight to treat COVID-19. Despite limited evidence of their efficacy, the drugs were supplied to states via an emergency use authorization (EUA) from the US Food and Drug Administration earlier this week.
Shortly after FDA issued the EUA, the agency announced shortages of both chloroquine and hydroxychloroquine from multiple manufacturers.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy