The EU's medical agency recommends that product information for hydroxychloroquine mention possible psychiatric risks.
Health officials are unsure what to do with stockpiles of the drug and the related chloroquine after the FDA declared them risky and likely ineffective to treat coronavirus.
Hydroxychloroquine and a similar drug, chloroquine, have been the subject of much debate since Trump started promoting them in March.
President Donald Trump says he’s been taking hydroxychloroquine, the anti-malarial drug his administration has touted as a potential treatment for the coronavirus pandemic. The Food and Drug Administration has warned against its use in COVID-19 cases except in formal studies, citing serious heart risk.
Many health experts say there is no proof that hydroxychloroquine is safe and effective for treating COVID-19.
The FDA said it was aware of increased use of the medicines hydroxychloroquine and chloroquine through outpatient prescriptions.
"We don’t really know if it’s helpful in this case," the actor said of her treatment with the malaria drug chloroquine.
In the rush to find a treatment for the coronavirus, shortages of chloroquine mean people with various health conditions are missing out on medicine they need.
The man and his wife drank a fish tank cleaner containing chloroquine, which the president has touted as a treatment despite a lack of scientific evidence.
Tucker Carlson, Glenn Beck and more have given a giant platform to a sketchy paper touting chloroquine.