EU Drug Regulator Confirms That Chloroquine, Hydroxychloroquine Can Have Adverse Psychiatric Effects

A photo illustration of the anti-malarial drug hydroxychloroquine, which was once touted as a COVID-19 treatment.
Buda Mendes / Getty Images

On Friday, the safety committee of the European Union’s decentralized drug regulator — the European Medicines Agency (EMA) — recognized a link between the use of chloroquine and a related compound, hydroxychloroquine, and side effects including psychiatric problems and suicidal behavior. The drugs, which have been used around the globe to treat malaria, were previously championed by President Donald Trump as treatments for COVID-19 before being deemed ineffective.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) further suggested that the product information of all medicines containing the compounds be updated to inform users of their potentially dangerous side effects.

“The PRAC recommends updating the product information for these medicines to provide better information to healthcare professionals and patients on the risk of suicidal behavior and psychiatric disorders,” stated the report.

Per the EMA release, a review of the compounds was initiated in May when a Spanish medical agency informed the outfit of six cases of psychiatric disorders that seemingly stemmed from COVID-19 patients receiving higher than authorized doses of hydroxychloroquine.

The study confirmed that disorders have occurred in patients both with and without prior mental health issues and that they were of a serious nature in some instances. Using available data, it was assessed that those treated with hydroxychloroquine could experience adverse effects in the first month. However, a clear determination has not been made regarding chloroquine.

During the earlier stages of the COVID-19 pandemic, the medications received significant press when Trump tweeted that hydroxychloroquine taken in tandem with the antibiotic azithromycin had “a real chance to be one of the biggest game-changers in the history of medicine.”

Shortly thereafter, an emergency use authorization was issued by the Food and Drug Administration (FDA) in the U.S. However, it was later revoked in June. In Europe, the EMA has repeatedly warned against the medication’s use with regard to the ongoing pandemic.

Throughout the year, a significant number of clinical studies have concluded that the anti-malarial medication yields no benefit as a treatment for the novel coronavirus. Moreover, multiple studies — including a May trial done by the World Health Organization (WHO) — linked the drug to a risk of heart arrhythmia, other cardiovascular problems and even an increased incidence of death.

Nevertheless, the president and members of his family and administration continued to espouse its use in the battle against the virus.

Donald Trump Jr speaks at CPAC 2020.
  Samuel Corum / Getty Images

In July, Twitter suspended the account of Donald Trump Jr. for several hours for spreading coronavirus misinformation after he posted a video about the medication.