Information about the risks of chloroquine and hydroxychloroquine came from the Spanish Agency for the Control of Medicines and Medical Products (AEMPS), the EMA said in a statement. There have been six cases of mental disorders in patients who took hydroxychloroquine at higher than approved doses to treat COVID-19.
Re-examination of the data confirmed episodes of mental disorders. The regulator clarifies that in some cases they can be serious, both in patients with and without previous mental problems. When taking hydroxychloroquine, side effects may appear in the first month of treatment; this period has not been established for chloroquine.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended updating information on these drugs. Patients who develop mental health problems during treatment should seek immediate medical attention.
The agency clarifies what is already known about the drugs: even when used in approved doses and for registered indications, they can cause a wide range of mental disorders. Psychiatric disorders and suicidal ideation are already listed for some chloroquine and hydroxychloroquine products as rare side effects that occur with unknown frequency.
In Europe, chloroquine and hydroxychloroquine are not approved for COVID-19, but both drugs have been used off-label. According to the EMA, in randomized clinical trials these drugs did not show beneficial effects against COVID-19.
Last month, preliminary results from the British RECOVERY trial were confirmed – hydroxychloroquine and the combination of lopinavir/ritonavir did not show benefit in hospitalized patients with COVID-19. Previously, WHO refused to continue testing these drugs. Subsequently, a professor from France, who was one of the first to declare the benefits of hydroxychloroquine for coronavirus infection, was accused of promoting the drug.
Back in the spring, serious cardiotoxic effects of hydroxychloroquine were noted in different countries. Italian researchers also found that in patients with coronavirus infection, hydroxychloroquine can enhance the undesirable effects of other drugs.