Hydroxychloroquine is used during the current coronavirus pandemic to treat patients with COVID-19 and is being investigated in clinical studies.
However, the clinical data are still very limited and not clear.
The Federal Institute for Drugs and Medical Devices (BfArM) points out in a current communication that the European Medicines Agency (EMA) reminds on its website of the risk of serious side effects when using hydroxychloroquine (and chloroquine).
Hydroxychloroquine is a drug approved for the treatment of malaria.
Currently, the drug is also used against COVID-19.
This is not without risk, because studies have linked the drug to serious, in some cases fatal, arrhythmias.
Drug used to treat COVID-19 carries a risk of serious side effects
For example, researchers from the USA reported in an article published on the preprint server medRxiv that hydroxychloroquine has no positive effect on people with COVID-19.
On the contrary, the mortality rate was even higher among the patients treated with the preparation.
But other investigations are still ongoing.
According to the BfArM, hydroxychloroquine and chloroquine in connection with COVID-19 should preferably be used in clinical studies.
The medication should never be used without a prescription and without medical supervision.
Increased mortality
According to experts, hydroxychloroquine is known to cause cardiac arrhythmia.
These disorders can be exacerbated by the simultaneous administration of other active substances (such as the antibiotic azithromycin), which can trigger similar side effects in the heart.
A study recently published on the preprint server medRxiv indicates an increased risk of cardiac side effects and increased cardiovascular mortality when hydroxychloroquine is used concomitantly with azithromycin.
In addition to the side effects that affect the heart, the drug is known to potentially cause liver and kidney function disorders, nerve cell damage that can lead to epileptic seizures, and low blood sugar (hypoglycemia).
Hydroxychloroquine is currently approved for the treatment of malaria and certain autoimmune diseases.
ECG checks before and regularly during therapy should be considered.
According to the BfArM, healthcare professionals should carefully consider the risk of side effects, especially at higher doses, and be particularly careful when combining this treatment with other medicines such as azithromycin, which can have similar side effects on the heart.
Healthcare professionals are advised to closely monitor COVID-19 patients receiving hydroxychloroquine and to consider pre-existing heart conditions that may make patients more susceptible to irregular heartbeat.
While serious side effects can already occur at the recommended doses, the risk of such side effects increases again when higher doses are used, explains the BfArM.
According to the information, this applies in particular to disturbances in the electrical conduction to the heart that impair the heart rhythm (QT prolongation).
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