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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 is still very limited and unclear.
The Federal Institute for Drugs and Medical Devices (BfArM) notes in a current communication that the European Medicines Agency (EMA) recalls on its website the risk of serious side effects when using hydroxychloroquine (and chloroquine).
Hydroxychloroquine is an approved medication for the treatment of malaria.
Currently, the drug is also used against COVID-19.
This is not without risks, because studies have linked the drug to severe, in some cases fatal, arrhythmias.
The medicine used to treat COVID-19 carries a risk of serious side effects.
For example, US researchers. USA They reported in an article published on the medRxiv prepress server that hydroxychloroquine has no positive effect in people with COVID-19.
In contrast, the mortality rate was even higher among patients treated with the preparation.
But other investigations are still ongoing.
According to the BfArM, hydroxychloroquine and chloroquine in relation to 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 on the heart.
A study recently published on the medRxiv prepress server indicates an increased risk of cardiac side effects and increased cardiovascular mortality when hydroxychloroquine is used concomitantly with azithromycin.
In addition to side effects that affect the heart, the drug is known to cause liver and kidney function disorders, damage to nerve cells that can lead to seizures, and low blood sugar levels (hypoglycemia).
Hydroxychloroquine is currently approved for the treatment of malaria and certain autoimmune diseases.
ECG checks should be considered before and regularly during therapy.
According to the BfArM, healthcare professionals should carefully consider the risk of side effects, especially at higher doses, and be especially careful when combining this treatment with other medications such as azithromycin, which can have similar side effects on the heart.
Health 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 heartbeats.
While serious side effects may already occur at recommended doses, the risk of such side effects increases again when higher doses are used, explains the BfArM.
This is reported to apply in particular to disturbances in electrical conduction to the heart that impair heart rhythm (QT prolongation).