Drug used to treat COVID-19 carries a risk of serious side effects
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.
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 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.
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.
Do not use medication without medical supervision
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.
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.
Side effects don’t just affect the heart
Hydroxychloroquine is currently approved for the treatment of malaria and certain autoimmune diseases.
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).
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).
Monitor patients closely
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.
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.
Report suspected side effects
Patients and healthcare professionals are asked to report any suspected side effects. There is information on this on this website.
The BfArM and the other competent national authorities are closely monitoring the situation together with the EMA and have strengthened their safety surveillance of medicinal products used in the treatment of COVID-19 in order to be able to take measures in good time if necessary.
The institute has summarized detailed information on the off-label use of hydroxychloroquine in COVID-19 on a special page. (ad)
- Federal Institute for Drugs and Medical Devices (BfArM): Hydroxychloroquine: Risk of serious side effects when used to treat COVID-19, (accessed: May 2, 2020), Federal Institute for Drugs and Medical Devices (BfArM)
- European Medicines Agency (EMA): COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine, (access: 02.05.2020), European Medicines Agency (EMA)
- Lane et al .: Safety of hydroxychloroquine, alone and in combination with azithromycin, in light of rapid widespread use for COVID-19: a multinational, network cohort and self-controlled case series study; medRxiv, (published: April 10th, 2020), medRxiv
- Joseph Magagnoli, Siddharth Narendran, Felipe Pereira, Tammy Cummings, James W. Hardin, S. Scott Sutton, Pharm.D., Jayakrishna Ambati: Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19; medRxiv, (published: April 21, 2020), medRxiv
- Federal Institute for Drugs and Medical Devices (BfArM): Report of side effects in connection with COVID-19, (accessed: 02.05.2020), Federal Institute for Drugs and Medical Devices (BfArM)
- Federal Institute for Drugs and Medical Devices (BfArM): RSS-Feed: Coronavirus SARS-CoV-2, (accessed: 02.05.2020), Federal Institute for Drugs and Medical Devices (BfArM)
This article contains general information only and should not be used for self-diagnosis or treatment. He can not substitute a visit at the doctor.