Drug for treatment of COVID-19 poses a risk for 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 harmless, because in studies of the Mediterranean, with serious, in some cases, fatal cardiac arrhythmias have been brought in connection.
The Federal Institute for drugs and medical devices (BfArM) has in a recent communication, the European medicines Agency (EMA) on their website to the risk of serious side effects with the use of hydroxychloroquine (and chloroquine) reminds.
Hydroxychloroquine is used during the current Coronavirus pandemic, for the treatment of patients with COVID-19 and in clinical studies. The clinical data are still very limited and not clear.
As Researchers reported, for example, from the USA in a on the Preprint Server medRxiv published articles that hydroxychloroquine has no positive effect on people with COVID-19. In the drug-treated patients were quite on the contrary, the mortality rate increases.
However, other investigations are still in progress.
Medicines apply under any circumstances without medical supervision
According to the BfArM, hydroxychloroquine and chloroquine should not be used in connection with COVID-19, preferably in the framework of clinical studies used. The medication should never be used without prescription and without medical supervision applied.
The experts suggest that hydroxychloroquine is known that it can cause heart rhythm disorders. These disorders may be exacerbated by the concomitant administration of other active ingredients (such as, for example, of the antibiotic Azithromycin), can cause heart related side effects.
A recent Preprint Server medRxiv published study indicates an increased risk for cardiac side effects and an increased cardiovascular mortality with the concomitant use of hydroxychloroquine with Azithromycin.
Side effects not only 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, causing the agents known to be potentially disorders of the liver and kidney function, nerve cell damage, which can lead to epileptic seizures and low blood sugar (hypoglycemia).
While already at the recommended doses, serious side effects can occur, increasing the risk for such side effects with the higher doses, again, explains the BfArM. According to the figures, this is especially true for disorders of the electrical conduction of the heart that affect the heart rhythm (QT prolongation).
Monitor patients carefully
Members of the medical profession, it is recommended that patients with COVID-19, the hydroxychloroquine get to closely monitor and to take into account pre-existing heart disease, the patients may be more vulnerable for heart rhythm disorders.
ECG checks before the start and regularly during the course of therapy should be considered.
Healthcare professionals should weigh according to the BfArM, the risk of side-effects especially at higher doses carefully and be particularly careful if you combine this treatment with other medicines such as Azithromycin similar side effects on the heart can have.
Report suspected side effects to
Patients and healthcare professionals are asked to report any suspected cases of side-effects. Information on this website.
The BfArM and the other competent national authorities to observe, together with the EMA of the Situation and have stepped up their safety monitoring of medicines used in the treatment of COVID-19, to be able, if necessary, take action on time.
The Institute has summarized on a special page detailed information on Off-Label Use of hydroxychloroquine in COVID-19. (ad)