COVID-19: Facts about chloroquine and hydroxychloroquine

07 April 2020

There are many rumours that hydroxychloroquine or chloroquine has a documented effect on COVID-19 and that other countries have approved it for COVID-19. Read the facts here.

Hydroxychloroquine is a medicine in tablet form authorised in the EU for the treatment of arthritis and skin diseases and for the prevention of malaria. The fact that the medicine is authorised means, in this context, that the authorities have granted a marketing authorisation to the company which manufactures the medicine. The marketing authorisation allows the company to sell the medicine for the treatment of precisely these diseases. The marketing authorisation has been granted based on documentation from the company that hydroxychloroquine is effective on these diseases and is safe to use. There is a medicine called chloroquine, and there is a medicine called hydroxychloroquine. Only hydroxychloroquine is sold in Denmark.

Since 23 March 2020, hydroxychloroquine in Denmark can only be prescribed by hospital doctors and specialist doctors for rheumatic disorders, skin diseases and childhood diseases as well as only be used in clinical trials. This means that Danish hospital doctors, for example in connection with research projects, have the possibility of testing if hydroxychloroquine has an effect in COVID-19 patients. In principle, Danish hospital doctors are also allowed to use hydroxychloroquine to treat COVID-19 patients even if they are not enrolled in research projects. This is because doctors have the right to prescribe the medicine of their choice according to their assessment and under their own responsibility.

The Danish Medicines Agency cannot authorise hydroxychloroquine for COVID-19 if the company manufacturing the medicine does not apply for an authorisation. Marketing authorisations are granted based on the initiative of the company. In addition, marketing authorisations are based on documentation of efficacy and side effects, and more. Right now, only very few studies have been conducted to investigate the effect of chloroquine and hydroxychloroquine on COVID-19, and their total evidence base is not solid enough to assess if chloroquine or hydroxychloroquine has a real effect on COVID-19. Likewise, it has not been established what side effects the medicines could cause when used to treat COVID-19.

Other countries’ reports on chloroquine and hydroxychloroquine

Right now, there are many reports in the press and social media claiming that drug regulatory authorities in other countries have authorised chloroquine or hydroxychloroquine for the treatment of COVID-19. It is important to note that the authorities in other countries have not issued marketing authorisations that allow chloroquine or hydroxychloroquine to be marketed as a treatment for COVID-19. The case here is that doctors in other countries have been given possibilities to use the medicines to treat COVID-19 patients. Possibilities that are similar to those given to Danish hospital doctors.

USA’s reports on chloroquine and hydroxychloroquine

The FDA has granted a special permission to use chloroquine and hydroxychloroquine in clinical trials and in emergency situations. This is not a genuine authorisation, but a possibility given to American doctors to use chloroquine in COVID-19 clinical trials and in the treatment of COVID-19 if the doctor has no other options.
See the FDA’s announcement here.

European Medicines Agency (EMA)

The EMA has announced that chloroquine and hydroxychloroquine should only be used for the treatment of COVID-19 in connection with clinical trials or in national emergency use programmes for the treatment of critically ill COVID-19 patients. Denmark is thus in line with the recommendations from the European Medicines Agency, offering the same possibilities to use hydroxychloroquine in clinical trials and allowing hospital doctors to prescribe it. See the EMA’s announcement here.

The authorisation in Poland

Poland is the only country to have actually authorised a chloroquine-containing product for supportive treatment of COVID-19. The product concerned is produced locally and called Arachin. It is manufactured by the Polish company Adamed Pharma. The Danish Medicines Agency has not seen the Polish company’s authorisation basis, and the drug regulatory authorities in Poland have informed us that use of the product is only permitted in hospitals in Poland. Denmark can neither assess nor issue a marketing authorisation for a Polish product if the Polish company has not submitted an application to the Danish Medicines Agency with the intent of putting it on the Danish market. See Poland’s announcement here.

The Danish Medicines Agency has also investigated how several other European countries like the UK, Spain and Belgium have approached the question of hydroxychloroquine and COVID-19. Several other European countries have also emphasised that hydroxychloroquine is not authorised for COVID-19, and that there is presently no evidence of the treatment. Several countries have announced that they indeed prefer the treatment to be conducted as part of clinical trials.

The Danish Medicines Agency is following international research closely. At present, there are not enough scientific studies to draw any conclusions on the effect of chloroquine and hydroxychloroquine on COVID-19.