The Belgian AFMPS warns about risk of hemolysis associated with the use of hydroxychloroquine

Hogan Lovells
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Hogan Lovells

[co-author: Vicky Vlontzou]

On 14 April 2020, the Belgian Federal Agency for Medicines and Health Products (AFMPS), published a news flash warning physicians of the risk of hemolysis associated with the use of hydroxychloroquine in patients with glucose-6-phosphate dehydrogenase (G6PD). The warning was published after the AFMPS received a report of an adverse reaction to a Belgian patient in the context of COVID-19 treatment. The AFMPS news flash provides recommendations to prevent the occurrence of similar adverse events in the future during treatment of COVID-19.

The Belgian Federal Agency (AFMPS) has warned physicians about the risk of hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) from treatment with hydroxychloroquine. The AFMPS published a news flash following an adverse reaction reported to the Agency regarding a Belgian patient who presented hemolysis stigma two days after having been treated with hydroxychloroquine (PLAQUENIL) in the context of their treatment for COVID-19. The patient received a red blood cell transfusion and folic acid and the treatment was continued. After being discharged from hospital the patient’s biological examination revealed a G6DP deficiency, suggesting hydroxychloroquine could have been the cause of hemolysis in this context.

According to the AFMPS hydroxychloroquine is not contraindicated in treatment of patients with G6PD deficiency but it should be administered with caution. Among the types of G6PD deficiency, the Mediterranean type probably presents the greatest risk of medicine-induced hemolysis.

Data regarding a causal relationship between hydroxychloroquine and the risk of hemolysis in patients with other diseases such as, systemic lupus erythematosus, rheumatoid arthritis, and inflammatory arthritis are conflicting.

The AFMPS notes that there are no cases of hemolysis reported in patients with COVID-19 in scientific literature, nor do any other similar adverse reactions exist in the European pharmacovigilance database, EudraVigilance. It also notes that data regarding the use of hydroxychloroquine in the context of COVID-19 are still very limited.

The AFMPS, nevertheless, recommends the following

  1. To prevent similar adverse reactions from occurring, the AFMPS does not advise conducting pre-emptive biological searches for G6PD. However, it notes that the deficiency is among the precautions that need to be taken into consideration when treating patients.
  2. The AFMPS recommends that patients be asked about a potential G6PD deficiency at the time of their admission to hospital. It also advises that physicians pay particular attention to the signs and symptoms of hemolysis during hydroxychloroquine treatment both during as well as after the therapy due to the medicine’s prolonged elimination half-life.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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