Hydroxychloroquine, azithromycin and ivermectin have been the subject of several studies since the start of the pandemic for their potential interest in the prevention and treatment of Covid-19. The ANSM recalls that these drugs have not demonstrated their effectiveness in these indications. The agency also alerts pregnant women to the risks associated with taking hydroxychloroquine during pregnancy. Explanations.
Hydroxychloroquine, azithromycin and ivermectin ineffective against Covid-19
Since the start of the Covid-19 pandemic, the debate on the interest of hydroxychloroquine in the prevention and treatment of SARS-CoV2 infection has never subsided. The ANSM has just recalled that to date the data published have not demonstrated any clinical benefit to use the following medicines for the prevention or treatment of Covid-19:
- L’hydroxychloroquine;
- L’azithromycin;
- L’ivermectin.
The sales data for these three drugs coincide with the evolution figures for theepidemic of Covid-19, suggesting their use. Published data on hydroxychloroquine, alone or combined with azithromycin, did not show clinical efficacy in the treatment of Covid-19 in adults. No data have been published in children. On the contrary, taking hydroxychloroquine exposes cardiac side effects potentially serious, including heart rhythm disorders. In addition, azithromycin is an antibiotic particularly at risk in relation to the development of bacterial resistance (antibiotic resistance). It should only be prescribed in the context of a medically diagnosed bacterial infection.
A risk of congenital malformation
With regard to ivermectin, randomized controlled trials have confirmed the absence of clinical efficacy of this drug in prevention or in the treatment of Covid-19. Irrespective of the dose used, ivermectin does not provide clinical benefit. Its tolerance is more uncertain, the doses used being higher than the doses prescribed in the usual indications of ivermectin (treatment of parasitic infections, such as scabies). The ANSM recalls that to date no public health authority, national or international, recommends the use of one of these three drugs in the prevention or treatment of Covid-19. The agency also issues an alert relating to the risk of congenital malformation when taking hydroxychloroquine during pregnancy.
A US study recently compared 2,045 pregnancies in which pregnant women were exposed to hydroxychloroquine during the first trimester with 19,080 pregnancies not exposed to the drug. The results showed an increased risk of congenital malformation in children, when the mother had been exposed to a daily dose of hydroxychloroquine greater than or equal to 400 mg.
Contraception recommended for women of childbearing age on hydroxychloroquine
The congenital malformations observed were considered serious, without the taking of the drug being associated with a specific type of malformation. For the experts, if the American study did not reveal any increased risk for doses lower than 400 mg, the precautionary risk must apply. In France, only one hydroxychloroquine specialty is currently available for the following indications:
The methods of prescribing and monitoring hydroxychloroquine will be modified to limit the risk of congenital malformations in the event of exposure in utero, as well as the leaflet of the medicine. A contraception is recommended for all treated women of childbearing age. The occurrence of a pregnancy under hydroxychloroquine should lead to immediate consultation with a doctor to assess the continuation or discontinuation of treatment.
Estelle B., Doctor of Pharmacy
Sources
– Children exposed to hydroxychloroquine during their mother’s pregnancy are at higher risk of severe birth defects. ansm.sante.fr. Accessed April 10, 2023.