Pregnant women can take Tamiflu in case of flu and be vaccinated against the H1N1 strain without risk to their health and that of their baby according to the results of a double scientific study by the National Institute of Health and Research medical (Inserm).
Assessing the safety of Tamiflu
For reduce the risk of infectionand complications (hospitalizations, miscarriages or premature deliveries), pregnant women are prescribed Tamiflu or are vaccinated against the H1N1 virus strain from the second trimester of pregnancy.
“But when a drug is put on the market, we do not have any safety data on pregnant women. Clinical studies on this category of people are almost non-existent for ethical reasons. Only information from animal tests is accessible, and it is not always extrapolable. This is why it is necessary to be able to conduct studies a posteriori, and independently from the companies that market these products, ”explains Isabelle Lacroix, coordinator of this work.
This is why the National Agency for the Safety of Medicines and Health Products (ANSM) asked the service of the University Hospital of Toulouse to assess the safety of Tamiflu and the vaccine against the H1N1 strain in pregnant women.
To carry out their studies, the researchers used the EFEMERIS database (Evaluation in Pregnant Women of Medications and their Risks) in Haute-Garonne, which allowed them to cross-check medication taken and vaccinations against H1N1 influenza during the period. pregnancy with the course of it and the state of health of babies. Between 2004 and 2010, nearly 50,000 women took Tamiflu.
Thanks to this very rich database, scientists were able to analyze the consequences of taking Tamiflu or vaccination against H1N1 on the health of pregnant womenand their infants.
“In both cases, the results are very reassuring. Although a number of a few thousand women to assess the safety of the vaccine is a fair bit to detect a risk of a rare malformation, these results show no association between the use of these products and a risk of miscarriage, prematurity, low birth weight, neonatal pathology or even malformation, ”concludes Isabelle Lacroix.
