Pregnancy: a drug still too prescribed despite a risk of malformation

ANSM has published an information point on mycophenolate after an epidemiological study by the EPI-PHARE Scientific Interest Group. This medication is an immunosuppressant “widely used to prevent rejection after an organ transplant”, and it is also prescribed to treat certain autoimmune diseasesBetween 2010 and 2017, its use increased by more than 44% in women of reproductive age (13-49 years) took it, i.e. 17,726 patients. In 52%, they had a history of transplant. For the other identified diseases for which it has been prescribed, the most frequent are lupus erythematosus, multiple sclerosis and certain glomerulopathies. However, the National Security Agency for Medicines and Health Products recalls thatthere is a risk of congenital malformation and miscarriage.

Treatment is too often continued during pregnancy

The ANSM notes that there is a drop in the intake of mycophenolate during the preconception period and during pregnancy. For transplanted women, it has often been replaced by azathioprine (in more than 70% of cases). For patients with no history of organ transplant, it was either replaced with azthioprine or the treatment was interrupted, in a third of cases each time. Only, there are still too many pregnant women or in preconception who take it.

“The study identified 383 pregnancies for which at least one reimbursement of mycophenolate took place in the three months preceding and / or during pregnancy in France between 2010 and 2017”, explains the ANSM. 41% of them were interrupted by an abortion or an IMG.

Mycophenolate: a risk of malformation and miscarriage

The study shows that, in 12% of newborns exposed to mycophenolate, a diagnosis of malformation was made at birth. In addition, the ANSM recalls that taking this medication three months before or during pregnancy will cause “significant risk of miscarriage”.

What should be done ?

The ANSM therefore recalls that “mycophenolate is contraindicated in pregnant women and in women likely to procreate not using an effective and suitable contraceptive method, except in the absence of an appropriate therapeutic alternative, to prevent transplant rejection or to treat pathology. Mycophenolate is also contraindicated during breastfeeding“. It is therefore important that patients are informed of the risk by the doctor. In women of childbearing age, it is important to use contraception. For those who want to get pregnant, treatment should be stopped. At this time, the woman must continue “effective and suitable contraception for at least 6 weeks”.

What about men?

“Limited clinical data do not show an increased teratogenic risk for children born to a father treated with mycophenolate”, indicates the ANSM. Nevertheless, she adds that this drug “Being a genotoxic substance, the risk of genetic damage in the unborn child cannot be totally excluded. to avoid any risk, it is preferable to use an effective contraceptive method during treatment and for at least 90 days “ after stopping it.

Both in women and in men, treatment with mycophenolate should not be stopped without medical consultation. In case of desire to procreate or pregnancy, it is imperative to consult the doctor in charge of follow-up to know the procedure to follow and to obtain substitution treatment.