Pregnant or lactating women fall into the category of special populations. How to manage pharmacovigilance in the event of an adverse event during pregnancy? Margherita D’Antuono, Pharm D, Ph D Corporate Pharmacovigilance Director and EU QPPV at Italfarmaco SpA spoke about this during the European Pharmacovigilance Congress.

Pregnant women are excluded from clinical trials, unless it is about a specially formulated drug for this specific situation. It is therefore difficult to assess the potential risk given the lack of information. However, there are cases in which the woman takes drugs due to particular pre-existing medical conditions: it is in these cases that pharmacovigilance must be even more active.

Cases of congenital anomalies or developmental delay, in the fetus or child, cases of fetal death and spontaneous abortion and cases of suspected adverse reactions in the newborn classified as serious should be given more attention and reported to the authorities.

Cases of exposure to contraindicated drugs during gestation or medicines with a high teratogenic potential may also need to be notified, although with positive pregnancy outcome: often, in fact, pregnant women, or health professionals, contact the MAH to request information on the teratogenic potential of a drug taken before the woman knew about the pregnancy or without realizing the possible effects on the fetus. This is a real opportunity to collect data on the exposure.

The MAH must implement additional measures in the following situations:

  • cases of congenital malformations: provide a complete description of the malformation
  • cases of spontaneous abortion: specify the time of occurrence and the history of spontaneous abortion
  • cases of termination of pregnancy after the first trimester: obtain and provide the results of fetal autopsy and prenatal tests
  • cases of late fetal death: collect prenatal test results, such as ultrasound, amniocentesis, serum markers etc., autopsy results, if available, and other factors that may have had an impact on fetal loss, such as diseases concurrent
  • cases of paternal exposure: collecting information also on the father
  • cases of taking medicines with teratogenic or fetotoxic effects: provide information on the outcome of the pregnancy.

In case of Adverse Event during the pregnancy, how many ICSRs must be created?

  • In cases of abortion or death of the fetus without malformations: only one ICSR for the mother
  • in cases of fetal malformations: an ICSR for the fetus and one for the mother, but only in the case in which her too have encountered an adverse event
  • in the event of birth defects: an ICSR for the fetus and one for the mother, but only in the case in which her too have encountered an adverse event
  • in the case of twins: one ICSR for each of the fetuses.

In conclusion, there are several doctors who prescribe drugs to pregnant or lactating women without knowing the potential risks or actual effectiveness; however, the MAH must ensure that it has done everything possible to collect the information necessary to improve the risk/benefit profile of the product.