Safety of drugs in pregnancy

A broad collaboration is underway between the World Health Organization (including TDR) and external partners to assess the consequences to mothers and their newly born children of drug exposure during pregnancy. The collaboration establishes the safety of any drug exposure, such as antiretrovirals for HIV, malaria medicines, and treatment for schistosomiasis, visceral leishmaniasis and other parasitic diseases.

A standard protocol for the collection of data on congenital abnormalities related to possible drug exposure in pregnancy in resource-poor settings has been piloted. The research was embedded within the health system of participating countries at sentinel sites.The Alliance for Health Policy and Systems has added Burkina Faso to the contributing countries, each of which owns its own data and contributes to a common data pool.

TDR is now developing a central registry for the collection and collation of data from pregnancy registries. This work is developed in collaboration with other WHO departments, in particular the HIV department, which recommends toxicity surveillance during pregnancy in the context of antiretroviral use. It will help also collecting data that may be relevant for other control programmes (e.g. malaria, tuberculosis) where important questions remain on the use of some drugs during pregnancy. The goal of the central registry is to enable the early detection of any potential signal of teratogenicity and provide evidence to inform treatment guidelines for pregnant patients.

Watch a video in Burkina Faso on a research study on community volunteers providing malaria and pneumonia treatment