Pharma & drug development

ConcePTION: tackling the unknowns of medication in pregnancy

The gaps in knowledge when it comes to the use of medication during pregnancy and breastfeeding are vast. A pan-European body called ConcePTION has been awarded a five-year grant by the Innovative Medicines Initiative to fill in the research gap. Abi Millar finds out more.

The majority of pregnant women take some kind of medication. Whether it’s for a pregnancy-associated ailment or an existing health condition, up to 90% are exposed to a prescription drug at some point during pregnancy. What’s more, usage of certain medicines (like antidepressants) is on the rise.

Unfortunately, relatively little is known when it comes to drug safety at this time. In some cases, otherwise safe medications can affect the growing foetus, increasing the risk of abnormalities. On top of this, drug pharmacokinetics (the way the drug moves round the body) can change during pregnancy, potentially altering the dosage required.

As Dr Miriam Sturkenboom, a professor at UMC Utretcht, explains, the information gap is vast. More than five million women in the EU get pregnant every year, and they are forced to contend with many unknowns.

“Only 5% of medications have been monitored, tested and labeled for use in pregnancy,” she says. “For the remainder it usually states ‘do not use’, to be on the safe side. The evidence on the possibility of using while breastfeeding is even less.”

She adds that this uncertainty falls squarely on the shoulders of the woman and the treating physician, who are tasked with making some complicated decisions.

“If a woman is not treated because of uncertainty, an uncontrolled disease may lead to damage for the mother and the foetus,” she says. “But if the woman is treated, health care professionals and the woman need to make a risk-benefit decision without proper evidence.”

Read the rest of this article in the September 2019 edition of Pharma Technology Focus


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