How does a healthcare professional know if a drug is safe for use? Fortunately, all prescription and over-the-counter medicines go through a thorough clinical trials process, which lasts for several years. And regulators don’t launch a drug until they are convinced of its safety profile.
But in pregnancy, this distinction is less clear. There are fewer clinical trials that incorporate pregnant women – for fear of the adverse impact the drug could have on the unborn child. And this lack of knowledge means that, for many medicines, a doctor genuinely doesn’t know if a drug is safe for use during pregnancy. It’s very tricky for drug developers to strike a balance between offering mothers-to-be access to the very best quality of care, and guaranteeing that their unborn child will not suffer as a result.
The Centers for Disease Control and Prevention (CDC) in the US claims that there are huge gaps in what we know about drugs, and what we know about drug use in pregnancy. The CDC reports that a 2011 study of all the FDA-approved medications between 1980 and 2010 showed that there was insufficient data for 91% of the drugs to determine whether or not their use during pregnancy would put the mother and/or unborn child at risk.
The truth is that women are already using drugs while pregnant. CDC research claims that 70% of women take at least one prescription drug during pregnancy. Alarmed at the conflicting information available to pregnant American women about pregnancy and drug use, the CDC launched its Treating for Two program. This aims to find out more about medicine usage during pregnancy.
The FDA is also working to rewrite patient information leaflets, so that mothers-to-be have a clearer (if not definitive) idea as to whether or not a drug is safe. But the process has been ongoing for a few years now, and even when completed, it will not provide a black-or-white checklist for pregnant women.
As it stands, very few drugs are approved for use during pregnancy. But if we don’t start asking how to expand this list, pregnant women are at risk of being left behind in the world of drug development. And that’s not good for them, or their unborn child.