When it comes to drug labeling, the small print is vitally important. It tells us what to expect when we take a medicine. It reminds us of who should take it, and how often, and what to do if something goes wrong. And there’s an important regulatory side to it as well: pharma firms have to make sure that their labels tell patients exactly what they need to know.
But when it comes to pregnancy, it’s not so simple. As many drugs aren’t tested on pregnant women before they make it to chemists’ shelves, the advice is often to “consult your physician” before taking them. It’s quicker and easier than testing the drug on this population group.
This is hardly ideal. And the US Food and Drug Administration (FDA) knows it. Back in 2008, it realized that current labeling didn’t help either pregnant patients or their physicians, particularly since as many as half of pregnancies in North America are unplanned. Many women are potentially exposing themselves to risk by continuing to take drugs in the early stages of pregnancy.
While changing the information on leaflets is a slow process – the FDA has yet to implement change – the proposal is a promising start. The FDA aims to give both mothers-to-be and physicians clear guidelines about the use of medicines. Under the proposals, the old classification will be replaced with three main parts for pregnancy and lactation, summarizing the risk to the fetus, clinical considerations, and data available. If there’s information on this drug in the pregnancy exposure registry, that will appear on the drug label too.
Changing how information leaflets are written will take time, but it’s a step in the right direction. And it’s crucial that when implemented, the labels be written in clear language that allows mothers-to-be to understand the risks involved.