Current FDA guidelines about medication safety during pregnancy can be very confusing for women and their health care providers. Soon, however, doctors will have access to more information about the safety of prescription drugs during pregnancy.
When you are pregnant, you try to avoid anything that may harm your baby. But sometimes, you need to take medications for your own health. Managing chronic conditions like diabetes, asthma, and high blood pressure is very important, especially during pregnancy. But it is often difficult to know what medications are safe. And current FDA safety categories can be very confusing and difficult to understand.
However, in the summer of 2015, drug manufacturers will need to start providing additional details about medication safety in pregnant and breastfeeding women. The new labels will have to state how the safety information was obtained and whether the data was the result of scientific studies in people, or if it was obtained through study of animal models. The manufacturers must also include how much of the drug is excreted in breast milk and whether it affects the nursing baby, as well as how the drug may affect future fertility for both men and women of reproductive age.
These changes in labeling will provide doctors with more information about a medication’s safety during pregnancy. The information will not be on the actual medication bottle. It will be included in the official drug labeling information that doctors use when prescribing medications. It may also be included in the printed materials that pharmacies often include when filling prescriptions. This change in labeling does not apply to over-the-counter medications, though.
The new guidelines will allow doctors and patients to weigh the pros and cons of which medication is best to take during pregnancy for a given condition based on scientific evidence. And it will provide doctors and patients with more safety data than has previously been readily available.
The March of Dimes hails the release of the FDA’s final rule on pregnancy and lactation drug labeling information for prescription drugs. According to Dr. Jennifer Howse, president of the March of Dimes the new rules “will drive critical improvement to prescription drug labels regarding known effects on pregnancy, breastfeeding, and fertility. The rule takes vital steps to improve the organization, readability, and usefulness of this information, which will enable women and their providers to find it and use it more readily….It is important to note, however, that this rule is only a first step, and it does not address other crucial issues related to pregnancy, lactation, and prescription drugs. The March of Dimes looks forward to working with the FDA and other interested stakeholders to ensure that appropriate research is performed and data generated to allow women and their health providers to make fully informed decisions about medication and its expected impact on pregnancy, lactation and childbearing.”