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 FDA Alerts
August 24, 2022

Pregnant or Breastfeeding? FDA Aims to Improve Drug Information

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Information about the dosing and effects of the medicine have not been fully studied in women who are pregnant or breastfeeding. Therefore, your doctor may recommend that you avoid taking prescription and/or over-the counter (OTC) medicines while pregnant or breastfeeding.

However, the past few decades have seen an increase in prescription medicine use while pregnant or breastfeeding. Medical or pregnancy-related conditions (such as asthma, high blood pressure, and depression) may require ongoing treatment with prescription medicines. So, treatment options need to be discussed with your healthcare provider.

The US Food and Drug Administration (FDA) has identified the need to obtain accurate data on the use of medicines during pregnancy and breastfeeding. To do this, they have developed guidelines to help drug companies and researchers create studies that include people who are pregnant or breastfeeding. The information gathered from these studies may help improve information about the use of the medicine while pregnant or breastfeeding.

Here’s what you can do: If you are pregnant and/or breastfeeding, talk to your healthcare provider about any medicines you may need to take or continue to take. If you have a medical condition that requires the use of a prescription or OTC medicine, you and your healthcare provider should discuss starting, continuing, changing, or stopping the medicine while you are pregnant or breastfeeding. You can also ask your healthcare provider or contact the FDA for more information about participating in a study.

Advice from FDA is a feature brought to you by FDA. You can find this information and more on FDA’s Consumer Health Information website at: www.ismp.org/ext/928. This website features the latest updates on medicines and products regulated by FDA. Sign up for a free email subscription at: www.ismp.org/ext/262.

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Pregnant or Breastfeeding? FDA Aims to Improve Drug Information