The FDA's Pregnancy and Lactation Labeling Rule, which makes risks easier to understand, is helping women lead healthier pregnancies, according to new research.
A two-year-old FDA rule requiring clear labeling of medications used during and after pregnancy helps doctors better communicate the details of each drug, according to a new study by the Pregnancy and Lactation Labeling Rule.
The rule mandates that labels clearly include detailed information about scientifically backed risks associated with each medication. New evidence illustrates that it's working to help pregnant and lactating women make better decisions about medicines taken during this important time frame.
According to the paper, which was published in Pediatric Allergy, Immunology, and Pulmonology, drugs tend to be cleared for use before there's enough human data to identify possible risks. But under the rule, drug companies are required to clearly indicate any risks for pregnant or lactating women and update their labels as new information from researchers surfaces.
Researchers indicate that including information from both the academic community and the pharmaceutical industry, which helps medical professionals better understand the risks to their patients before making the decision to take any medicine.
"Healthcare providers responsible for counseling patients who are pregnant, planning to become pregnant, and those who are breastfeeding need a reliable source of information about prescription medications," Pediatric Allergy, Immunology, and Pulmonology Editor-in-Chief Mary Cataletto, MD, said in the study's release. "The new labeling requirement provides a more user-friendly presentation of studies, registries, and available information that can be used to assist providers in discussing medication risks and benefits with their patients."