FDA Changes Labels on Pregnancy Drugs

The rules governing the prescription drugs used during pregnancy,child birth and lactation have been changed by the U.S Food and Drug Administration. The decision was in the pipeline since 2008 and will take effect from June 30, 2015. The labels on these drugs will be in accordance with a different and updated classification and categorization from what it has been. This will carry a tremendous impact on the pregnancies in the United States. A pregnant woman on an average are prescribed three to five drugs during gestation.

As pregnant women may suffer from conditions the drugs for which they must continue to take within pregnancy, it is important that mothers should be provided with a clearer understanding of the benefits and risks associated with these drugs. Same goes for drugs they may require for conditions that occur during pregnancy. The new classification of drugs will help not only mothers but also the health care providers into more educated choices of drugs, their effect and risks. The new system will provide the health care providers with more organized information on pregnancy and lactation. Current system involves designation of an alphabet to drugs which explains the risk of using these drugs during pregnancy and lactation. According to FDA authorities this classification is way too simple. It was also misinterpreted to be a grading system which explained the risk of using these drugs.

The new rule basically creates detailed subsections as opposed to alphabets that over simplistically exhibited the degree of risk a drug carried. The subsections from the new system are “pregnancy”, “lactation” and “females and males of reproductive potential”. The pregnancy subsection will provide data on drug dosage and the risk to the embryo. The new rule also emphasises on manufacturers maintaining evidence based data of how the drugs have been affecting
individuals using them.

The breastfeeding subsection will update physicians and mothers on how the drug in going to be secreted in breast milk and subsequently may have an impact on the neonate/infant. The last subsection will carry data about tests of pregnancy, infertility and contraception with respect to the drugs. The newly approved drugs will be labelled by the new rule whereas older product, gradually.

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