FDA To Revise Drug Labels For Pregnant Women

The U.S. Food and Drug Administration plans to revise labeling on drugs meant for pregnant and nursing women as a potential step in creating awareness on risks associated with it. This will help doctors with their prescription practices and help them understand the drug in a better way.

Dr. Sandra Kweder, deputy director of FDA's Office of New Drugs, Center for Drug Evaluation and Research, said “The system of letter categories has led to an inaccurate and overly simplified view of prescribing in pregnancy. This system also makes it very difficult to update labeling as new information becomes available."

The new regulation is set to replace the already existent system that uses lettered markings to indicate the potential risks of the drug for pregnant and breast-feeding women and also to their fetus and newborns respectively. This system is said to have many inaccuracies in labeling which confuses doctors and pharmacists.

If the new proposal gets sanctioned, then medical practitioners can get comprehensive guidance while prescribing drugs to pregnant and nursing women, where some have pre-existent medical conditions like blood pressure, diabetes or asthma. The new elaborate labels intend to include three topics.

First part of information will detail "Fetal Risk Summary," describing the drug’s effects on the fetus and whether if the finding is supported by animal or human research.

Second part titled, "Clinical Considerations," would list effects of the drug if it were taken before a woman knows she is pregnant. This will include risks to the mother and baby or fetus according to the amount of dose administered and ways to deal complications.

The third part titled "Data," will detail the information about the use of drug in research on human and animal subjects for developing the "Fetal Risk Summary." The last part of label i.e. breast-feeding section provides information about drug’s usage and dosage while nursing.

The proposed changes will be reviewed with comments,invited from stakeholders. After the review FDA will finalize the label layout following which, new drugs will be required to adopt the revised labeling format. But officials said that the entire procedure will take a minimum of one year.