FDA is revamping Labels on Prescription Drugs

FDA is revamping Labels on Prescription Drugs

The Food and Drug Administration is revamping labels on prescription drugs so that it can be clearer to understand and safe to use especially for pregnant women and breastfeeding mothers.

A number of concerns are raised by pregnant women and breastfeeding mothers that a drug needed for them might prove dangerous for their baby or if women's changing body needs higher or lower dose.

Every year, in the US more than six million women become pregnant. As per the FDA, women take three to five prescription drugs during pregnancy. There can be pregnancy-related infection or morning sickness.

Already, they might be suffering from other problems, asthma, diabetes, epilepsy or depression. There can be more problems if they do not take proper treatment. The current system is developed in the 1970s.

In this system, letters of the alphabets are used to denote risk like 'X' is being used for the most dangerous, but as per doctors it is quite vague. There are many drugs that fall in a middle category, but often are denoted with a letter grade 'C'. The warnings were somehow confusing and outdated.

Jacques Moritz, Director of gynecology at Mount Sinai St. Luke's and Mount Sinai Roosevelt in New York, affirmed that the ABC system is not at all good. There was no known data during pregnancy. The new system divides the risk into three parts, pregnancy, lactation and fertility.

The companies are required to provide summary of the risk and other informatory facts, including existing human studies, any adverse reaction that can happen during pregnancy or lactation.

"More information about drugs will be provided than ever before", affirmed Dr. Sandra Kweder of the FDA's Center for Drug Evaluation. The information will be present on the official drug labeling that doctors are supposed to read when they decide prescription for patient.