Personal Injury Law

Proposed Label Changes Help Moms On Medication

By Jane Akre

During the approximately six million pregnancies in the U.S. every year, women take an estimated three to five prescription medications.

After giving birth, more than 90 percent of new, nursing mother take medication in the first week.

So knowing if a drug is safe for mother and child is crucial.

The system for determining safety is 30-years-old and sometimes confusing, so the Food and Drug Administration (FDA) is proposing changes to the labels of prescription medications.

The label changes will include three sections that discuss what is known about a drug and its effect on pregnancy. 

"With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit," said Dr. Sandra Kweder, FDA Center for Drug Evaluation and Research, said in a statement.

Currently prescription medications are put into various letter categories - A, B, C, D or X - to denote their safety to a woman and her unborn baby.  These categories can be confusing, are often very broad, and encompass drugs of significantly different risks. 

For example, Category C, the largest category, includes both drugs that were found to do some harm in animals, as well as drugs that were not tested on animals, and on pregnancy. 

The FDA has been trying to find a better system since 1997 to clear up questions about whether a drug is safe to take during pregnancy, and whether the benefits outweighed the risk to mother and fetus.

The new rules will eliminate the letter system and replace it with three sections:

• "Fetal Risk Summary" - will describe what's known about the risk of the drug to the fetus and what data is known about the effects from animal or human studies. A risk conclusion would be added such as "Human data indicate that (drug) increases the risk of cardiac abnormalities."
•  "Clinical Considerations" - includes information about the effects of the drug if taken before a woman knows she is pregnant and would include information on the risks of the disease to the mother and baby, dosing information and how to address complications.
• "Data" - describes with more detail the available data on the effects of the drug in human and animal studies noted in the Fetal Risk Summary.

After 90-day comment period, if the proposal for label change is adopted, drug companies would be required to update labels as information becomes available through research and product testing. 

If testing finds that a medication is safer than once thought, that information will be added as well, making pregnant women aware of a potentially helpful drug.  #

Full post as published by InjuryBoard on May 29, 2008 (boomark / email).