The U.S. Food and Drug Administration has created a new system of informing users about drug risks concerning pregnancy, lactation, and fertility.

The warning labels on drugs will no longer use the letter category system, but will instead include more a more detailed description of health risks. It is hoped that these new rules on drug labeling will be more communicative about pregnancy health risks.

Previously, the letter category system only included one letter that represented the level of risk that was associated with the medication: A, B, C, D, and X.

However, as FDA official Sandra Kweder explained, “the letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk.”

As drug use during pregnancy and lactation is a complicated matter, the FDA decided to require a system of warnings on drug labels that would better meet this complex matter.

On Dec. 3, the FDA issued their new rules. Labels will now have three detailed subsections on drug labels. The three sections will include the potential risks involving pregnancy, lactation, and female/male reproduction.

By separating the drug risks into smaller sections and adding more details, it is hoped that users will be more aware of the precise risks associated with taking a particular drug in their relevant stage.

The pregnancy subsection will include information specifically relevant to a fetus as well as how other pregnant women have responded to the drug. If the dosing information is different for pregnant women, that information will also be included in the pregnancy subsection.

The lactation subsection will naturally include information on drug risks concerning breast milk.

The “Females and Males of Reproductive Potential” subsection will give details on how the drug could potentially influence contraception, fertility, and pregnancy testing.

New FDA Rule Potential Outcomes

Both antidepressants and epilepsy medications have been accused of causing birth defects in children whose mothers took the drugs while pregnant. Drugs such as Zoloft, Prozac, Cymbalta, and Depakote have been associated with birth defects and birth defect lawsuits.

Birth defects that may have been caused by antidepressants or epilepsy medications include but are not limited to lung defects, heart damage, club foot, cleft lip, and craniosynotosis (misshapen head or skull).

Several studies have linked antidepressants to birth defects over the past several years. One study suggested that infants whose mothers took antidepressants during the first trimester are 60 percent more likely to develop heart problems.

Another study suggested that infants whose mothers took Depakote (for seizures or bipolar mood swings) are more likely to experience developmental problems in addition to other birth defects.

It is often very important that the mother take antidepressants or epilepsy medication, if needed, during pregnancy. But many individuals have not fully understood the risks and potential side effects associated with many drugs.

With the new FDA rule, it is expected that those birth defect risks will be better known. The choice of which drug to use and what the dosage should be may become clearer.

Many have filed birth defect lawsuits against drug manufacturers for failing to warn about the risks associated with drugs such Zoloft, Prozac, and others. Birth defect lawsuits seek compensations for medical expenses and other damages.