FDA Passes New Rules to Protect Expectant Mothers and Infants from Dangerous Drug Reactions

Last month, the U.S. Food and Drug Administration (FDA) issued a new rule regarding the information pharmaceutical companies must include on prescription drug labels. Specifically, the rules address warnings for women who are pregnant or breastfeeding and the risks which may be associated with a particular medication.

Drugs which are not labeled properly can be dangerously unsafe or defective, and without adequate information, doctors may prescribe the wrong medications or dosages, causing serious personal injury or wrongful death to a pregnant woman, the fetus, or a breastfeeding infant. It is hoped that the new rules will lead to better information for doctors and patients alike.

Old Rules Were Overly Simplistic and Confusing

Under the old rules, drugs were placed into one of five categories labeled A, B, C, D and X according to their risks for pregnant women. These categories were simply too broad and simplistic to provide helpful information to doctors and patients when deciding whether a particular medication was safe, or whether the potential for harm outweighed the benefits. For instance, drugs were placed in category C if animal studies showed potential risks to a fetus even though no adequate studies on humans had been conducted. It was often simply impossible, based on the label, for anyone to know whether a particular drug in that category was dangerous to prescribe during pregnancy or not.

New Rules Provide Clear and Abundant Information

The new system addresses risks in three different areas: pregnancy; lactation or breastfeeding; and fertility, including how the drug may affect pregnancy testing, contraception and infertility in females as well as males. The pregnancy and lactation sections are further divided into three sub-areas including a “risk summary,” “clinical considerations” and “data.” This way, doctors will be able to quickly find information about a drug as well as examine the ramifications of a medication in more detail when necessary.

The new rules will go into effect on June 30^th of this year. Meanwhile, the FDA will issue draft guidance for industry to help drug makers understand and comply with the new legal requirements.