Label changes on drugs for pregnant and lactating women

Health News

Drug companies will have to change the way they label drugs so that pregnant and breastfeeding women understand the potential risks better, FDA’s Center for Drug Evaluation and Research deputy director Dr. Sandra Kweder told a news conference on Wednesday. The ruling, to be published Thursday in the National Register, replaces the 40-something years old A, B, C, D and X system with three more clearly defined new categories: pregnancy, lactation, and females and males of reproductive potential. The new system has been in development since 2008, and will become effective starting June 30.

In the current system, X designates the most dangerous drugs, but many drugs that fall into a middle category are given a C grade. This sends users mixed signals; that animal studies have shown potential danger to the fetus, but that there are no proper human studies. “The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk,” Kweder said. “The A B C system was useless,” director of gynecology at Mount Sinai St. Luke’s and Mount Sinai Roosevelt in New York Jacques Moritz concurred. “Everything was C, and all it said was there was no known data during pregnancy, but that wasn’t necessarily the case.”

Kweder agreed. “Often times the research is out there in the medical literature and often times companies know about that information … and they have chosen for whatever reason not to update their labeling,” she said. “This pushes the envelope and says you need to do that.” Sometimes the information was there but finding it was like finding Waldo. “This information has been in labeling all along, but it’s been scattered throughout the label and very difficult to find. We’re putting it all in one place,” said Kweder.

The three new categories “will require that labeling include a summary of the risks of using a drug during pregnancy and while breastfeeding an infant,” Kweder explained.

• Pregnancy. Dosing and potential risks to a developing fetus. This subsection will also require – not recommend as previous regulations did – that info on registries that gather data on the drug’s effects is included.
• Lactation. How much of the drug passes into breast milk and the possible effects on a lactating child.
• Reproductive potential. Impact on pregnancy testing, contraception, and infertility. This information has been inconsistently placed in current labels.

These three subsections will be included in the prescribing information – or package inserts – that the doctor writes, and will not affect the labeling on the outside of pill containers. Kweder said that the new format “requires that more information about drugs will be provided than ever before, and in a manner that speaks directly to the concerns” of the more than six million pregnant women a year in the United States, who take 3 to 5 prescription drugs on average.

Related Read:

F.D.A. Revamps System explaining the Risks of medicines during Pregnancy.

Pregnant and breastfeeding mother area focus of new drug labeling rule.

FDA changes labeling for drugs used during pregnancy, lactation.

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