The U.S. Food and Drug Administration (FDA) has announced a final rule that requires drug companies to outline the risks associated with taking medicine while pregnant and breastfeeding. The new system, said the FDA in a Dec. 3 news release, “will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.”
The new rule replaces the current letter categories – A, B, C, D, and X – used to classify the risk levels of taking medicines during pregnancy. The problem, according to Sandra Kweder, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, is that the “letter category system was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified view of product risk.”
One healthcare professional agrees.
“The A-B-C system was useless,” Jacques Moritz, MD, director of gynecology at Mount Sinai Roosevelt and Mount Sinai St. Luke’s in New York City, told the New York Times. “Everything was a ‘C,’ and all it said was there was no known data during pregnancy, but that wasn’t necessarily the case.”
The FDA’s new rule will require drug companies to use three risk subsections in their labeling. The pregnancy subsection will detail dosing information and a drug’s potential risk to the developing fetus. The subsection on lactation will spell out whether or not a drug gets into breast milk and the potential effects it will have on a breastfed child. The subsection on reproduction will include information on pregnancy testing, birth control and how the drug affects fertility.
“It [the rule] requires more information about drugs will be provided than ever before, and in a manner that speaks directly to the concerns” that doctors and their patients are likely to have, said Kweder. Now, added Kweder, doctors will have up-to-date information that will help them help their patients make informed decisions about their well-being during pregnancy.
All this is good news for the 8 million women in the U.S. who get pregnant each year. The FDA reports that pregnant women take an average of three to five prescription drugs during their pregnancy. Such cases may involve women who have asthma or high blood pressure and need to continue to take medications to treat their conditions. In addition, new or acute conditions can occur during pregnancy that may also require women to take medications while they are pregnant and breastfeeding.
“We know well there is a plethora of information out there about these drugs and companies have chosen not to include that information for whatever reason,” Kweder said. “Now they have to,” she added.
The rule goes into effect June 15, 2015. At that time, newly approved drugs and biological products will be required to use the new label format. Labeling requirements for previously approved drugs will be phased in gradually.