FDA Issues New Drug Label Rules to Better Inform Pregnant Women
FDA Issues New Drug Label Rules to Better Inform Pregnant Women
Agency official says labeling changes should help patients 'make critical decisions' about medicines
Also, changes that occur to a woman's body during pregnancy may affect the medication dose she requires, Kweder said.
The "Lactation" subsection on the new labels will provide more information on whether or not a medicine gets into breast milk and how that may or may not affect a breast-feeding infant. The "Females and Males of Reproductive Potential" subsection will also offer information about pregnancy testing, birth control and how a medicine affects fertility, the FDA said.
"For medications that may cause infertility or present risks in pregnancy, the revised labeling will include information to be considered when deciding such issues as birth control or planning a pregnancy," Kweder said.
It could take drug makers several years to make all the required label changes on older medications, according to the FDA.
"The greatest benefit to patients is that these changes will result in better-informed prescribing based on the latest scientific information for thousands of medical products," Kweder said.
Dr. Jacques Moritz, director of gynecology at Mount Sinai St. Luke's and Mount Sinai Roosevelt in New York City, welcomed the FDA's move.
"The alphabet grading system that was used previously was both antiquated and confusing," he said. "This is a great day for both pregnant women and physicians. Now patients are empowered to make a decision based on the risks and benefits of the drug in pregnancy and lactation. It is a much needed change from the previous system."
New Drug Labels to Better Inform Pregnant Women
Agency official says labeling changes should help patients 'make critical decisions' about medicines
Also, changes that occur to a woman's body during pregnancy may affect the medication dose she requires, Kweder said.
The "Lactation" subsection on the new labels will provide more information on whether or not a medicine gets into breast milk and how that may or may not affect a breast-feeding infant. The "Females and Males of Reproductive Potential" subsection will also offer information about pregnancy testing, birth control and how a medicine affects fertility, the FDA said.
"For medications that may cause infertility or present risks in pregnancy, the revised labeling will include information to be considered when deciding such issues as birth control or planning a pregnancy," Kweder said.
It could take drug makers several years to make all the required label changes on older medications, according to the FDA.
"The greatest benefit to patients is that these changes will result in better-informed prescribing based on the latest scientific information for thousands of medical products," Kweder said.
Dr. Jacques Moritz, director of gynecology at Mount Sinai St. Luke's and Mount Sinai Roosevelt in New York City, welcomed the FDA's move.
"The alphabet grading system that was used previously was both antiquated and confusing," he said. "This is a great day for both pregnant women and physicians. Now patients are empowered to make a decision based on the risks and benefits of the drug in pregnancy and lactation. It is a much needed change from the previous system."