• FDA

    Taking a Look at the New FDA Pregnancy Labeling and Lactation Rule

    The U.S. Food and Drug Administration (FDA) has proposed major revisions to prescription drug labeling in order to provide more accurate and helpful information on the effects of medications used during pregnancy and breastfeeding. The [...]

    FDA Finalizes Guidelines for Pregnancy and Lactation Labeling Information

    Last week, the U.S. Food and Drug Administration (FDA) published a report outlining the new standards for how to present information regarding the safety of medications used during pregnancy and breastfeeding: “The new content and formatting requirements 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.”  These changes will be put into effect by June 2015.

    Valproic Acid and Pregnancy: FDA Issues Warning

    There have been multiple recent reports indicating that the use of valproate during pregnancy may be associated with lower IQ, cognitive problems, and developmental delays in exposed children.  This has prompted the FDA to issue a warning regarding the use of valproate-containing drugs, including Depakote and Depakene, during pregnancy:

    Yaz and Other Oral Contraceptives Will Carry a New Warning Label

    The FDA will require Yaz, Yasmin and several other newer oral contraceptives to carry new warning labels that detail the potential risk of venous thromboembolism (VTE or blood clots).  All oral contraceptives increase the risk of blood clots; however, recent studies have suggested that birth control pills containing drospirenone, a synthetic form of the hormone progesterone, may carry a slightly increased risk of VTE, compared with older birth control pills.  The FDA estimates that over a one year period, 10 in 10,000 women taking an oral contraceptive with drospirenone would develop a blood clot , as compared to about 6 in 10,000 women taking older contraceptives.

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