FDA’s New Labeling Rule: Clinical Implications
The following post was first published in OB/GYN News.
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.
New FDA Pregnancy Category Labeling: Still Waiting…
This is a very nice article published by the College of Psychiatric and Neurologic Pharmacists discussing the limitations of the current FDA pregnancy category labeling system.
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.
In Utero Exposure to Antipsychotics
May 2011, ObGyn News, Lee S. Cohen, MD
New FDA Warning on the Use of Antipsychotic Medications in Pregnancy
On February 22, 2011, the U.S. Food and Drug Administration (FDA) informed healthcare professionals that drug labels for the entire class of antipsychotic drugs have been updated to include warnings regarding the use of antipsychotic drugs during pregnancy. The new drug labels now contain more details on the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns exposed to these drugs during the third trimester of pregnancy.
FDA Proposes Major Revision of Prescription Drug Labeling
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. As it stands, the current system used by the FDA classifies the reproductive safety of medications using five risk categories (A, B, C, D and X) based on data derived from human and animal studies. While widely used to make decisions regarding the use of medications during pregnancy, many have criticized this system of classification, indicating that this type of drug labeling is often not helpful and, even worse, may be misleading.
Recent Antidepressant Label Changes
In October, the Food and Drug Administration (FDA) ordered drug manufacturers to include warnings in the packaging inserts regarding the use of certain antidepressants, including the selective serotonin reuptake inhibitors (SSRIs) and venlafaxine (Effexor), during pregnancy. The labels now describe a spectrum of adverse events in newborns exposed to these drugs late in the third trimester, including jitteriness, irritability, hypoglycemia (low blood sugar), feeding difficulties, respiratory distress, abnormal muscle tone, and constant crying. Complications requiring “prolonged hospitalization, respiratory support and tube feeding” are also mentioned.