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.

Bipolar Disorder and Pregnancy: Should Medications Be Discontinued?

As many of the traditional mood stabilizers used to treat bipolar disorder, including lithium and valproic acid, carry some teratogenic risk and the reproductive safety of other medications, including the atypical antipsychotic agents, has not been well-characterized, many women with bipolar disorder decide to discontinue their treatment during pregnancy. A new study from Dr. Adele Viguera and her colleagues at the Massachusetts General Hospital and the Emory University School of Medicine helps to better define the risks associated with discontinuing treatment during pregnancy.

Medication Changes During Pregnancy

At our clinic we have the opportunity to see patients at various stages of pregnancy. When we evaluate a patient while she is still in the planning stages, we may recommend changing medications to those that have a better studied safety profile during pregnancy and see how she does on those medications prior to conception. If that same patient came into our clinic for an evaluation, but was already pregnant, we may make different recommendations than if she was in the planning stages.

Can Paxil (Paroxetine) Be Used While Breastfeeding?

All medications are secreted into the breast milk, although concentrations appear to vary. There is a fair amount of information on the use of Paxil (paroxetine) in nursing women. While Paxil may be detected in the breast milk, there have been no reports of adverse events in the nursing infant. The only situation where one may want to avoid breastfeeding is when the baby is premature or has signs of hepatic immaturity, which may make it more difficult for the infant to metabolize the medication to which he or she is exposed. Premature babies are also probably more vulnerable to the toxic effects of these medications.