FDA’s New Labeling Rule: Clinical Implications
The following post was first published in OB/GYN News.
Avoid Valproic Acid in Women of Reproductive Age
The European Medicine Agency (EMA)'s Pharmacovigilance and Risk Assessment Committee recently recommended strengthening the restrictions on the use of valproic acid in women of reproductive age. Over the last few years, we have seen a host of articles documenting the deleterious effects of valproic acid on the developing fetus:
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.
Medications and Pregnancy: A Focus on the Pharmacokinetics
We have an abundance of articles which address the impact of psychotropic medications on pregnancy. Much less research, however, has focused on how pregnancy may affect how these medications work. Physiologic changes take place during [...]
SSRI Exposure during Pregnancy: What’s Enough Data?
The following post was first published in OB/GYN News.
Anti-Epileptic Drugs and Risk of Miscarriage
Do anti-epileptic drugs increase the risk for miscarriage and/or stillbirth? Many reports have demonstrated an association between the use of antiepileptic drugs during pregnancy and increased risk of congenital malformations and pregnancy complications, including pre-eclampsia, [...]
Prenatal Valproate Exposure and Risk of Autism Spectrum Disorders
Autism spectrum disorders (ASDs), which include childhood autism, autistic disorder, Asperger syndrome, atypical autism, and other pervasive developmental disorders, are characterized by social and communication difficulties and by stereotyped or repetitive behaviors and interests. It [...]
Women Who Stop SSRIs Prior to Pregnancy Have Same Risk of Miscarriage as Women who elect to Remain on SSRI Antidepressants
Some, but not all, studies have demonstrated an increased risk of miscarriage among women who take antidepressants. However, it has been difficult to determine whether this increased risk was related to exposure to the medication [...]
Wellbutrin (Bupropion) Exposure and Risk of Cardiac Malformations
Bupropion is commonly used to treat depression, and is also prescribed to support smoking cessation. Early data on bupropion-exposure during pregnancy raised concern for a possible increase in risk of malformations of the heart and large blood vessels in bupropion-exposed infants. Subsequent data from bupropion pregnancy registries has been reassuring, however, and do not demonstrate an overall increase in risk of cardiac defects following first trimester bupropion exposure. Although the overall risk of cardiac defects was not increased, the distribution of specific defects in these registries was unexpected in some ways. For example, the GlaxoSmithKline Bupropion Pregnancy Registry included two cases of coarctation of the aorta out of the 675 bupropion-exposed infants, compared to the rate of 6 cases per 10,000 births in the general population.
New Data on Anxiety Medications and Pregnancy
Benzodiazepines and non-benzodiazepine hypnotics are commonly used during pregnancy. However, there data regarding the reproductive safety of these agents has been somewhat mixed. Although initial reports suggested that there may be an increased risk of cleft lip and palate, more recent reports have shown no association between exposure to benzodiazepines and risk for cleft lip or palate. A new study shows no increase in the overall risk of malformations among children exposed to benzodiazepines.