Risk of Malformations

SSRIs and Cardiovascular Malformations: Another Look

Over the last few years, we have reported on several studies which have suggested an increased risk of certain types of cardiovascular malformations among children exposed to selective serotonin reuptake inhibitors (SSRIs) during pregnancy.  The first reports suggested a link between cardiac septal defects and exposure to paroxetine; subsequent studies have also shown elevated risks with the other SSRIIs. 

By |2015-08-10T14:03:04-04:00November 20th, 2012|Antidepressants, Pregnancy & Medications, Risk of Malformations|Comments Off on SSRIs and Cardiovascular Malformations: Another Look

More on Topiramate (Topamax) and Risk of Oral Clefts

Earlier this year we reported on a possible association between first trimester exposure to topiramate (Topamax) and increased risk of cleft lip and palate.  In a recent study published by the American Journal of Obstetrics and Gynecology, researches drew upon data from two birth defect databases to further delineate the risks associated with topiramate exposure.

By |2015-08-12T12:17:18-04:00August 13th, 2012|Anti-Epileptic Drugs, Mood Stabilizers, Pregnancy & Medications, Risk of Malformations|Comments Off on More on Topiramate (Topamax) and Risk of Oral Clefts

Outcomes of Children Exposed to Antiepileptic Drugs in Pregnancy: No Good News for Valproate

There have long been concerns regarding the use of the anticonvulsant valproate (Depakote) during pregnancy. First trimester use of valproate has been associated with a 3-5% risk of neural tube defects, as well as an increased risk of other malformations affecting the heart. In addition, recent reports have indicated that in utero exposure to valproate may also result in lower IQ.

By |2025-06-26T09:08:15-04:00June 26th, 2012|Anti-Epileptic Drugs, Mood Stabilizers, Outcomes, Pregnancy & Medications, Risk of Malformations|Comments Off on Outcomes of Children Exposed to Antiepileptic Drugs in Pregnancy: No Good News for Valproate

From the North American AED Pregnancy Registry: The Newer Anticonvulsants Appear to Be Safer

While it is well-established that several of the older anticonvulsants, including valproate (Depakote), carry a significant teratogenic risk, less is known about the reproductive safety of the newer antiepileptic drugs (AEDs). The North American AED Pregnancy Registry was established in 1997 for pregnant women in the United States and Canada at the Massachusetts General Hospital. The purpose of the registry is to obtain and publish information on the frequency of major malformations among infants whose mothers have taken one or more AEDs during pregnancy.

By |2025-06-26T09:08:16-04:00June 13th, 2012|Anti-Epileptic Drugs, Mood Stabilizers, Outcomes, Pregnancy & Medications, Risk of Malformations|Comments Off on From the North American AED Pregnancy Registry: The Newer Anticonvulsants Appear to Be Safer

The National Pregnancy Registry for Atypical Antipsychotics: Looking Ahead to 2012

We want to thank those of you who have continued to subscribe to our blog and who have visited our website. Some have written noting particular interest in the research conducted at the MGH Center for Women's Mental Health, including the National Pregnancy Registry for Atypical Antipsychotics.

By |2016-03-28T13:23:57-04:00February 9th, 2012|Antipsychotic Medications, Outcomes, Pregnancy & Medications, Risk of Malformations|Comments Off on The National Pregnancy Registry for Atypical Antipsychotics: Looking Ahead to 2012

Topiramate (Topamax) Associated with an Increased Risk of Oral Clefts

Topiramate (marketed as a Topamax), in addition to its use for the treatment of epilepsy, is now being prescribed to reproductive aged women for a broad spectrum of indications, including migraine headaches, weight control, and mood stabilization.  Limited information is available on its reproductive safety; however, the preliminary data we do have raises some concerns regarding the use of topiramate in pregnancy.

By |2015-08-12T16:57:19-04:00February 8th, 2012|Anti-Epileptic Drugs, Outcomes, Pregnancy & Medications, Risk of Malformations|Comments Off on Topiramate (Topamax) Associated with an Increased Risk of Oral Clefts

Valproic Acid and the Risk of Major Malformations

Previous studies have indicated that infants exposed to valproic acid in pregnancy are at increased risk for a range of malformations, including neural tube defects.  While these studies have shown an association between valproic acid and various malformations, they have been limited in their ability to quantify the risk of certain, less common malformations.  To do this, large population-based case–control studies are more appropriate.

By |2015-08-12T16:43:09-04:00June 14th, 2010|Anti-Epileptic Drugs, Mood Stabilizers, Outcomes, Pregnancy & Medications, Risk of Malformations|Comments Off on Valproic Acid and the Risk of Major Malformations

St. John’s Wort: Is it Safe for Pregnancy?

St. John's wort (Hypericum perforatum) is an herbal preparation which has been shown, in some studies, to be effective for the treatment of mild to moderate depressive symptoms. St. John's wort is now one of the most commonly used herbal products in the United States and is widely used in Europe.

By |2015-08-11T14:14:20-04:00August 5th, 2008|Antidepressants, Depressive Disorders, Pregnancy & Medications, Risk of Malformations|Comments Off on St. John’s Wort: Is it Safe for 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.

By |2015-08-11T13:41:57-04:00June 10th, 2008|Child Outcomes, Neonatal Symptoms, Pregnancy & Medications, Risk of Malformations|Comments Off on FDA Proposes Major Revision of Prescription Drug Labeling

Melatonin in Pregnancy: Is it Safe?

Many women experience some degree of sleep disturbance during pregnancy. For a significant number of women, the sleep disruption may be so severe as to require some type of intervention. In a previous post, we discussed the use of different types of medications to treat insomnia during pregnancy. While these drugs are highly effective, many women with sleep problems inquire about the use of "natural" agents, such as melatonin, during pregnancy.

By |2017-04-07T09:30:08-04:00May 30th, 2008|Alternative & Complementary, Child Outcomes, Outcomes, Pregnancy & Medications, Risk of Malformations, Sleep Medications|Comments Off on Melatonin in Pregnancy: Is it Safe?
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