Anti-Depressants and Pregnancy: A Mixed Bag of Warnings and Potential Risks

Anti-Depressants and Pregnancy: A Mixed Bag of Warnings and Potential Risks

Posted By The Maher Law Firm || 3-Mar-2014

Incompatible

Recently, we blogged about a new meta-analysis that found an increased risk of heart defects in infants born to women who use anti-depressants known as SSRI's late in pregnancy. In fact, some anti-depressants can cause a range of birth defects if taken by women during pregnancy, though the risks aren't necessarily reflected by the classification by the Food and Drug Administration (FDA).

The Office on Women's Health in the U.S. Department of Health and Human Services estimates 13 percent of pregnant women and new mothers suffer from depression. This is significant because these women often seek medical help for their feelings of hopelessness and despair. That help often comes in the form of prescription drugs like selective serotonin reuptake inhibitors, or SSRIs.

These anti-depressants carry risks specific to pregnant women and their unborn children. Though they are all part of the same drug class, SSRIs are not all classified the same and do carry risks of birth defects.

SSRI Risks Vary By Drug

A 2009 Danish study published in the British Medical Journal found the use of Zoloft and Celexa early in pregnancy slightly increased the risk of a heart defect in infants. The same association was not seen in other SSRIs, including Prozac and Paxil.

The most recent meta-analysis, for instance, found a "statistically significant" association between pulmonary hypertension in newborns and SSRI usage late in pregnancy.

In 2005, the Food and Drug Administration found the risks associated with Paxil to be so significant that they changed the classification of the drug as to fetal risk. Two separate studies at that time found that women taking Paxil during the first trimester to be one-and-a-half to two times more likely to deliver a baby with a heart defect compared to women not on antidepressants or even those on other antidepressants.

The FDA changed Paxil from a pregnancy category C drug to a pregnancy category D drug. These categories guide doctors as to which drugs carry risks of birth defects and may prescribed for pregnant women. In fact, drugs in either pregnancy category C and category D can cause birth defect. There is just more evidence of human fetal risk of birth defects based on patient experience or human studies in category D drugs.

Drugs in either category C or category D may be prescribed to pregnant women if the benefits outweigh the risks.

Category X drugs, at the far end of the spectrum, are those that should never be prescribed to pregnant women.

The problem with Paxil's label change is that it came late-after pregnant women had already taken the drug and given birth to children with birth defects. They didn't receive the proper warnings. Drug makers have a legal responsibility to make and market drugs that are safe when used as directed and to provide adequate warning of known dangers.

After Paxil was reclassified as a category D drug, doctors would look for an alternative category C SSRI drug to prescribe to patients who were pregnant.

Different Drugs = Different Risks

Zoloft, Paxil, Prozac, and Celexa are all SSRIs. They regulate the uptake of serotonin, a neurotransmitter. But, they don't all have the same formulations or effects. So, while they may be in the same class of drugs, they are very different.

Drug makers should know the risks of their products and should share that information with doctors and patients. Doctors then are able to help patients choose the right prescription regimen given their symptoms and the risks and benefits of the many drug choices. When any breakdown in this line of communication occurs, it's the patient and her unborn baby who stand to suffer.

Dangerous drugs are the responsibility of the manufacturers that develop and market them. Ultimately, the patients stand to lose the most when the risks are not made abundantly clear.

Categories: Dangerous Drugs
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