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URMC / Patients & Families / Health Matters / June 2015 / Safety Check: Pregnancy and Antidepressant Drugs

Safety Check: Pregnancy and Antidepressant Drugs

 
Is it safe to take antidepressants when you’re pregnant? UR Medicine high-risk pregnancy expert Dr. Neil Seligman sorts through this issue, offering advice for women who suffer from depression and are pregnant or want to become pregnant.
 
pregnant woman
Depression and antidepressant use during pregnancy is exceedingly common and the safety debate surrounding this issue is often the topic of medical studies and news reports. Like any medical concern, the best approach is to talk with your provider. But, in general, there are some facts that may help guide you.
 
The drugs most typically prescribed for depression are in a category known as Selective Serotonin Reuptake Inhibitors, or SSRIs. The decision whether or not to continue taking an SSRI during pregnancy should be based on a woman’s need. If she was already on course to end the treatment—even if she wasn’t pregnant or planning a pregnancy—she can stop as planned. But if she still needs the medication to treat her depression, she should continue taking it. Counseling is also effective in treating depression and worth considering either in place of, or in addition to medication, if it’s available to her. 
 
With the possible exception of Paxil (paroxetine), there is no evidence that links SSRIs to birth defects. And if Paxil is the most effective option for her, a woman should be encouraged to continue it as needed during pregnancy. While some signs like jitteriness or a weak cry may be seen in some newborns whose mothers used SSRIs during pregnancy, they are harmless and short-lived. 
 
A recent study pointed to a link between antidepressants taken in late pregnancy and a higher risk for a newborn to have a potentially life-threatening breathing problem known as persistent pulmonary hypertension (PPHN). It’s important to look at this in light of the risk of PPHN in all newborns. In this study, the risk of PPHN in newborns was 0.34 percent for those born to women who took SSRIs, and 0.25 percent in newborns of women who didn’t. That means there is approximately 1 extra case of PPHN for every 1,000 women using SSRIs. If we judge these risks as unacceptable, it’s as if we are denying the fact that the consequences of untreated depression are more common and potentially more serious.
 
What’s Safe and What’s Not?
 
For a long time, the U.S. Food and Drug Administration Pregnancy Category* has been the “go to” source for drug safety information. In summary, they are: 
  • Category A or B: Known to be safe and includes medications like levothyroxine (thyroid hormone replacement), methyldopa (used for high blood pressure), insulin (treatment for diabetes), and amoxicillin (common antibiotic).
  • Category C: Includes most SSRIs and other medications that may carry risks but lack information because of limited testing in people. While drugs in this category undergo animal studies to help determine safety, they may lack rigorous well-controlled human studies because, for obvious safety reasons, such testing isn’t done in pregnant women. And while valuable information comes from animal studies, the studies and their results can differ from human trials.
  • Category D: Known to cause birth defects but, in some cases, the benefit may outweigh the risk. One example is Tegretol (carbamazepine), used to treat seizures. It’s been associated with a risk of birth defects like spina bifida (incomplete closure of the backbone), craniofacial defects (problems with the face, skull, or brain), congenital heart disease, and hypospadias (genital defect). Overall, the risk is low and women are often advised to continue these medications if there aren’t safer, equally effective options.
  • Category X: Known risks and almost never needed during pregnancy. They should be avoided except in rare circumstances. One example is Accutane, used to treat acne, which can interfere with normal development of multiple organs including the eyes, heart, and brain.
 
Medication use during pregnancy is complicated. Women and their providers should consider the reproductive safety of any drug before it’s prescribed. They might also consider a pre-conception consultation with a high-risk pregnancy specialist, to discuss medication risks and help them decide whether the best approach is to continue or change a medication, or if it should be stopped altogether. 
 
However, many pregnancies are unplanned. When a woman learns she’s pregnant, she should talk with a health provider right away, before stopping any medications. Stopping medications when a woman is already pregnant does not always remove the risk. For example, stopping a medication in the second trimester has essentially no benefit in preventing birth defects. The type of drug, the dose, and how and when it’s taken are all important considerations during pregnancy. 
 
 

*The FDA drug labeling is scheduled to change at the end of June and will include removal of the letter categories. We’ll update this post when the new information is available.

 
 
Neil Seligman, MD
 
 
Neil S. Seligman, M.D., is an assistant professor of Obstetrics and Gynecology in the Division of Maternal Fetal Medicine. He specializes in high-risk pregnancy care at UR Medicine’s Strong Memorial Hospital.
 
 
 

6/23/2015

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