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David Baxter

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SSRIs in Pregnancy Not Associated With Cardiac or Pulmonary Problems
May 23, 2007

SAN DIEGO -- In utero exposure to selective serotonin reuptake inhibitors was not significantly associated with the risk for cardiac malformations or persistent pulmonary hypertension.

In a retrospective review of records of more than 25,000 pregnant women treated at the Mayo Clinic in Rochester, Minn., from 1993 through 2005, there was no association between the mothers' SSRI use during pregnancy and the occurrence of congenital heart disease, ventricular septal defects, or persistent pulmonary hypertension in their children, reported Christina L. Wichman, D.O., and colleagues at the American Psychiatric Association meeting here.

"Recent data indicates that approximately 10% to 15% of women will have depression at any point during pregnancy or the post-partum period," they wrote. Selective serotonin reuptake inhibitors are the first line pharmacotherapy to treat depression, they noted, but "inconsistent data has been reported regarding the safety of SSRIs in pregnancy."

In a separate presentation, the same authors noted that the percentage of pregnant women in their practice who used SSRIs rose from less than 1% in 1993 to 5% in 2005. They speculated that the increase is because of an increasing perception among patients and physicians that the drugs are safe to use during pregnancy.

Although many studies have found no association between SSRIs in pregnancy and the risk for major birth defects above a baseline of 1% to 3%, several recent studies have suggested that paroxetine (Paxil) use in the first trimester may be associated with ventricular septal defects, and that newborns with late-pregnancy exposure to SSRIs are at increased risk for persistent pulmonary hypertension, the authors noted.

To see if they could find evidence of an association, the authors conducted a retrospective chart review of all pregnant women presenting at the Mayo Clinic from 1993 through 2005.

They identified a total of 25,214 deliveries during that period, and 745 mothers who had been treated with SSRIs during their pregnancies. The authors also reviewed the medical charts of the babies exposed to SSRIs during pregnancy to review fetal outcomes.

They found that among the 208 infants with congenital heart disease, only two had been exposed to SSRIs, and that there was no statistical association with SSRI use and congenital heart disease.

In all, 153 of the women had taken paroxetine during pregnancy, and none of their children were born with a ventricular septal defect. In addition, among 16 infants diagnosed with persistent pulmonary hypertension, none had been exposed to SSRIs in utero.

"Our data supports the safety of SSRIs during pregnancy in regards to cardiac malformations, including ventricular septal defects, and persistent pulmonary hypertension," the authors wrote.

They noted that their study was limited by the retrospective design, reliance on medical records rather than patient interviews, and the difficulty in diagnosing malformations such as ventricular septal defects in infancy.

The researchers recommended that women who are considering SSRI use during pregnancy be given informed consent with the discussion focusing on the risks of depression in pregnancy, non-drug treatment options, possible risks of SSRI exposure to the fetus, potential adverse effects on the mother, and the benefits of SSRI use in treatment of depression.

Primary source: American Psychiatric Association 2007 Annual Meeting

Source references:
Wichman CL et al. "Selective Serotonin Reuptake Inhibitor Use in Pregnancy and Fetal Outcomes." Abstract NR38, presented May 21.

Wichman CL et al. "Prevalence of Serotonin Specific Reuptake Inhibitor (SSRI) Use in Pregnant Women." Abstract NR41 presented May 21.
 

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They noted that their study was limited by the retrospective design, reliance on medical records rather than patient interviews, and the difficulty in diagnosing malformations such as ventricular septal defects in infancy.

How important is this limitation on the reliability of the conclusions of this retrospective study?

Can pregnant women feel totally comfortable to use SSRI's (except for perhaps Paxil) to treat their depression, and and not be concerned for the baby?
 

David Baxter

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How important is this limitation on the reliability of the conclusions of this retrospective study?

There are some limitations in retropsective studies, not the least of which is the accuracy of data recorded. In a prospective study, the researchers are specifically recording data and looking for evidence of certain risks or sumptoms, so they will ensure that a record is made of whether or not the condition or symptom appears for every subject. In a retrospective study, there is the possibility that relevant data was not recorded in the charts for all patients, i.e., the absence of a note cannot be taken as conclusive evidence that the symptom or condition was not there.

Can pregnant women feel totally comfortable to use SSRI's (except for perhaps Paxil) to treat their depression, and and not be concerned for the baby?

I don't think there is any doubt that avoidance of all unnecessary medications, prescription or over-the-counter, is the recommendation of choice for pregnancy. However, one must weigh this against the possibility that untreated depression or anxiety in the mother can also influence fetal development and may present significant risks for both mother and child.

Also note that this study only reports on the association between SSRIs and two conditions or symptoms. There may be other symptoms or conditions that were not examined in this study.

As always, the best advice is to consult your own doctor who is familiar with your medical-psychiatric history.

why not Paxil?

Because in previous studies, there were concerns about the effect of Paxil in particular on fetal development:

Although many studies have found no association between SSRIs in pregnancy and the risk for major birth defects above a baseline of 1% to 3%, several recent studies have suggested that paroxetine (Paxil) use in the first trimester may be associated with ventricular septal defects, and that newborns with late-pregnancy exposure to SSRIs are at increased risk for persistent pulmonary hypertension, the authors noted.

On the other hand, this particular study could not confirm that.
 

Christina

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geesh... I really don't think that I can not take Paxil... I'm not pregnant but hopefully soon..... I know that it will destroy me if I cause any harm to my child.. but on the other hand, I have to think about me to.. I hope that didn't sound terrible.. I am not very good at expressing things sometimes
 

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You may not need to discontinue Paxil, Christina, or your doctor might recommend switching to a different SSRI. Talk to your doctor about this if you are planning a pregnancy.
 

Christina

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I have talked to my doctor and she seems to be o.k with me taking the Paxil...I would like to switch to effexor but she thinks that paxil is better than effexor if I want to become pregnant..but then again she also thinks that smoking pot in pregnancy is not all that bad..so i don't know..I feel I need to research more before I decide for myself..I do hope that when/if I do get pregnant that I will be able to lower my dose alot..
 

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If you have any doubts about the advice your doctor is giving you, there's nothing wrong with seeking a second opinion. Perhaps you could ask your doctor for a referral to an obstetrician or similar specialist. This is obviously not my specialty and I wouldn't presume to comment on what your doctor is advising.
 

Christina

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thank you yes I am thinking about a second opinion...I have checked also with my in vitro doctor..and he seems to think its ok as well...maybe its just me I dont know
 

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Christina,

A Google search on the terms Paxil Pregnancy returns articles on the subject of concerns about the use of Paxil (paroxetine) in pregnancy.

This information needs to be weighed against the advice of a physician whose competence you regard as being up to date on the subject.

Decisions such as these should be made on a benefits vs risks basis, and being informed on the subject provides you with the knowledge you need to discuss the subject with your doctor.

My personal view is that we should be partners in our healthcare with our doctors, and in order to be a competent partner, we need to be informed.
 

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