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Ms. Einarson Replies

To the Editor: We thank Drs. Mintzes and Jureidini for their interest in our study. They felt that the statement "appropriate treatment of depression during pregnancy is essential and if this includes taking paroxetine, this information should reassure women and their health care providers" was an endorsement, which is at odds with regulatory warnings. This is an incorrect assumption because we do not endorse any drugs used in pregnancy; we only examine safety. Critically, the regulatory warnings they reference (1, 2) are based on the results of preliminary findings, which have not been updated because new data, including our study, has been published, refuting these early findings (3, 4).

The design employed in our study is one that has been used over many years to examine the safety of numerous drugs in pregnancy (5). It is widely considered to be an optimal design in the absence of randomized control trials that cannot be ethically conducted among pregnant women. The study design was discussed in detail in our article, documenting that the maternal characteristics were similar in both the exposed group and the unexposed comparison group. We also detailed the limitations in the discussion section. The data Drs. Mintzes and Jureidini state were missing would have only been available if our study had been a randomized control trial. The results of the previously published data were included—since we documented that there was a 1.5% increased risk for heart defects as opposed to approximately 1% in the general population—both in the abstract and in the body of the article. As we discussed, 50% of all pregnancies are unplanned, and all the women who participated in our study were receiving paroxetine prior to becoming pregnant. We cited the JAMA study conducted by Cohen et al., since it illustrated the importance of treating depression during pregnancy when appropriate.

The treatment of depression during pregnancy with antidepressants is a complicated decision for both the physician and the pregnant patient. Being "on the safe side" by not using these drugs during pregnancy because of unproven potential harm is not always an option, especially if a woman is already pregnant and receiving an antidepressant. Each case requires individual evaluation, and a risk/benefit assessment must be conducted in order to serve the best interest of both the pregnant mother and her unborn child.

Footnotes

This letter (doi: 10.1176/appi.ajp.2008.08040573r) was accepted for publication in August 2008.

Errors in the Journal"s editorial office resulted in the disclosures of Ms. Einarson and her co-authors not accompanying the original article and so they are presented here: Dr. Koren and Ms. Einarson have received research support from Janssen-Ortho and Wyeth. Dr. Koren has received research support from Apotex, Duchesnay, Novartis, and Pfizer. Ms. Einarson has received unrestricted research grants from GlaxoSmithKline for studying ondansetron in pregnancy and from Organon for studying mirtazapine in pregnancy. Dr. Einarson has received research support from Bristol-Myers Squibb, Eli Lilly, Janssen-Ortho, Lundbeck, Novo Nordisk, and Organon. The remaining authors report no competing interests.

References

1. GlaxoSmithKline: Epidemiology Study: Paroxetine in the First Trimester and the Prevalence of Congenital Malformations, EPI40404
2. US Food and Drug Administration: FDA Advising of Risk of Birth Defects with Paxil, P05-97. Rockville, Md, FDA News, 2005. http://69.20.19.211/bbs/topics/NEWS/2005/NEW01270.html
3. Louik C, Lin AE, Werler MM, Hernández-Díaz S, Mitchell AA: First-trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects. N Engl J Med 2007; 356:2675–2683[Abstract/Free Full Text]
4. Ramos E, St-André M, Rey E, Oraichi D, Bérard A: Duration of antidepressant use during pregnancy and risk of major congenital malformations. Br J Psychiatry 2008; 192:344–350[Abstract/Free Full Text]
5. Chambers CD, Braddock SR, Briggs GG, Einarson A, Johnson YR, Miller RK, Polifka JE, Robinson LK, Stepanuk K, Lyons Jones K: Postmarketing surveillance for human teratogenicity: a model approach. Teratology 2001; 64:252–261[CrossRef][Medline]

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