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Re: SSRI Informed Consent requires Full and Complete Disclosure

Dobson’s article on the maternal use of SSRIs and the subsequent risk of congenital malformations (1) commented on the striking evidence compiled by Wogelius et al in their article published in Epidemiology. (2) The adjusted risk for congenital injuries was 1.34(95% confidence interval= 1.00-1.79) for women who took SSRIs at anytime in their pregnancy. For women who took SSRIs during their second or third month, the adjusted relative risk was 1.84(95% confidence interval = 1.25 – 2.71). Both of those adjusted relative risks represent higher rates of injury (4.9% and 6.8%, respectively) than the background spontaneous rate of malformations noted by Dr. Olaloko in his response. (3)

Data regarding SSRI-induced adverse effects must not be hidden, either by drug manufacturers (4) or academicians who study neonatal injury (5, 6). The positive and negative data regarding potential injury must be readily available and communicated in terms that are understandable. (7)

While every psychiatrist and obstetrician-gynecologist must be mindful of the serious consequences of depression in the peri-natal period, women must be provided with balanced information in order to make the determination of whether to risk the use of antidepressant medication. That full and accurate disclosure is the basis of informed consent. Without the carefully and fully articulated provision of positive and negative data that underscores an assessment of a risk-to-benefit decision, the mother’s choice is not informed. Instead, it becomes an arbitrary declaration based upon previous, often unrelated, beliefs and assumptions.

The inability to provide informed consent, whether on the basis of suppressed or selected release of clinical data, unbalanced presentations to the patient, misinformed physicians, and/or conflicts-of-interest that unintentionally or otherwise misrepresent the available scientific findings, is a tragic disservice to mothers and their newborns.

Stefan P. Kruszewski, M.D. Harrisburg, Pennsylvania USA

(1) Dobson R. SSRI use during pregnancy is associated with fetal abnormalities BMJ 2006; 333: 824-d

(2) Wogelius P et al. Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations. Epidemiology. 2006; 17(6): 701-704.

(3) Olaloko, O. It is a matter of risk benefit ratio; response to: SSRI use during pregnancy is associated with fetal abnormalities BMJ 2006; 333: 824-d

(4) Pringle E. Glaxo get Hit with another Paxil Birth Defects Lawsuit. 17 October 2006. Accessed on 10.28.06 at ttp://www.lawyersandsettlements.com/articles/paxil-glaxo-lawsuits.html

(5) Ferriero DM. Neonatal Brain Injury. N Engl J Med 2005; 532(8): 839

(6) Kruszewski SP. Neonatal Brain Injury. N Engl J Med 2005; 532(8): 839

(7) MedWatch, 08 December 2005. The FDA Safety Information and Adverse Event Reporting Program. Accessed at http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil3