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Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles.
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
Competing interests:
Dr. Kruszewski does not have any current business or financial arrangements with any pharmaceutical company. Prior to 2000, Dr. Kruszewski participated on the speaker’s bureaus of the following companies: Pfizer, Inc., GlaxoSmithKline, Janssen (Johnson and Johnson), AstraZeneca, Wallace Labs, Eli Lilly, GE-Amersham Biosciences; and previously Served on an Eli Lilly Northeast Advisory Panel (1998.)
There is still limited knowledge on the risk of fetal abnormality
associated with the use of antidepressants. Afterall major malformations
occur spontenously in up to 2% of cases. if possible pre pregnancy
planning however a significant number may not be able to do this.
therefore the risk of relapse during pregnancy or postnatal depression and
the consequences on both the mother and child may outweigh the benefits.
Ultimately the choice remains with the mother.
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
Competing interests:
Dr. Kruszewski does not have any current business or financial arrangements with any pharmaceutical company. Prior to 2000, Dr. Kruszewski participated on the speaker’s bureaus of the following companies: Pfizer, Inc., GlaxoSmithKline, Janssen (Johnson and Johnson), AstraZeneca, Wallace Labs, Eli Lilly, GE-Amersham Biosciences; and previously Served on an Eli Lilly Northeast Advisory Panel (1998.)
Competing interests: No competing interests