BROKEN HEARTS: SSRIS IN PREGNANCY
Derelie Mangin
The approach to prescribing in general is one of balancing the risks and benefits ofa drug. Early drug disasters such as thalidomide use in pregnancy heightened theawareness of the unknown risks of drug use in pregnancy and resulted in policychange around drug use in general and in pregnancy in particular. In pregnancy
because fetal malformations have such potentially devastating and lifelong
consequences for parents and child, this assessment of the risks and benefits of adrug took an even more cautious approach. This applies particularly in the firsttrimester of pregnancy when organ development is occurring and adverse effects
can be most serious – resulting in loss of the pregnancy or serious congenital
malformations.
The evidence from both animal and epidemiological studies indicates that SSRI
use in the first trimester of pregnancy increases the risk of birth defects, inparticular it doubles the risk of heart defects. In addition use through pregnancy
is clearly associated with a range of other dangers including premature birth, aneonatal withdrawal syndromes, pulmonary hypertension in the newborn andmiscarriage. The effects on later child brain development are unknown.
Compounding this, the withdrawal symptoms on stopping SSRIs make it difficult
to stop an SSRI in time to avoid the dangers of birth defects once a woman
discovers she is pregnant.
The divide between the scientific and the corporate response to drug safetyissues is illustrated by what happened after the early signals of potential
teratogenicity in Paxil. Rather than cautioning about the potential harms oftreatment, the company emphasized instead the risks of untreated depression.
The marketing campaign aimed to “make Paxil the drug of choice for women”.

There were two key elements to the GSK marketing campaign; direct toconsumer advertising aimed to drive women in the reproductive years tophysicians to request Paxil for their treatment, and a sophisticated multifaceted
marketing campaign to physicians with the aim of increasing prescribing of Paxil
to women for a range of situations – depression, anxiety, premenstrual
dysphoric disorder, social anxiety disorder and during pregnancy. Itoveremphasized both the extent of the problem of depression in pregnancy andthe usefulness of Paxil in pregnancy and lactation. Paxil was promoted as being
safe in pregnancy when this was not supported by scientific knowledge. Whatwas known about it indicated that there were risks to use. The promotion tophysicians was highly misleading around safety in pregnancy given the state ofscientific knowledge at the time. This has been made even clearer by what hascome to light since and exposed unborn children to unreasonable danger.
Misleading information undermines the ability of the physicians to act as alearned intermediary between scientific knowledge and the patient. Whenmanipulation of information both to physician and consumer occur, theprocesses by which a patient might make a decision on the risk benefit balanceof a medication are compromised. This raises ethical issues around our ideas ofautonomous decision making and informed choice for patients in our current
system of medical care.