PUBLIC HEALTH ADVISORY: Continuing Antidepressants During Pregnancy May Help Mother, Harm Baby: A Medical Dilemma

DO NOT STOP ANY ANTIDEPRESSANT MEDICATION WITHOUT FIRST CONSULTING YOUR PHYSICIAN

Women who are pregnant and taking certain antidepressants take note: a recent study finds that you are more likely to have a recurrence of depression if you stop treatment during pregnancy, but another recent study suggests that taking certain antidepressants may harm your baby.

The Food and Drug Administration (FDA) alerted consumers and health professionals on July 19 about the results of studies, which included women treated with the antidepressants selective serotonin reuptake inhibitors (SSRIs) and, in a few cases, selective serotonin/norepinephrine reuptake inhibitors (SNRIs).  

SSRI antidepressants currently available in the United States alone or in combination with another drug are citalopram (CELEXA), escitalopram (LEXAPRO), fluoxetine (PROZAC, SARAFEM), fluoxetine with olanzapine (SYMBYAX), fluvoxamine (LUVOX), paroxetine (PAXIL) and sertraline (ZOLOFT). Two SNRI antidepressants — duloxetine (CYMBALTA) and venlafaxine (EFFEXOR) — are on the market in the United States.

The first study cited by the FDA found that women who stopped their SSRI antidepressants were five times more likely to have a recurrence of depression than women who continued antidepressant treatment while pregnant.  

This study was published February 1 in theJournal of the American Medical Association and was funded by the National Institute of Mental Health (NIMH), a part of the National Institutes of Health. The NIMH had no part in the design and conduct of the study, or in the collection, analysis, interpretation of the data, nor in the preparation, review or approval of the final published manuscript.

Two of the 13 authors reported financial ties to drug companies producing antidepressants. However, according to the July 11 Wall Street Journal, most of the 13 authors of this study are paid speakers or consultants hired by drug companies that make antidepressants.

The Wall Street Journal article says that the study’s lead author, Dr. Lee S. Cohen, a longtime consultant to antidepressant makers, and some of his coauthors have hit the lecture circuit, touting their findings. At the same time, these researchers have been spotlighting flaws in other recent studies (see below) that have found increased risks to babies born to mothers who use antidepressants during pregnancy.

The companies making antidepressants would obviously benefit financially if women did not stop taking antidepressants during pregnancy. This potential conflict of interests raises questions about the accuracy of the first study and the authors’ criticisms of the studies concerning risks to babies.  

The second study, published in the February 9 issue of the New England Journal of Medicine, suggests that a health condition known as persistent pulmonary hypertension (PPHN) is six times more likely in babies whose mothers took SSRI antidepressants after the 20th week of pregnancy compared to babies whose mothers did not take antidepressants.

PPHN is a life-threatening lung condition that can be diagnosed after a baby is born. Babies born with PPHN have high pressure in the blood vessels of their lungs and are not able to get enough oxygen into their bloodstreams.

About one to two babies per 1,000 births in the United Statesdevelop PPHN, and they often need intensive medical care. In contrast, six to 12 cases of PPHN develop per 1,000 births in mothers using antidepressants during pregnancy — a risk of about 1.2 percent, which is approximately six times higher than in women not using antidepressants during pregnancy, according to the study. This study was too small to compare the risk of one antidepressant to another.

The study was supported by a grant from the National Heart, Lung and Blood Institute, the National Center for Birth Defects Research and Prevention and the Massachusetts Department of Public Health. Five of the seven authors of this study reported financial arrangements with drug companies.  

Other problems

The FDA had previously alerted the public to some other problems identified in babies whose mothers used antidepressants during pregnancy.

The FDA announced that the professional product label, or package insert, for the SNRI antidepressant venlafaxine was changed on June 3, 2004, to say that babies of mothers who used the drug in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support and tube feeding.

In addition, the FDA notified healthcare professionals on September 27, 2005, that the professional product labeling, or package insert, for paroxetine was amended to warn of major congenital malformations (birth defects), primarily heart malformations, in children born to mothers taking the drug during their first trimester of pregnancy.

This warning was based on a study that the FDA had asked GlaxoSmithKline, the manufacturer of paroxetine, to conduct. The results suggested a more than two-fold increase in the risk of major congenital malformations when paroxetine was taken compared to other antidepressants. This study has not been published, but a more complete description of the study can be found on GlaxoSmithKline’s Web site at http://ctr.gsk.co.uk/Summary/paroxetine/epip083.pdf (see Worst Pills, Best Pills News December 2005 ).

In the October 2004 issue of Worst Pills, Best Pills News, Public Citizen alerted readers that the Canadian equivalent of the FDA, Health Canada, issued a public advisory on August 9, 2004, warning that newborns may be adversely affected when their mothers take SSRIs, SNRIs or other newer antidepressants during the third trimester of pregnancy. The symptoms reported in these babies included either feeding or breathing difficulties or both, seizures, muscle rigidity, jitteriness and constant crying.

Depression in pregnant women is growing, as is the list of potential harms to newborns whose mothers are treated with antidepressants. This makes the decision to take, or not to take, one of these drugs during pregnancy much more difficult for women and their physicians.

What You Can Do

If you are pregnant or thinking about becoming pregnant, DO NOT stop taking any antidepressant without first consulting your physician.

No blanket recommendation can be made about using, or not using, antidepressants during pregnancy. You and the physician treating your depression must carefully consider and discuss together the potential benefits and harms of treatment with antidepressants during pregnancy.