Study warns of birth defects from use of paroxetine during pregnancy

ealth Ministry doesn’t change policy that it is ‘safe, but will monitor’

January 7, 2016 05:15
2 minute read.
pregnant woman

A pregnant woman. (photo credit: REUTERS)


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A widely used antidepressant drug has been found by Canadian researchers in a meta-analysis to be linked with an increased risk of birth defects when taken in early pregnancy. The findings have just been published in the British Journal of Clinical Pharmacology.

Known generically as paroxetine and commercially as Paxil and Seroxat, the drug is prescribed to treat depression, obsessive-compulsive disorder, anxiety and post-traumatic stress disorder. Paroxetine is one of the selective serotonin reuptake inhibitor (SSRI)-type drugs for psychiatric problems.

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Asked by The Jerusalem Post to comment, the Health Ministry consulted with its pharmaceutical chief Dr. Eyal Schwartzberg and Prof. Mati Berkowitz, chairman of the Israel Ambulatory Pediatric Association and head of the department of pharmacology and toxicology at Assaf Harofeh Medical Center in Tzrifin.

They said that many articles on SSRIs and pregnancy have been published.

“In general it’s very important to treat anxiety and depression during gestation. SSRIs are considered safe during pregnancy. One must always consider a woman’s emotional condition.

Unnecessary halting the use of SSRIs can lead to post-natal depression and even worse. But at the same time,” they commented, “women prescribed these drugs have to be followed up by her doctor. This study does not change our policy.”

The ministry, however, said it and other health authorities “continue at all times to follow side effects, and this subject too will be raised for discussion during their routine work.”

Prof. Anick Bérard and colleagues at CHU Sainte-Justine and the University of Montreal conducted a literature review and meta-analysis of all relevant studies published from 1966 to 2015. They uncovered 23 eligible studies.

Using paroxetine during the first trimester of pregnancy may increase newborns’ risk of congenital malformations and cardiac malformations, they concluded.

Up to a fifth of women of childbearing age experience depressive symptoms that often lead to mild to moderate depression, and prescriptions for antidepressants during pregnancy have increased in recent years, they wrote in the medical journal.

The most common drugs for treating depression in pregnant women are SSRIs, and up until 2005, one drug in that class – paroxetine – was considered to be safe for use during pregnancy.

However, a small unpublished study conducted by the manufacturer suggested an increased risk of cardiac malformations in infants exposed to paroxetine before birth. Subsequent studies using various study designs in different populations across Europe and North America generated conflicting results in terms of statistical significance, although a trend remained toward an increased risk.

Compared with no use of paroxetine, first trimester use of paroxetine was associated with a 23 percent increased risk of any major congenital malformations and a 28% increased risk of major cardiac malformations in newborns. The investigators noted that the baseline risk of major malformations is 3% and of cardiac malformations 1%, however, any increase in risk is significant, especially when considering that the benefit of using SSRIs during pregnancy, when changes in metabolism cause the drugs to be cleared from the body at a faster rate.

“Given that the benefits of antidepressants overall, and SSRIs including paroxetine specifically, during pregnancy is questionable at best, any increase in risk, small or large, is too high,” the researchers wrote. “Indeed, the risk/benefit ratio suggests non-use in women with mild to moderately depressive symptoms, which is 85% of pregnant women with depressive symptoms. Therefore, planning of pregnancy is essential, and valid treatment options such as psychotherapy or exercise regimens are warranted in this special population.”

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