Paroxetine in early pregnancy once again linked to birth defects

A pharmacy employee looks for medication as she works to fill a prescription while working at a pharmacy in New York December 23, 2009. REUTERS/Lucas Jackson (UNITED STATES - Tags: HEALTH POLITICS) - RTR28BCM

Women who take the antidepressant paroxetine (Paxil, Seroxat) early in pregnancy may be more likely to have babies with birth defects, a review of previous research suggests.

While the absolute risk of birth defects remains small at 1 percent to 3 percent across all pregnancies, researchers found that using paroxetine during the first trimester was linked to a 23 percent increase in risk for major congenital malformations and a 28 percent higher risk of heart defects.

The study doesn't prove that paroxetine causes birth defects, the study team notes in the British Journal of Clinical Pharmacology, but the analysis is important because the drug is widely prescribed and as many as one fifth of women of child-bearing age may experience symptoms of depression.

"In the majority of cases - mild to moderate depression - psychotherapy and exercise regimens are valid treatment options," said lead study author Anick Berard of CHU Sainte-Justine and the University of Montreal.

Left untreated, depression during pregnancy is associated with underweight babies who are more likely to wind up in neonatal intensive care, previous research has found. Pregnant women with uncontrolled depression may not eat well or keep up with prenatal visits, and, in the most severe cases they may be at increased risk for suicide.

Like many drugs, antidepressants fall into a gray area during pregnancy, with insufficient evidence to definitively prove the harms or benefits. Often, doctors may reserve drugs for women with more severe depression.

Paroxetine is in a family of medicines known as selective serotonin reuptake inhibitors (SSRIs) that also includes drugs such as Prozac, Zoloft and Celexa. Some SSRIs are generally considered a safe option for pregnant women, but Paxil already carries a warning label cautioning against use during pregnancy due to the potential for fetal heart defects.

To assess the connection between Paxil and birth defects, Berard and colleagues did a fresh analysis of data from 23 studies published from 1966 to 2015. The individual studies included anywhere from 500 subjects to more than 800,000.

Because the number of defects found in some studies was small, more research is still needed to confirm the findings, the authors caution. The analysis also lacked data on the severity of maternal depression, and it's possible that women who took medications for the condition had other health problems that might contribute to an increased risk for birth defects.

"As the authors themselves point out, depression during pregnancy is itself a risk factor for smoking, alcohol and substance use, and poorer nutrition - all of which may increase the risk for congenital malformations," said Dr. Roy Perlis, a psychiatry researcher at Harvard University and Massachusetts General Hospital in Boston who wasn't involved in the study.

Two recent, large studies of SSRIs that weren't included in the current analysis also suggest a risk with Paxil but not the other drugs in this family of medicines, Perlis added by email.

"We have multiple good treatment options for depression - including medications and certain kinds of talk therapy," Perlis said. "For women who do need medication treatment, there are multiple alternatives to paroxetine."

SOURCE: http://bit.ly/1Oip8Lc British Journal of Clinical Pharmacology, online January 7, 2016.