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Paxil, a widely prescribed antidepressant has been linked to increased risk of heart malformations in infants whose mothers took the dangerous drug while pregnant. According to a June 24, 2010, Consumers Affairs news article, the manufacturer of Paxil agreed to settle nearly 200 individual cases claiming that the antidepressant caused birth defects.

Most of the cases allege that babies born to mothers taking Paxil suffered from heart defects. The leading case, brought on behalf of Lyam Kilker, contended that he was born with no fewer than three cardiac defects, including a hole between the two chambers of his heart that disrupted the aorta.

That case is so far the only one to have gone to trial. Last October, a Philadelphia jury awarded Kilker’s family $2.5 million in compensatory damages. At trial, the plaintiffs said that animal testing suggested to manufacturer GlaxoSmithKline (GSK) that the drug might cause problems, but that the company failed to follow up sufficiently with additional tests.

Even worse, a company memo introduced into evidence talked about covering up any test results that showed a potential danger. “If neg, results can bury,” read the memo by GSK executive Bonnie Rossello in 1997, before any tests were conducted.

In 2005, the FDA warned doctors about a study showing that babies born to women who took Paxil during the first trimester of pregnancy had a higher rate of major birth defects. The study, which involved 3,500 pregnant women, showed that those on Paxil were twice as likely to have a child with defects than women on other antidepressants.

In the wake of the study, the FDA put out a statement warning that “[h]ealthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.”

The terms of the settlements are to remain confidential. At least 600 cases have been filed alleging that Paxil is responsible for congenital birth defects, and an attorney for the plaintiffs said that up to 100 other cases have already settled. GSK has also paid approximately $1 billion in settlements of Paxil-related cases not involving birth defects.

For several years, Paxil and Prozac, two widely prescribed antidepressants have been associated with life threatening side effects. Paxil has been linked to increased risk for heart malformations in infants whose mothers took Paxil while pregnant and Prozac has been linked to Persistent Pulmonary Hypertension of the Newborn (PPHN).

On May 4, 2010, a new study revealed that women who use the antidepressant Wellbutrin during early pregnancy may have an increased risk of having a baby with a particular type of heart defect, according to a recent Reuters Health news report.

Researchers caution that it is not clear whether Wellbutrin is the cause. And even if it is, they say, the absolute risk of the heart defect would be small, affecting just 2 out of every 1,000 infants born to women who used Wellbutrin during the first trimester.

But the findings, published in the American Journal of Obstetrics & Gynecology, do add to questions about the risks of using antidepressants during early pregnancy. A study last year, for example, found that among nearly half a million Danish children born between 1996 and 2003, the risk of heart defects was elevated among those whose mothers had used SSRIs such as Prozac, Zoloft and Celexa during early pregnancy.

In this latest study, researchers found that among more than 12,700 U.S. infants born between 1997 and 2004, those whose mothers used Wellbutrin during early pregnancy had more than double the risk of heart defects known as left outflow tract defects, compared with infants whose mothers had not used the drug.

Left outflow defects affect the flow of blood from the heart’s left chambers to the rest of the body. In this study, the most common type of this defect was coarctation of the aorta, a narrowing in the body’s main artery that, in children, typically requires surgical repair.

“I think it’s important that women understand that they should not just stop taking their medication,” said Dr. Jennita Reefhuis, a senior epidemiologist at the U.S. Centers for Disease Control and Prevention and one of the researchers on the study.

Instead, she told Reuters Health, women should talk with their doctors, ideally when they are planning a pregnancy rather than after they conceive.

The potential risk of birth defects from using antidepressants must be weighed against the risks of a woman stopping her current depression therapy, Reefhuis said.

For the study, Reefhuis and her colleagues used data on 6,853 infants born with a major heart defect and 5,869 infants with no birth defects. Of mothers whose babies were born with a heart defect, 0.5 percent reported using bupropion at some point in the month before becoming pregnant or the first trimester.

There were 10 cases of left outflow tract heart defects among mothers who had used bupropion. The drug was not linked to any other type of heart defect.

“This study needs to be replicated before we can say anything conclusive,” Reefhuis said, noting that the findings point to an association between bupropion and left outflow defects, but cannot by itself prove cause-and-effect.

If the association is causal, she said, the absolute risk to any one woman would be small. For every 1,000 births, there are an estimated 0.8 cases of left outflow tract heart defects; based on the current findings, that rate would be 2 per 1,000 among women who use bupropion in the first trimester.

Reefhuis also pointed out that with any pregnancy, the overall risk of having a baby with some form of birth defect is 3 percent.

She recommended that women on antidepressants who are planning a pregnancy talk with their doctors about their options. There are, however, no depression medications that have been established as “safe” for pregnant women, according to Reefhuis. More research on the potential effects of all antidepressants on the developing fetus is still needed, she said.

Guidelines released last year by the American Psychiatric Association and the American College of Obstetricians and Gynecologists state that psychotherapy may be an effective alternative to antidepressants for pregnant women with mild to moderate depression.

However, the guidelines say, women with a history of more severe depression, or other major psychiatric disorders, may need to continue with their medication.

A new study claims that widely prescribed antidepressants may cause delayed lactation in new mothers, meaning they may need additional support in order to breast-feed their babies, HealthDay News reports.

Researchers determined that antidepressants called selective serotonin reuptake inhibitors (SSRIs), which include Prozac and Paxil, might be linked with delayed secretory activation, which is a delay in the initiation of full milk secretion. “The breasts are serotonin-regulated glands, meaning the breasts’ ability to secrete milk at the right time is closely related to the body’s production and regulation of the hormone serotonin,” study co-author Nelson Horseman, of the University of Cincinnati, said in a news release from the Endocrine Society.

Horseman and colleagues studied the effects of SSRI drugs on lactation in laboratory research using human and animal cell lines, as well as mice. They also evaluated the effect of SSRIs in 431 new mothers and found that median onset of lactation was 85.8 hours after birth among those who used SSRIs, compared with 69.1 hours for those who weren’t taking the drugs. Delayed secretory activation is commonly defined as lactation that begins more than 72 hours after birth.

The study has been accepted for publication in an upcoming issue of the Journal of Clinical Endocrinology & Metabolism.

Over the past several years the FDA has warned that Paxil used during pregnancy can cause birth defects in newborns and babies whose mothers took Prozac while pregnant may be born with persistent pulmonary hypertension.