Women who use the antidepressant bupropion during early pregnancy may have an increased risk of having a baby with a particular type of heart defect, a new study suggests.

Researchers caution that it is not clear whether the medication, marketed as 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 bupropion 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.

Some studies have already linked other antidepressants -- including some of the commonly used selective serotonin reuptake inhibitors (SSRIs) -- to higher-than-average, though small, risks of certain birth defects.

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 fluoxetine (Prozac), sertraline (Zoloft) and citalopram (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 bupropion 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.

The findings do not mean, however, that depressed women on bupropion should stop taking it if they are planning a pregnancy, according to the researchers.

"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.

"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.

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.

Bupropion is also prescribed for smoking cessation, under the brand-name Zyban. In the case of smoking cessation, Reefhuis said, it may be easier for women to find an effective alternative to the drug.

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PregnancyWeekly.com

Three out of five women who have given birth to a child with a congenital heart defect (CHD) -- the number-one birth defect and leading killer of infants and newborns -- were never tested for the defect during pregnancy. This is according to a survey just released by Little Hearts, Inc.

These findings come just as CHD Awareness Week begins (Feb. 7 - 14). The Little Hearts survey found that 60 percent of parents did not know their child had a CHD until after giving birth -- because the mothers were not tested for heart defects during pregnancy.

Of these parents, nearly three out of four (71.6 percent) wished they had known their child had a CHD during pregnancy -- mostly because they would have given birth at a hospital more equipped to handle the care of newborns with a CHD (41.6 percent).

"Congenital heart defects kill more children than childhood cancer, and yet, pregnant women are not routinely tested -- and newborns are not routinely screened -- for this defect," says Lenore Cameron, President and Executive Director, Little Hearts, Inc. "Early detection is absolutely critical to the successful treatment of congenital heart defects and, in countless cases, it saves lives."

Those families that did know their child had a CHD before giving birth (40.0 percent) reaped tremendous benefits from knowing in advance:

• Three out of five (59.5 percent) said they gave birth at a hospital more equipped to handle the care of newborns with a CHD
• One in five (19.8 percent) prepared themselves mentally and emotionally for the arrival of a seriously ill child
• Others did their homework: 14.9 percent of respondents said they arranged for a pediatric cardiologist in advance of their baby's arrival, and 5.8 percent said that knowing in advance was most beneficial because it gave them time to do research on CHDs during the pregnancy

More Survey Results

• Four out of five respondents (81.7 percent) said neither parent of the heart child had any family history of CHDs
• Giving birth to a child with a CHD was more common for women in their 30s (65.2 percent) than in any other age group
• Three out of four respondents (76.1 percent) said the mother did not take prescription drugs (which is considered a CHD risk factor) while pregnant with the heart child
• Almost all respondents (96.4 percent) have only one child with a congenital heart defect; 3.6 percent have two or more children with a CHD
Nearly three out of five respondents (58.0 percent) said their heart child has two or more CHDs; 42.0 percent said their heart child has one CHD
• The most common CHD among children of respondents was Hypoplastic Left Heart Syndrome (30.3 percent), a very serious heart defect that occurs when the left side of the heart does not develop completely

There are approximately 35 different types of CHDs. Some may be treated with surgery, medicine and/or devices, such as artificial valves and pacemakers. In the last 25 years, advances in the treatment of heart defects have enabled half a million U.S. children with serious CHDs to survive into adulthood. However, many cases of sudden cardiac death in young athletes are caused by undiagnosed CHDs and childhood-onset heart disease.

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PregnancyWeekly.com

New study findings offer reassurance to pregnant women that acetaminophen does not appear to raise the risk of birth defects.

Acetaminophen is the active ingredient in Tylenol and certain other painkillers, and is often found in over-the-counter cold and flu remedies. Taken as directed, acetaminophen is considered safe during pregnancy, making it the medication of choice for pregnant women's body aches and fevers.

However, there are still some questions about whether the drug can contribute to birth defects. Studies looking at birth defects as a broad group have either found no link to acetaminophen use or have yielded inconclusive findings.

Some research, meanwhile, has suggested that the drug may be linked to a higher risk of a birth defect called gastroschisis -- but other studies have found no such connection. Gastroschisis refers to a defect in the abdominal wall that allows the intestines to protrude; it has been linked to aspirin use during pregnancy.

In the new study, researchers analyzed data from a large U.S. study that included more than 11,600 children born with congenital defects such as spina bifida, cleft lip and various defects affecting the brain, heart, lungs, limbs and gastrointestinal system. They were compared with 4,500 children born with no major anomaly.

Overall, the study found, there was no evidence linking mothers' acetaminophen use in the first trimester to a heightened risk of any birth defect.

In fact, women who took the medication to treat a first-trimester fever had a lower risk of certain birth defects -- including gastroschisis -- than women who did not treat their fevers with acetaminophen.

Among women who had fevers in early pregnancy, babies born to those who used acetaminophen had a 65 percent to 83 percent lower risk of certain birth defects of the brain, a 56 percent lower risk of cleft lip and a 59 percent lower risk of gastroschisis.

The researchers note that hyperthermia, or excessively high body temperature, has been implicated in the risks of certain birth defects. More studies, they conclude, are needed to confirm whether treating fevers with acetaminophen does in fact prevent some birth defects.

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PregnancyWeekly.com

The FDA has issued a statement reminding patients and doctors that valproate sodium, valproic acid, and divalproex products increase the risk of birth defects in babies exposed to the chemicals during pregnancy.

The medications - used to treat epilepsy since 1978 and more recently for bipolar disorder and migraine - can cause neural tube defects, craniofacial defects, and cardiovascular malformations in unborn children during the first trimester. This is often before many women know they are pregnant, the FDA said in a statement.

Use of the products increases neural tube defects during the first 12 weeks of pregnancy from one in 1,500 to one in 20, on average, the FDA noted.

Babies born to women taking valproate for epilepsy are more than three times as likely to have birth defects as those born to women on a different therapy (10.7%, 95% CI 6.3% to 16.9% versus 2.9%, 95% CI 2.0% to 4.1%), according to data from the North American Antiepileptic Drug Pregnancy Registry.

The FDA cautioned women of childbearing potential to take valproate only if it is essential for managing a medical condition. Those taking the drug who are not planning pregnancy should use contraception, the agency said.

Women planning to become pregnant can reduce the risk of congenital neural tube defects by taking folic acid before and during the first trimester of pregnancy, the FDA noted.

The agency also noted a danger to pregnant mothers and their child if epilepsy or bipolar disorder is left untreated while the baby is developing. Likewise, it reminded doctors and patients of a major risk associated with ceasing valproate therapy suddenly.

The FDA recommended that women talk with healthcare professionals before stopping use of valproate products if they become pregnant.

It also recommended women who become pregnant while taking valproate or other antiepileptic drugs enroll in the North American Antiepileptic Drug Pregnancy Registry to help gather more information on the safety of the medications during pregnancy.

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PregnancyWeekly.com