A new study published in the Archives of Pediatric and Adolescent Medicine found little prenatal impact of antidepressant exposure on behaviors of four-year-old children.

A team of Canadian and Korean researchers studied four-year-olds who were exposed to antidepressant medications (specifically, SSRIs) during the prenatal period, and found no significant behavioral differences between the antidepressant-exposed preschoolers and the non-exposed preschoolers.

Equally important finding = What DID play a significant role in the behavior of these four-year-old children was the mother's current current statte of mental health and the level of parental stress.

This is a small study, and the child behaviors it looks at primarily include attentiveness, activity, and impulsiveness - But it yields yet another piece in the puzzle of our knowledge about 1.) Use of SSRI antidepressants during pregnancy, and 2.) The effects on children of parental mental health and parental stress.

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The question of antidepressant use is a persistent and vexing one. A tough decision for both healthcare provider and consumer alike.

Check out this article from 2001 NeuroPsychiatry Reviews:
"Which is more toxic to a fetus - Antidepressants or maternal depression?"

The article does a good job of summarizing, expanding, and reflecting upon the findings of Wisner, et al in 2000, published in the American Journal of Psychiatry as "Risk-benefit decisionmaking for treatment of depression during pregnancy."

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On the heels of last week's decision by the FDA to extend the pediatric "black box" warning labels on antidepressant medications to adolescents and young adults up to age 25 - a demographic that includes thousands of young mothers - Mental Health America (MHA) (formerly the National Mental Health Association, NMHA) has released the following statement:

As with any medication, decisions to take antidepressants must be well-informed and their use must be cautiously monitored. Mental Health America offers the following tips on how best to approach this decision. Seek help if you feel depressed or experience distress that impacts your daily life.

Depression is a very serious health problem that affects 19 million American adults each year. Left untreated, it can
lead to significant problems at home, at work and with peers—as well as to life-threatening problems such as heart disease, substance abuse and suicide. In fact, 90 percent of all suicides are attributable to an untreated or under-treated mental or substance abuse disorder, particularly depression. Fortunately, depression is highly treatable with
therapy, medication or a combination of the two.

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And we wonder why so many ob/gyns don't seem cognizant of - or competent with - mental health issues as they affect pregnant and postpartum women's medical treatment?

Just saw this coverage of ACOG's warning in today's news.

Hard to believe that the American College of Obstetricians and Gynecologists (ACOG) would be so slow to issue a statement in response to FDA warnings about the use of antidepressant Paxil during pregnancy -- It has, after all, been a full YEAR since the federal agency alerted the public to potential birth defects risks.

In its "hot off the press" statement, ACOG's Committee on Obstetric Practice "recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible." This recommendation will appear in the December issue of the journal Obstetrics & Gynecology.

Not exactly on the cutting edge of information delivery! And guess what? When you go to ACOG's massive website and do a keyword search for "Paxil," one lone entry comes up. And it's a two-year-old article related to hormone therapy.

Is it just me, or is something very wrong with this picture?

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The U.S. Food and Drug Administration (FDA) has issued a safety warning on the drug Lamictal, which is used to treat both bipolar disorder and epilepsy. Lamictal, manufactured by GlaxoSmithKline, has shown to be affiliated with an "elevated rate" of cleft palate or lip in the developing fetus, when a pregnant woman takes the medication during the first trimester of pregnancy.

Back in August, GlaxoSmithKline was in discussions with Health Canada, voluntarily informing Canadian physicians of what appears to be an "elevated rate" of birth defects, compared to the babies of women who were not taking the drug in their first trimester. That was the first public indicator that something might be awry.

Late last week, the FDA issued this warning for women: "If you take Lamictal and are pregnant or are thinking of becoming pregnant, talk with your doctor. Lamictal is used for seizures or bipolar disorder, serious conditions that need treatment even during pregnancy. Do not start or stop using Lamictal without talking to your doctor. More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal."

In a separate warning issued to physicians, made public on the FDA website, they say: "Preliminary data from the North American Antiepileptic Drug Pregnancy Registry suggest a possible association between exposure to lamotrigine monotherapy during the first trimester of pregnancy and cleft lip and/or cleft palate. The oral clefts reported were few and were not part of a syndrome that included other birth defects. Other pregnancy registries of similar size have not replicated this observation. The validity of this possible association cannot be established until further data are collected in the NAAED Pregnancy Registry, in other ongoing pregnancy registries, or through other research efforts. The clinical significance of this preliminary report is thus uncertain."

Pregnant women who have been treated with this drug during pregnancy, or for whom it remains a necessary treatment during pregnancy, may register in the NAAED Pregnancy Registry (call 1.888.233.2334). GlaxoSmithKline, the manufacturer of lamotrigine, is also administering a pregnancy registry to learn more about this possible association (call 1.800.336.2176).

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Kudos toThe Houston Press, who recently did a story spotlighting the tragic story of a a local family and the use of Paxil during pregnancy, "Baby Blues: Lisa Collins took the Paxil her doctor prescribed. There was supposed to be no problem with continuing it during her pregnancy. But it turns out, there was, giving a human face to the ongoing debate over the use of SSRI antidepressants during pregnancy.

This is the kind of reporting we need on complex issues like pharmaceutical use during pregnancy - beyond the sound byte and dense enough in content to provide readers with actual take-away information!

Lisa Collins' family's suit is the first in the nation to get a trial date for a suit against Paxil manufacturer GlaxoSmithKline - set for next summer. Problems with Paxil and birth defects started to creep into the professional and public consciousness when a 2005 study published in The Teratology Society reported women who took Paxil were more likely to have infants with birth defects such as omphalocele, in which the intestines or other abdominal organs protrude from the navel, and craniosynostosis, the early closing of one or more of the sutures of an infant's head, resulting in malformation of the skull as well as mental retardation and blindness. A subsequent study published in The New England Journal of Medicine suggested that taking Paxil after 20 weeks of pregnancy greatly increases the risk of persistent pulomonary hypertension in babies.

The Houston Press reporter writes, "These studies and several others still awaiting publication would seem to offer ample proof that SSRIs and pregnancy should not mix. But many doctors remain unconvinced," going on to quote the research-physicians who worked on these studies, who point out that much of the data we have is limited, and the findings inconclusive, on the broader issue of the safety of SSRI antidepresants during pregnancy.

Which, as I have argued many a time before, is the sad truth of where things stand. We now know that Paxil is out of bounds for pregnant women. It's no longer being prescribed to these patients. But the risk vs. benefit analysis for other SSRIs still remains an issue for informed - often anguished - decision-making between a pregnant woman with depression and the physicians treating her. (Choose your doctors very carefully, and never be afraid to make a switch when you have concerns! As for the insurance cos., don't hesitate to give 'em hell when it counts.)

Just as there may be some risks from some SSRI's during some stages of pregnancy, there are also very real and serious consequences of untreated depression that impact both baby and mother. Thousands of pregnant women with depression - including myself - have experienced health benefits from SSRI medication, finding it absolutely necessary for mental and physical health during pregnancy. But our decisions have never, ever been easy. We have worried endlessly, and we have been thankful when we gave birth to healthy, beautiful babies and were ourselves healthy enough to care for them.

Is the solution to return to tricyclic antidepressants - those developed in the 1970s and (to date, anyway) not found to cause birth defects? I don't know. None of us knows - not even our doctors, not even the FDA (whose relationships with pharmaceutical firms have greatly diminished our trust in the agency's role as a public "protector").

We need to demand more research and better research in this area! And we need to each take personal responsibility as a partner in our own care, weighing the risks and benefits of any medication very carefully, while also exploring as many non-invasive strategies for supporting emotional wellness as possible. For some of us, exercise, yoga, meditation, changes in the diet, more rest, targeted stress reduction, etc. can be a valuable therapeutic boost, should we make the decision to limit or wean off antidepressants during pregnancy.

We need to keep pushing, and pushing hard, for more transperancy and accountability from pharmaceutical makers, policymakers, and the media who covers these issues.

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A lawsuit was filed against pharmaceutical co. GlaxoSmithKline on July 28, on behalf of two-year-old Adrian Vasquez of Bedford, Texas, who was born on April 19, 2004 with birth defects.

The suit alleges that Adrian's birth defects are the result of his mother's prenatal use of Paxil, a GlaxoSmithKline antidepressant drug in the SSRI class (selective serotonin re-uptake inhibitor).

The FDA recently upped the Paxil warning from a category "C" to a category "D," warning pregnant mothers that taking Paxil more than doubles the risk of a heart defect in newborn babies. As the FDA officially puts it, "Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus."

As always on this issue, we're left pretty much where we started. Some antidepressants during pregnancy = potentially bad for baby. Untreated depression during pregnancy = definitely bad for baby (with plenty of research data to back it up). As always, defer to an individual risk-benefit analysis suited to your history and your needs, in private consultation with your healthcare provider. And if you are a woman who is not convinced that your healthcare provider is up to date on the latest research in this area, or if the provider blows off your concerns or won't sit down for a sustained conversation, get a new doctor, pronto!

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