The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

AMA Review: Antidepressants Pose Significant Risk of Serious Harm to Babies

You may have seen headlines this weekend or last week claiming that antidepressants are safe for pregnancy or that the ACOG recommends them for pregnant women. I did a little investigation over the weekend and I found that the AMA conducted a review of all the available research on antidepressants in pregnancy in 2007.

I will post a more extensive update later when I have more time. At the moment I am in a big rush so I am only posting a few points.

While carefully reading the review I noticed two things:

1) The authors did seem a little desperate to let antidepressants off the hook despite repeated findings that they could cause severe harm, making statements like “But this did not control for maternal depression” as though antidepressants would have reduced birth complications and defects otherwise.

2) Despite the fact that the joint council had voted for the AMA to promulgate clinical recommendations based on their findings, the AMA changed their mind midway through the process of researching and writing, and decided to hold off on making clinical recommendations, after the ACOG and APA asked them to wait until they could do something. It seems like the ACOG and APA read the extensive AMA report as a basis for forming their recommendations.

You can see the AMA report here:
http://www.ama-assn.org/ama/no-index/about-ama/17742.shtml.

Note that numerous people on the ACOG / APA report have conflicts of interest personally or at their university, while media articles covering this have quoted conflicted doctors making statements which contradict what the ACOG / APA report actually says. In addition, many of the “counterpoint” articles cited in the review were conducted by corrupt researchers who either have extensive conflicts of interest / involvement with pHARMa companies, or they are under Senate investigation for nondisclosure while working on federally funded research on pregnant and nursing women. The ACOG and APA themselves have extensive conflicts of interest.

Amery Schultz found some of the conflicts pertaining to the report or media coverage simply by googling “Dr. _____ Conflicts of Interest” or “Dr. _____ disclosure.”

Others have been documented extensively by Evelyn Pringle in her MOTHERS Act series.

Here is the quote from the AMA report that makes it look like the ACOG and APA may have hijacked the AMA’s plan to put forth treatment guidelines on SSRIs / SNRIs in pregnancy.

Resolution 519 (A-06), introduced by the American Academy of Child and Adolescent Psychiatry, American Academy of Pediatrics (AAP), American Psychiatric Association (APA), and the American Academy of Psychiatry and the Law, and adopted as amended, asked that our American Medical Association (AMA) work with all appropriate specialty societies to prepare a report summarizing the research on the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and to promulgate appropriate guidelines concerning the treatment of depression during pregnancy.

During preparation of this report, the Council learned that the APA and the American College of Obstetricians and Gynecologists (ACOG) were collaborating to develop guidance on the use of antidepressants in pregnancy. Therefore, as requested, this report summarizes the research on the use of SSRIs during pregnancy, but defers any action on clinical practice guidelines for the treatment of depression during pregnancy until the APA and ACOG complete their collaborative effort.

Here are some selected excerpts from my press release on Indiana Delahunty’s death.

As reported by Vera Sharav, “In April, 2004, the National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) panel issued a Report after examining all the available published evidence about infants exposed to an antidepressant in utero and / or breast fed by mothers taking an antidepressant.”

Sharav continued, “The NTP-CERHR expert panel found reason for concern:

Late pregnancy exposures were associated with increased incidence of prematurity, reduced birth weight and length at full term, and poorer neonatal condition characterized by admission to special care nursery and adaptation problems (e.g., jitteriness, tachypnea, hypoglycemia, hypothermia, poor tone, respiratory distress, weak or absent cry, or desaturation on feeding).

“The authors concluded that the observed effects are specific to SRI exposure rather than underlying maternal depression.”

This report, titled “The REPRODUCTIVE and DEVELOPMENTAL TOXICITY of FLUOXETINE”, was originally available at http://cerhr.niehs.nih.gov/news/fluoxetine/fluoxetine_final.pdf.

As if the conclusions of the report were not bad enough, various studies demonstrate that antidepressants double spontaneous abortions and stillbirths and quintuple preterm births. Babies exposed to SSRIs have a six-fold increased risk of persistent pulmonary hypertension (PPHN), a potentially fatal lung problem. Nearly a third of women who take SSRIs have a baby who dies, is premature or underweight, or who has seizures.

Regarding the required FDA warnings and label changes the AMA stated:

Labeling changes to SSRIs/SNRIs

Following the June 9, 2004, meeting of the FDA’s Pediatric Subcommittee of the Anti-infective Advisory Committee, the Committee strongly endorsed class labeling for the neonatal toxicity/withdrawal syndrome related to in utero exposure to SRIs. Accordingly, class labeling changes were adopted that caution physicians and patients about neonatal complications associated with late pregnancy exposure and note that such complications have required prolonged hospitalization, respiratory support, and tube feeding. The label lists the clinical features of the SRI-related neonatal syndrome; suggests a withdrawal or toxicity mechanism, including serotonin syndrome for these symptom clusters; and states that tapering the medication in the third trimester might be considered an option to reduce or prevent these symptoms. The label also notes that women who discontinued antidepressant medication during pregnancy are more likely to experience a relapse of major depression than those who continue antidepressant medication.

Subsequently, class labeling changes incorporated the emerging data on pulmonary hypertension by noting that infants exposed to SSRIs in late pregnancy may have an increased risk for PPHN.

Specific warnings are advanced for paroxetine regarding its association with an increased risk for congenital and cardiac malformations.

Finally, in contrast with much of the media coverage of the ACOG release claims that antidepressants are safe, the AMA report concluded:

“SRIs carry a small but significant risk for serious medical consequences.”

My comment: I am not certain how reliable their conclusion of the risk being a “small but significant” one really is, considering the apparent or probable lack of any attention to the recent MedWatch data, and the extensive conflicts of interest among some of the report’s cited researchers, some of whom are under investigation.

Given that in the past three years the rate of antidepressant use among pregnant women has skyrocketed from “over 1%” to approximately 13%, I can only imagine how many babies are dying now.

Filed under: antidepressants, Pregnancy, , , , , ,

3 Responses

  1. If you look at the growth rate of anti-depressant use in women over the years, there is also an increasing growth in the number of baby’s dying from SIDS. If only we could know which mother’s were on medication and see how many were actually killed by these drugs.

  2. [...] & Pregnancy Jump to Comments You may have read a couple of posts I recently wrote (see: here and here) after I was contacted for a possible story on TV by an ABC producer regarding the ACOG / [...]

  3. [...] when the AMA and ACOG reports were issued in August, my opinion of Oberlander changed. A report was issued in the media which [...]

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