Moms' antidepressants hit third of newborns: study

[scotty]

Ah, the release of this study makes it perfectly clear why we had the flurry of "pregnant women need to continue to take their antidepressants" coverage. Never doubt that Pharma has ability to make a preemptive strike to try and water down bad news.



http://today.reuters.com/news/newsAr...ntidepressants

CHICAGO (Reuters) - Nearly one in three infants born to women taking
anti-depressant drugs exhibit signs of withdrawal and expectant
mothers may want to limit the drugs they take, researchers said on
Monday.

Symptoms such as high-pitched crying, tremors, gastrointestinal
problems and disturbed sleep may show up in the first 48 hours after
birth and were more pronounced in infants whose mothers had been
taking higher doses.

A closer look at the 37 infants exposed in the womb to paroxetine
hydrochloride, sold as Paxil by GlaxoSmithKline, showed the risk of
symptoms disappeared if the mother's dosage was less than 20
milligrams daily while the risk was highest among those exposed to
27 milligrams or more.

Thirty percent of the 60 newborns exposed to one of the popular
class of drugs known as selective serotonin reuptake inhibitors
(SSRIs) in the womb were found to have withdrawal symptoms and the
symptoms were classified as severe in 13 percent, said the study by
Dr. Rachel Levinson-Castiel of the Children's Medical Center of
Israel, in Petah Tiqwa.

Symptoms usually did not peak until after the first day of life but
the long-term effects are not known, the study said.

Two of the exposed infants suffered seizures but they did not
persist.

Previous studies into the effects of SSRIs on newborns have
identified other symptoms such as rapid breathing, bluish skin color
from lack of oxygen, feeding difficulties, low blood sugar and
jitteriness.

Yet a study published last week by researchers at Massachusetts
General Hospital in Boston said women who need an antidepressant
cannot depend on hormonal changes in pregnancy to relieve their
symptoms so may choose to continue taking the drug.

"Because maternal depression during pregnancy also entails a risk to
the newborn, the risk-benefit ratio of continuing SSRI treatment
should be assessed," Levinson-Castiel wrote in the journal Archives
of Pediatrics and Adolescent Medicine.

Unfortunately, "the long-term effects of in utero exposure to SSRIs
have not been demonstrated clearly," not even for those whose
symptoms were severe early on, she wrote.

Both studies recommended pregnant women simplify their drug regimen
to a single drug at the lowest effective dose.



© Reuters 2006. All Rights Reserved.

[scotty]

Here's the actually study report

Neonatal Abstinence Syndrome After In Utero Exposure to Selective
Serotonin Reuptake Inhibitors in Term Infants
Rachel Levinson-Castiel, MD; Paul Merlob, MD; Nehama Linder, MD; Lea
Sirota, MD; Gil Klinger, MD


http://archpedi.ama-assn.org/cgi/con...hort/160/2/173



Arch Pediatr Adolesc Med. 2006;160:173-176.

Objective To compare the prevalence and clinical characteristics of
neonatal abstinence syndrome in neonates exposed and not exposed to
selective serotonin reuptake inhibitors (SSRIs) in utero.

Design Cohort study.

Setting Tertiary care center.

Patients One hundred twenty term infants, of whom 60 had prolonged
in utero exposure to SSRIs, including paroxetine hydrochloride,
fluoxetine, citalopram hydrobromide, sertraline hydrochloride, and
venlafaxine hydrochloride.

Main Outcome Measures Neonatal abstinence syndrome was assessed with
the Finnegan score as follows: score of 8 or above, severe; score of
4 to 7, mild; and score of 0 to 3, normal. All infants were followed
up with a standardized protocol that included repeated Finnegan
score assessments and cardiorespiratory monitoring until
normalization of the Finnegan score.

Results Of the 60 neonates exposed to SSRIs in utero, 8 showed
severe and 10 showed mild symptoms of a neonatal abstinence
syndrome. All nonexposed neonates had a normal Finnegan score. In
neonates who developed severe symptoms, the maximum mean daily
Finnegan scores were recorded within 2 days after birth, although
maximum individual scores were recorded as long as 4 days after
birth.

Conclusions Neonatal abstinence syndrome occurs in 30% of neonates
exposed to SSRIs in utero. These neonates should be monitored for at
least 48 hours after birth. The long-term effects of prolonged
exposure to SSRIs, particularly in neonates who develop severe
symptoms, have yet to be determined.


Author Affiliations: Neonatal Intensive Care Unit, Schneider
Children's Medical Center of Israel, Petah Tiqwa (Drs Levinson-
Castiel, Merlob, Linder, Sirota, and Klinger); Department of
Neonatology, Rabin Medical Center, Petah Tiqwa (Drs Merlob, Linder,
Sirota, and Klinger); and Sackler School of Medicine, Tel Aviv
University, (Drs Merlob, Linder, Sirota, and Klinger), Tel Aviv,
Israel.

[genevieve]

thank you for posting this.
well, at first they told people that SSRIs were dangerous for the foetus, after they said that often the benefit is greater than the risk and now we are back to the first idea : 13% with severe reactions really makes you wonder...

[scotty]

I kept wondering why the big news splash on the "pregnant women relapse without ssri's during pregnancy".... now we know what was coming. Pharma trying a preemptive strike against this study. Scum!!!!

[elisa]

I was just about to post the very same article.

30% of newborns with withdrawl symptoms that can be clinically observed. What about the symptoms that babies cannot talk about as we adults can????

This research really proves that withdrawl really exists and can no longer be denied as babies cannot pretend. It also proves the addictive nature of these drugs.

Yes, Laurie, too much of a co-incidence that these reports about pregnant women were released prior to this more detailed "new" research on the newborns.

[elisa]

Here's another link on the same subject.

http://www.medpagetoday.com/OBGYN/Pregnancy/tb/2627

[rdjanis]

Very sad, I feel sorry for the moms told it was okay and find themselves pregnant and on paxil, it must be extremely scary for them.

[elisa]

neonatal abstinence syndrome.

The word "abstinence" sounds a lot like addiction-related to me.

New words for yet the same symptoms experienced by adults.

[scotty]

Another "syndrome" make up by a marketing executive to avoid using the word withdrawal!

[elisa]

Originally Posted by scotty

Another "syndrome" make up by a marketing executive to avoid using the word withdrawal!

In my view they're afraid to use the same term for newborns and children as for the adults (discontinuation).

It's all the same but more jargon and confusion created, as if babies are not human beings going through the same withdrawl. Are they different because they can't reason yet?

I don't believe this playing with words would be acceptable in other areas of medicine.

[Healing]

Good catch, Laurie, about the pre-emptive strike. Fu*ckers.

[MrsB]

Originally Posted by rdjanis

Very sad, I feel sorry for the moms told it was okay and find themselves pregnant and on paxil, it must be extremely scary for them.

Yes, it's very, very scary.... not only am I terrified of what paxil may have done to my unborn child, I'm afraid of the long term damage it has done to me after taking it so long.
I'm 12 weeks pregnant, and in the midst of a taper- I've got about 5 more weeks before I'm done with this S****! I so want to quit cold turkey but I'm even more afraid of the worse effects of that.
What a mess us pregnant on paxil women are in- I feel like I'm talking about someone who's been on crack or heroin, not a prescription drug.
I think I'm in the angry phase of withdrawal, so you'll have to excuse me.

[paxilinfidel]

And of course, at the corner of this article was a colorful ad for yet another lovely pharmaceutical pellet.........

[scotty]

Originally Posted by MrsB

Yes, it's very, very scary.... not only am I terrified of what paxil may have done to my unborn child, I'm afraid of the long term damage it has done to me after taking it so long.
I'm 12 weeks pregnant, and in the midst of a taper- I've got about 5 more weeks before I'm done with this S****! I so want to quit cold turkey but I'm even more afraid of the worse effects of that.
What a mess us pregnant on paxil women are in- I feel like I'm talking about someone who's been on crack or heroin, not a prescription drug.
I think I'm in the angry phase of withdrawal, so you'll have to excuse me.

And you have every right to be angry. Take it slow..

[Tomas2]

Originally Posted by scotty

Another "syndrome" make up by a marketing executive to avoid using the word withdrawal!

Actually, neonatal abstinence syndrome seemingly is a term originally used to describe symptoms of newborns withdrawing from opiates.

http://neonatal.peds.washington.edu/NICU-WEB/nas.stm