Paxil and Neonatal Withdrawal Syndrome

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Sun, 18 Sep 2005 20:44:04 -0400

[sSRI-Research] Paxil and Neonatal Withdrawal Syndrome

 

 

 

Paxil and Neonatal Withdrawal Syndrome

http://paxilprotest.com/page21.html

 

The side effects [of Paxil " discontinuance " ] are things like

dizziness, nausea, headache, um, and are clearly labeled in the

information made available to doctors and patients.

 

- Dr. Alastair Benbow

GlaxoSmithKline's European Medical Director

Source: GSK's web site

2004

Neonates exposed to Paxil and other SSRIs or SNRIs, late in the third

trimester have developed complications requiring

 

 

a.. prolonged hospitalization

a.. respiratory support

a.. tube feeding

 

Such complications can arise immediately upon delivery. Reported

clinical findings have included

 

 

a.. respiratory distress

a.. cyanosis

a.. apnea

a.. seizures

a.. temperature instability

a.. feeding difficulty

a.. vomiting

a.. hypoglycemia

a.. hypotonia

a.. hypertonia

a.. hyperreflexia

a.. tremor

a.. jitteriness

a.. irritability

a.. constant crying

 

These features are consistent with either a direct toxic effect of

SSRIs and SNRIs or, possibly, a drug discontinuation syndrome.

 

-from the June, 2005 Paxil prescribing information

 

 

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The above constellation of symptoms, accurately described, is known as

" neonatal withdrawal syndrome. " Yet GSK's drug labeling " wordsmiths "

employ the sleight-of-hand phrase " drug discontinuation syndrome. "

Which brings to mind former President Ronald Reagan's famous quip:

" There you go again. "

 

The term " discontinuation " is not even a legitimate medical term - it

is not listed in any recognized medical dictionary. GlaxoSmithKline

continues to hawk this phrase whenever the company thinks it can get

away with it. After all, GlaxoSmithKline knows full well the

minimizing impact watered down language can have on public perception.

 

Indeed, even mentioning the word " withdrawal " in GlaxoSmithKline's

marketing lexicon is regarded as - if not a cardinal sin - then

certainly a corporate one.

 

 

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If you are taking Seroxat in the last 3 months of pregnancy, let your

midwife know as your baby might have some symptoms when it is born.

These symptoms usually begin during the first 24 hours after the baby

is born. They include

 

 

a.. not being able to sleep or feed properly

a.. trouble with breathing

a.. a blue-ish skin or being too hot or cold

a.. being sick

a.. crying a lot

a.. stiff or floppy muscles

a.. lethargy

a.. tremors

a.. jitters or fits

 

If your baby has any of these symptoms when it is born and you are

concerned, contact your doctor or midwife who will be able to advise you.

 

-from the 2004 Seroxat Patient Information Leaflet

 

 

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In the above Seroxat labeling scheme GlaxoSmithKline says nothing

about a " drug discontinuation syndrome; " however, it is obvious on the

face of it what is happening in such circumstances. The neonate

exhibiting these presenting symptoms is, clearly, suffering neonatal

withdrawal syndrome; it has been detached from its " industrial-sized

IV tube " (a.k.a. the umbilical cord) and with that its critical drug

supply. This results in the Paxil dependent newborn being launched

fresh into the world to face the worst of all possible scenarios: a

" cold turkey " Paxil withdrawal. One has a hard time imagining a

greater horror.

 

That GlaxoSmithKline to this day negligently fails to warn the public

about the true nature of what is happening in these circumstances is

outrageous and unconscionable. And it must stop now.

 

 

*******************************

 

 

PubMed Articles on Neonatal Withdrawal Syndrome

A partial review of the available medical literature

 

1993

*Neonatal Withdrawal Syndrome: Associated Drugs and Pharmacologic

Management

Use of addicting drugs among women during pregnancy exposes newborns

to potentially serious disorders. A group of symptoms referred to as

neonatal withdrawal syndrome (NWS) may occur in infants born to

mothers addicted to certain drugs because, at birth, the infants

suddenly are cut off from the drug supply. Classes of drugs that cause

NWS are those that produce addiction in adults, including the opioids

(heroin, methadone, morphine), barbiturates, alcohol, and

benzodiazepines. Many of the manifestations of NWS occur regardless of

the class of drug, including

 

 

a.. irritability

a.. hyperactivity

a.. abnormal sleep pattern

a.. high-pitched cry

a.. tremor

a.. vomiting

a.. diarrhea

a.. weight loss

a.. failure to gain weight

 

The fact that these symptoms are nonspecific makes it difficult to

identify NWS unless it is specifically looked for. The onset,

duration, and severity of the disorder differ based on such factors as

the addictive drug used, time and amount of mother's last dose, and

rate of elimination of the drug from the newborn. Pharmacologic

intervention may be required to control severe symptoms and signs. The

most common drugs used to modify withdrawal are phenobarbital,

paregoric, chlorpromazine, and diazepam. Treatment is complicated by

conflicting information on the effectiveness of various agents.

 

 

 

 

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*Note the overlapping presenting symptoms for neonatal withdrawal

syndrome in infants suddenly cut off from a supply of Paxil/Seroxat,

and those of infants removed from heroin, methadone, morphine,

barbiturates, alcohol, and benzodiazepines. Though not identical, they

share much in common.

 

GlaxoSmithKline might leap on the fact that Paxil (nor other SSRIs)

are included in this study. The reason why they would not have been

included is simple: the study was performed in 1993. SSRIs had barely

made it into the marketplace and little, if any, data would have been

available to the authors.

 

 

Additional PubMed Articles:

Neonatal Withdrawal Syndrome

 

2001

Neonatal Withdrawal Syndrome After In Utero Exposure to Selective

Serotonin Reuptake Inhibitors.

 

2003

Neonatal Hair Analysis Contribution to Establishing a Gestational Drug

Exposure Profile and Predicting a Withdrawal Syndrome.2003

Paroxetine Withdrawal Syndrome as Differential Diagnosis of Acute

Neonatal Encephalopathy?

 

2005

SSRIs in Pregnant Women and Neonatal Withdrawal Syndrome

 

 

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" Smoking Guns " :

GlaxoSmithKline Confidential Documents

 

Beyond our review of GlaxoSmithKline substandard drug labeling there

is another issue worth examining: Confidential GSK documents.

 

The following confidential GlaxoSmithKline documents were obtained by

attorneys acting on behalf of Paxil withdrawal victims. The documents

were released into the public domain in 2004.

 

 

a.. Paxil Sales Memo

a.. Business Plan Guide

a.. Money Bag Memo

a.. " Where's My Paxil! "

a.. PR Firm Memo

 

You can also download these explosive documents from the ABC news web

site link entitled Drug Maker Withheld Paxil Study (where they first

appeared). The site is sometimes slow in loading, so please be

patient. If the article doesn't pop up after a minute or so simply try

again at a later time. (It's definitely worth the wait.)

 

Two Excerpts From " The Business Plan Guide "

 

(Paxil) " Allows for rapid washout in the case of . pregnancy. "

 

GSK attacks competitor Eli Lilly's product (Prozac), saying " The long

half-life of Prozac reduces physician control and can . Increase

exposure time to the fetus during pregnancy. "

 

Two Excerpts From The " PR Firm Memo "

 

If a patient becomes pregnant one might wish to discontinue therapy as

quickly as possible..

 

A drug with a short half life (i.e. Paxil), if discontinued

immediately after conception, could wash out before the

fetal-placental circulation is established. "

 

 

" We take the safety of our medicines extremely seriously.... "

 

 

-Dr. Alastair Benbow

GSK's European Medical Director

 

If you, or someone's child you know, suffered Neonatal Withdrawal

Syndrome at birth, please report it immediately to the United States

Food and Drug Administration. This is one way consumer leverage can be

applied to GlaxoSmithKline; eventually this official documentation

will compel the company to fully disclose the " adverse side effects "

of Paxil. You can report your side effects at: MedWatch.