Paxil, Neonatal Withdrawal Syndrome and Birth Defects

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.

Neonates exposed to Paxil and other SSRIs or SNRIs, late in the third trimester have developed complications requiring

  • prolonged hospitalization
  • respiratory support
  • tube feeding
  • Such complications can arise immediately upon delivery. Reported clinical findings have included

  • respiratory distress
  • cyanosis
  • apnea
  • seizures
  • temperature instability
  • feeding difficulty
  • vomiting
  • hypoglycemia
  • hypotonia
  • hypertonia
  • hyperreflexia
  • tremor
  • jitteriness
  • irritability
  • 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

  • not being able to sleep or feed properly
  • trouble with breathing
  • a blue-ish skin or being too hot or cold
  • being sick
  • crying a lot
  • stiff or floppy muscles
  • lethargy
  • tremors
  • 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.

    GSK's "Do More, Feel Better, Live Longer" video
    (Windows Media Player or RealOne Player required to view)

    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

  • irritability
  • hyperactivity
  • abnormal sleep pattern
  • high-pitched cry
  • tremor
  • vomiting
  • diarrhea
  • weight loss
  • 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.


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

    *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.

  • Paxil Sales Memo
  • Business Plan Guide
  • Money Bag Memo
  • "Where's My Paxil!"
  • 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


    Where does the Food and Drug Adminstration (US) stand on the isssue? On June 9th, 2004 FDA’s Pediatric Subcommittee of its Anti-Infective Drugs Advisory Committee recommended antidepressant pregnancy exposure risks should be described in patient labeling. The proposed precaution states: “Neonates exposed to SSRI/SNRI late in 3rd trimester have developed AE requiring prolonged hospitalization, respiratory support, tube feeding. AE may arise immediately upon delivery.” The side effects of agitation, irritability, trouble feeding etc. could be the sign of a withdrawal syndrome, FDA said.

    "Could be." Which brings to mind that old saying: "If it looks like a duck, walks like a duck and quacks like a duck — it's probably a duck."

    Paxil and Birth Defects

    In September, 2005 the public was blindsided by stunning news coming out of Australia: The Therapeutic Goods Administration reclassified paroxetine (Paxil/Seroxat/Aropax ) from a pregnancy "category C" drug to a "category D" drug, recommending it be avoided in pregnancy.

    Details from a preliminary analysis of GlaxoSmithKline data showed a higher incidence of congenital malformations, particularly ventricular septal defects, in babies born to women taking the drug.

    Babies of women taking paroxetine in the first trimester of pregnancy were 2.2 times more likely to be born with a congenital malformation and 2.08 times more likely to have a cardiovascular malformation than those born to women taking other antidepressants, the data showed.

    A second population-based Danish study found a 60% increase in cardiac abnormalities among babies of mothers taking SSRIs.

    Once again the public must ask: What did GlaxoSmithKline know, when did they know it, and did they hide the risks?

    To compare the Food and Drug Administration's most current (2003) teratogenicity (the property or capability of producing fetal malformation) ratings of common antidepressants click here. (PDF document)

    GlaxoSmithKline released a four page (PDF) document to its main web site discussing a link between birth defects and women who take Paxil during pregnancy. As usual, the company seeks to minimize the apparent linkage.

    Paxil Birth Defects: Legal Help

    If you, or someone's child you know, suffered Neonatal Withdrawal Syndrome at birth — or birth defects — after taking Paxil 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.