TO DRUGS CAUSING SPONSTANEOUS ABORTION AND BIRTH DEFECTS

STUDIES AND DRUG REGULATORY AGENCY WARNINGS AGAINST PSYCHIATRIC DRUG USE DURING PREGNANCY

EXECUTIVE SUMMARY

Any legislation that provides for further funding of research into “post partum depression” opens the door to creating an even greater risk to pregnant women. Such research ultimately recommends biological (drug) treatments, which never cure, but potentially damage and place newborns at risk of serious physical problems, withdrawal and even death.  Dozens of studies already show that these drugs are hazardous to pregnant women and infants.

"These babies are bathed in serotonin [from Prozac-like antidepressants] during a key period of their development and we really don't know what it's doing to them or what the long-term effects might be. It could be that they go ‘cold turkey' when they are born or the serotonin could be having an effect on their brains, or it could be a bit of both." 

Philip Zeskind, a professor of pediatrics,

The American Journal of Pediatrics 2004

BIRTH DEFECTS AND OTHER ADVERSE EFFECTS SUFFERED BY INFANTS WHOSE MOTHERS WERE PRESCRIBED ANTIDEPRESSANTS DURING PREGNANCY

Abnormal crying

Agitation

Bluish skin color from lack of oxygen

Breathing problems

Congenital anomaly (abnormality)

Convulsions

Feeding difficulties

Heart defects

Low birth rate

Jitteriness

Lethargy

Miscarriage

Neurological problems (symptoms include irritability, constant crying, convulsions) 

Omphalocele (abnormality in which the infant's intestine or other abdominal organs protrude from the navel)

Premature birth

Rapid breathing

Respiratory difficulties

Restlessness

Rigidity

Seizures 

Small intestine defects

Spontaneous abortions

Suction problems

Tremors

Withdrawal effects, including convulsions, agitation (symptoms could begin on the first day after birth and persist for 10 days even though levels of the antidepressant were undetectable on day 6)

These adverse reactions were reported in: Archives of Pediatrics and Adolescent Medicine, New England Journal of Medicine, World Health Organization, Epidemiology, The Archives of General Psychiatry, Harvard, The American Journal of Pediatrics, Science, American Journal of Obstetrics and Gynecology, Archives of Pediatrics and Adolescent Medicine, Journal of The American Medical Association, the FDA, Australian Therapeutics Goods Association.

§         According to one of the world's leading experts on SSRI (Prozac-like) antidepressants, Dr David Healy, a professor at the University of Wales College of Medicine, "There is quite a movement at the moment to say all pregnant women are depressed."  However, "There is no good reason to prescribe antidepressants, because only 1 out of 10 people are likely to respond to the drugs rather than to attention and support." "So in essence," he notes, "nine out of 10 pregnant women will be subject to the risks of the SSRIs….”

§         Experts critical of antidepressant use during pregnancy all agree that in the absence of any proven effectiveness of treatment with SSRIs, potential harm to the fetus cannot be justified.

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 WHY H.R. 20/S. 1375, THE “MOTHER’S ACT” IS OPEN TO ABUSE

The “Mother’s Act” (H.R. 20/S.1375) has a reported purpose to ensure that new mothers and their families are educated about postpartum depression, screened for symptoms, and provided with essential services, and to increase research at the National Institutes of Health on postpartum depression.  There are numerous problems with this bill:

• Despite the fact that the National Institute of Mental Health (NIMH) has already spent nearly $19 million during the last 10 years on postpartum depression, with no effective treatments found, the Mother’s Act calls for an unspecified amount of money over the next two years for even more research.  
• The bill does not acknowledge that there is diverse medical opinion about “postpartum depression” and whether it exists as a mental disability or as a physical condition that can be treated by normal medical or alternative means, already available.   
• Of great concern, the National Center for Complementary and Alternative Medicine lists no research grants for postpartum depression on its website for the last 3 years, and the bill provides no indication that alternatives that would be safer to both mother and child are available.   
• The only treatment for put forth in the bill for women either during pregnancy or after childbirth is biological agents (antidepressants or other psychotropic drugs), when naturopaths, chiropractors and others in the alternative health field confirm there are natural ways of treating so-called post partum depression.   
• The bill fails to address the fact that studies show that antidepressants prescribed to pregnant women can cause miscarriage, premature birth, and in babies born to pregnant women taking these drugs, congenital heart birth defects, life-threatening lung disease, neurological symptoms, and withdrawal symptoms.   
• This treatment modality forwarded by the bill could lead to thousands of lawsuits, as hundreds have already been filed concerning the effects of antidepressant use during pregnancy.  Children have been born with club foot, cleft pallet, and some have required several surgeries to correct the condition alleged to have been caused by psychiatric drug use during pregnancy.    
• Mental health screening, whether for postpartum depression or otherwise, is not the same as medical testing that show a tangible result. Rather it relies upon subjective questionnaires that are then evaluated based solely on opinion.    
• This bill makes no provision to protect women from this, to protect the fetus and infants from harmful psychotropic drugs most commonly prescribed for “post partum depression” and opens the door to massive increases in healthcare costs arising from treatment of iatrogenic-caused conditions through drug prescriptions.

SAMPLE STUDIES SHOWING PSYCHOTROPIC DRUG USE DURING PREGNANCY IS DANGEROUS, PLACING THE FETUS, MOTHER AND INFANTS AT RISK

May 1993:  A study published in the Journal of The American Medical Association reported that of 117 pregnancies where the mother took Prozac during the first trimester, the risk of miscarriage was 14.8% compared to 7.8% in mothers not exposed to Prozac or other antidepressants.[1]

August 1993:  Between 1988 and August 1993, the FDA Adverse Drug Reaction reports for listed incidents of 17 babies being born with a congenital anomaly to mothers who had taken Prozac prior to or during pregnancy.[2]

November 1993:  Eli Lilly, manufacturer of Prozac, admitted that the risk of spontaneous abortion in women taking Prozac was as high as 15.9% and 3.4% perinatal (around the birth) malformations.[3]

1996: The New England Journal of Medicine reported a study that showed higher rates of premature delivery, low birth weight, admissions to intensive care units, including respiratory and feeding difficulties, and jitteriness, in children born to women who took Prozac during pregnancy. [4]

March 2003: A Harvard study showed that infants exposed in the womb to valproate (Depakote, Depakene or Epivil) prescribed for mood disorders, had twice as many birth defects as previously thought—8.8% had serious abnormalities compared to previously reported rate of 4%.[5] 

July 2003:  A Finnish study published in The Archives of General Psychiatry found that infants whose mothers took antidepressants during pregnancy could suffer neurological problems during their first week of life.  The symptoms included tremors, restlessness and rigidity.  Previous studies had shown that pregnant women taking SSRIs during the third trimester of pregnancy could experience neurological symptoms such as irritability, constant crying, convulsions and eating and sleeping disorders.[6]

August 2003: The Australian Therapeutic Goods Administration reported that the use of SSRIs during or after pregnancy could result in newborn babies experiencing withdrawal effects and could also experience a toxic effect from ingestion of an SSRI in breast-milk.  withdrawal effects the baby experienced included agitation, jitteriness, poor feeding, sleepiness/lethargy, gastrointestinal symptoms and hypotania (deficient tone or tension).[7]

2004: The FDA revised SSRI labels to warn that some infants had developed problems requiring prolonged hospitalization, respiratory support, and tube feeding. [8]

February 2004:  The American Journal of Pediatrics found direct evidence of a link between fetal exposure to SSRIs and disrupted neurological development. "Researchers linked abnormal sleeping patterns, heart rhythms and levels of alertness” to

SSRIs.[9]

June 2004: A study published in Prescrire International found that newborns exposed to SSRIs toward the end of pregnancy showed signs of agitation, altered muscle tone, and breathing and suction problems, with an estimated 20% to 30% of the infants in the study affected. [10]

June 2004: The FDA also recorded 19 adverse events in pregnant women who took Effexor, an antidepressant closely related to SSRIs, including seizures, jitteriness, and jaundice. [11]

July 2004: The adverse event reports prompted the FDA to change the labeling for all SSRIs, warning that newborns exposed to SSRIs have developed problems requiring prolonged hospitalizations, respiratory support, and tube feeding. [12]

October 2004: Researchers from Columbia University published a study in the journal, Science, suggesting that exposure to Prozac in the womb and in early childhood may permanently alter the brain's circuitry and disrupt neural development, leading to serious emotional disorders later in life. [13]

2005:  Researchers in France published a paper suggesting that serotonin exerts an impact on developmental processes of the embryo much earlier than previously believed. According to psychiatrist, Dr Grace Jackson, author of Rethinking Psychiatric Drugs: A Guide for Informed Consent, prescribing SSRIs as a preventative measure during pregnancy is a terrible idea. The major reason why preventive use is so dangerous, she says, is the research suggesting that the SSRIs exert a direct effect upon the early embryo.[14]

February 2005:  Researchers from the University of La Laguna in Spain reported the use of antidepressants was associated with newborn withdrawal syndrome, in the British medical journal, Lancet—symptoms include convulsions, irritability, abnormal crying and tremor. [15]

September 2005: The Journal of Psychopharmacology published a study in which researchers discussed whether the symptoms found with infants at birth represented Paxil (paroxetine) toxicity or a withdrawal syndrome. The infant's symptoms began on the first day after birth and persisted for 10 days even though levels of paroxetine were undetectable on day 6. [16]

September 2005:  GlaxoSmithKline (GSK) advised health care professionals of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRIs were more likely to have an infant with omphalocele (abnormality in which the infant's intestine or other abdominal organs protrude from the navel). The study above also found an association of exposure to SSRIs and giving birth to an infant with craniosynostosis (a congenital defect-present at birth. The connections between sutures-skull bones prematurely close during the first year of life, which causes an abnormally shaped skull.) [17]

September 2005:  Studies conducted by Danish and U.S. researchers determined that the use of SSRIs in the first three months of pregnancy was linked to a 40% increased risk of birth defects such as cleft palate and cardiac defects appeared to be 60% more likely when women used SSRIs.[18]

September 2005:  The Australian Therapeutic Goods Administration warned health professionals warning that SSRI use—especially Paxil—in early pregnancy could cause congenital heart abnormalities in newborns.[19]

September 2005:  The FDA and GSK issued a warning that pregnant women taking Paxil or other antidepressants during their first trimester of pregnancy experienced an increased risk of major congenital (birth defect) and cardiovascular malformations at birth; also premature births in pregnant women exposed to SSRIs.[20]

February 2006: An analysis of World Health Organization medical records found that infants whose mothers took antidepressants while pregnant may suffer withdrawal effects.  A study conducted by researchers at the University of British Columbia and published in the British Lancet. [21] Researchers determined that about one out of three newborns exposed to SSRIs in the womb showed signs of neonatal (newborn) drug withdrawal. About 30% exhibited signs of withdrawal in the hours after birth. None of the infants who were not exposed to SSRIs had symptoms. [22]

February 2006: The Archives of Pediatrics and Adolescent Medicine reported that nearly one-third of newborn infants whose mothers took SSRI antidepressants during pregnancy experienced withdrawal symptoms.  Previous studies had identified other symptoms such as rapid breathing, bluish skin color from lack of oxygen, feeding difficulties, low blood sugar and jitteriness.[23] 

February 9, 2006: The New England Journal of Medicine found that mothers who took SSRIs in the second half of their pregnancies were 6 times more likely to give birth to infants with a lung disorder called persistent pulmonary hypertension (PPHN). The condition occurs when a newborn's circulation system does not adapt to breathing outside the womb and causes high pressure in the blood vessels of the lungs making them unable to get enough oxygen into their bloodstream and can be fatal. Between 10% and 20% of infants with PPHN will end up dying even if they receive treatment.[24]

February 2006: In a related study involving 73 infants who were exposed to an SSRI right up until delivery, and 101 infants who were only exposed during the first trimester of pregnancy, researchers found that babies exposed throughout the entire pregnancy had significantly increased complications like hypotonia [having less than normal muscular tone or tension], respiratory problems and jitteriness compared to the other infants. [25]

March 2006: Health Canada issued a warning that SSRIs and other newer antidepressants when taken by pregnant women placed newborns at risk of developing a rare lung and heart condition.[26]

April 2006:  American Journal of Obstetrics and Gynecology reported that taking SSRIs doubled the mother's risk of delivering a stillborn infant and increased the risk of premature delivery, underweight babies, and seizures. [27]

April 7, 2006: A Canadian study from the University of Ottawa , found those who used SSRIs were more likely to have premature and low birth weight babies.  Almost 20% of women who used SSRIs gave birth prematurely, compared to 12% of mothers who did not use the drugs. Infants born to women using SSRIs were also found to be more likely to have seizures. [28]

July 2006: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took SSRIs during pregnancy.[29]

November 2006:  The journal Epidemiology published by researchers from Aarhus University in Denmark who found that pregnant women who take the newer type of antidepressants are more likely to have babies with birth defects than mothers who don’t take these drugs.[30]

December 29:  A new Canadian study published in Birth Defects Research Part B: Developmental and Reproductive Toxicology, examined in greater detail the association between first trimester exposure to paroxetine (Paxil and Paxil CR) and the occurrence of major congenital malformation, especially major cardiac malformations. Paroxetine was significantly associated with a “two-fold increase in the risk of major congenital anomalies, and more specifically with a three-fold increase in the risk of major cardiac anomalies.”[31]

May 8, 2007: The German Drug Regulatory Agency (BfArM) warned of increased risk of cardiac malformation in newborns when the mother took Paxil during pregnancy.

May 2007:  A study published in the Journal of The American Medical Association reported that of 117 pregnancies where the mother took Prozac during the first trimester, the risk of miscarriage was 14.8% compared to 7.8% in mothers not exposed to fluoxetine or tricyclic antidepressants.[32]