Safety of Newborn Babies Threatened by SSRIs Rx during pregnancy

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[sSRI-Research] Safety of Newborn Babies Threatened by SSRIs

Rx during pregnancy

 

 

 

Safety of Newborn Babies Threatened by SSRIs Rx during pregnancy

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

The Boston Globe reports (below) that " During a hastily called press

conference yesterday, " the FDA announced that it is considering

ADDITIONAL warnings on the labels of SSRI drugs-Prozac, Paxil, Zoloft,

et al. This appears to be an effort to put out a firestorm in the

wake of the latest in a series of published reports about the

hazardous effects antidepressants have on newborn infants whose

mothers ingested them during pregnancy.

A report in The New England Journal of Medicine found that the use of

SSRIs in pregnancy poses a serious risk of pulmonary hypertension in

newborns.

 

The condition that " is associated with substantial infant mortality

and morbidity. " " Despite treatment, 10 to 20 percent of affected

infants will not survive. "

 

The demonstrable hazards of these widely prescribed drugs refute a

decade of physicians' assurances about the safety of " selective

serotonin reuptake inhibitors. " These antidepressants are neither

selective nor safe as they affect neurological, metabolic, hormonal,

and respiratory body systems. The scientific evidence is pilling up

against the use of these drugs-especially when prescribed for children

and pregnant women.

 

SSRIs pose potentially lethal hazards for unborn, developing infants

in the womb--and 30% suffer withdrawal symptoms.

 

It is becoming more and more evident that doctors--many unwittingly,

others knowingly-- are prescribing drugs that cause MORE newborns

GREATER harm than infants who suffered withdrawal symptoms due to

their mothers' crack cocaine habit.

 

Yet, the NEJM study author, Dr. Christine Chambers considers a 1 in

100 risk of fatal pulmonary hypertension-a " low " risk for infants:

 

" It's very important to get across that we don't know for certain that

the drugs actually caused persistent pulmonary hypertension, and that

if they did, the risk is still low, about one in a hundred, " said the

new study's lead author,

 

 

This is but a demonstration of the muddled thinking that afflicts

psychiatry's academics-most of whom are under the spell of drug

industry " beneficence. "

 

For example, it is disclosed that two of the authors of a JAMA report

earlier this month, which did not look at risks for infants, but

rather at relapse rates-without considering drug withdrawal symptoms

that are often misdiagnosed as relapse. That study concluded that

fewer women relapse on drugs than if they stopped taking them.

 

However, the study's conclusion is suspect inasmuch as industry's

influence is not absent: " The National Institute of Mental Health

funded this study. Two of the authors have disclosed various financial

relationships with GlaxoSmithKline, Lilly, Pfizer, Wyeth, and/or

Bristol-Myers Squibb. "

 

Along these same lines, was the response of a high FDA official, Dr.

Sandra Kweder, who defended the safety of Vioxx in the midst of the

mounting body count, that deaths attributed to Vioxx were not " real

deaths. " She is quoted stating; " this isn't a cause for panic. For

many women, the small risk suggested by this study may be outweighed

by their own personal need for treatment of a mental health condition. "

 

Thus, industry's profit margins override the value judgments made by

America's medical elite-- medicine's precautionary first principle;

" First, do no harm, " has been banished from the risk/ benefit equation.

 

 

To paraphrase the late truly ethical, responsible psychiatrist, Dr.

Loren Mosher, an unholy alliance between drug manufacturers and

psychiatry's institutional leadership has derailed the profession from

its responsibility toward patients' best interests.

 

Indeed this unholy alliance has succeeded in saturating the

information channels with false and misleading drug infomercials

targeting both the public and treating doctors. Industry has widely

broadcast false assurances by psychiatry's key opinion leaders who

misstated the facts about safety. They bear equal responsibility for

the widespread misprescribing of antidepressants--even during pregnancy.

 

See a series of articles, mostly by the same authors who put a

positive spin on medical malpractice: JAMA:

http://jama.ama-assn.org/cgi/search?fulltext==wisner & submit.x==0 & submit.y==0 & sub\

mit==GO;

 

American Psychiatric Association not only recommends antidepressants

for pregnant depressed women, but recommends these drugs as

" prophylactic treatment: "

 

" Given the apparent safety of antidepressants and the possible adverse

effects of untreated depression, is prophylactic treatment warranted

during pregnancy and the postpartum period?

 

For women with a significant history of depression, the answer may be

yes. "

http://neuropsychiatryreviews.com/jun01/npr_jun01_antidepressants.html

 

Psychiatry ought to be held accountable for making false claims about

drug safety. There ought to be a law prohibiting licensed

professionals from prescribing hazrdous substances to pregnanct women

and children--without even informing them about the documented risks

the drugs pose.

 

Even an examination of the risks disclosed by manufacturers in these

drugs' labels should have raised alarm bells about widespread

prescribing of antidepressants--especially for children and pregnant

women whose intake of toxic substances injures their yet to be born

infants.

 

To make an informed decision, one must weigh the potential benefits

against the risks. To do so, one must know what the relative risks are.

 

See: http://www.ahrp.org/cms/content/view/71/28/

 

For those unaware about the risks listed in the labels of these

drugs--risks that were documented in controlled clinical trials, see

the following Adverse Event tables for the most widely prescribed

SSRIs--Prozac, Paxil and Zoloft. The adverse events (A-E) listed in

these drugs' labels show those A-Es that were reported during clinical

trials.

 

The Tables show the relative risk (% of A-E) in patients taking one of

these drugs compared to the relative risk for those on placebo.

 

We compiled a Table using the risk information disclosed in these

drugs' labels. Our table shows the adverse events that are listed for

any of these drugs in tables of adverse events (contained in the

drugs' label) for which the risk was greater for patients receiving

the drug than for patients receiving placebo. That is, the table

shows the excess risk (%) of the drug over and above the background

risk that occurred with placebo.

 

See: Benefits and Risks of SSRIs Above and Beyond Placebo:

Demonstrated in Short-Term Controlled Clinical Trials

http://ahrp.org/risks/SSRIrbTable.html

 

We also show the drugs' claimed benefit for depressed children--as

calculated by a Task Force of the American College of

Neuropsychopharmacology--from pediatric trials in depressed children.

Of note, ACNP members conducted many of the SSRI trials both before

their approval and post-marketing studies. See: ACNP Task Force Report

on SSRIs and Suicidal Behavior in Youth (2005)

http://www.nature.com/npp/journal/vaop/ncurrent/full/1300958a.html

 

We hope that our table provides information not otherwise available to

help physicians and parents to evaluate the benefit / risk ratio that

these drugs present for children and adolescents.

 

However, as news reports continue to disclose additional serious

risks--particularly risks for children and infants-risk reassessments

will, no doubt, be needed to ascertain the true overall risks posed by

psychoactive prescription drugs.

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

<http://content.nejm.org/content/vol354/issue6/index.shtml>

 

New England Journal of Medicine Volume 354:579-587 February 9, 2006

Selective Serotonin-Reuptake Inhibitors and Risk of Persistent

Pulmonary Hypertension of the Newborn

Christina D. Chambers, Ph.D., M.P.H., Sonia Hernandez-Diaz, M.D.,

Dr.P.H., Linda J. Van Marter, M.D., M.P.H., Martha M. Werler, Sc.D.,

Carol Louik, Sc.D., Kenneth Lyons Jones, M.D., and Allen A. Mitchell, M.D.

 

ABSTRACT

 

Background Persistent pulmonary hypertension of the newborn (PPHN) is

associated with substantial infant mortality and morbidity. A previous

cohort study suggested a possible association between maternal use of

the selective serotonin-reuptake inhibitor (SSRI) fluoxetine late in

the third trimester of pregnancy and the risk of PPHN in the infant.

We performed a case-control study to assess whether PPHN is associated

with exposure to SSRIs during late pregnancy.

 

Methods Between 1998 and 2003, we enrolled 377 women whose infants had

PPHN and 836 matched control women and their infants. Maternal

interviews were conducted by nurses, who were blinded to the study

hypothesis, regarding medication use in pregnancy and potential

confounders, including demographic variables and health history.

 

Results Fourteen infants with PPHN had been exposed to an SSRI after

the completion of the 20th week of gestation, as compared with six

control infants (adjusted odds ratio, 6.1; 95 percent confidence

interval, 2.2 to 16.8). In contrast, neither the use of SSRIs before

the 20th week of gestation nor the use of non-SSRI antidepressant

drugs at any time during pregnancy was associated with an increased

risk of PPHN.

 

Conclusions These data support an association between the maternal use

of SSRIs in late pregnancy and PPHN in the offspring; further study of

this association is warranted. These findings should be taken into

account in decisions as to whether to continue the use of SSRIs during

pregnancy.

 

Source Information

 

From the Departments of Pediatrics (C.D.C., K.L.J.) and Family and

Preventive Medicine (C.D.C.), University of California, San Diego, La

Jolla; the Slone Epidemiology Center, Boston University School of

Public Health, Boston (S.H.-D., M.M.W., C.L., A.A.M.); and Children's

Hospital and Brigham and Women's Hospital, Harvard Medical School,

Boston (L.J.V.M.).

 

Address reprint requests to Dr. Chambers at the University of

California, San Diego, Medical Center, 200 W. Arbor Dr., Mail Code

8446, San Diego, CA 92103, or at chchambers .

 

The New England Journal of Medicine is owned, published, and

copyrighted © 2006 Massachusetts Medical Society

<http://www.massmed.org/> . All rights reserved.

 

~~~~~~~~~~~~~

 

 

http://www.psycport.com/stories/knightridder_2006_02_09_krtbn_0000-0017-GL-ANTID\

EPRESS-20060209.xml.html

FDA considers new warning on labels of antidepressants

The Boston Globe - February 09, 2006

Feb. 9--WASHINGTON -- The Food and Drug Administration is again

considering revising labels of popular antidepressants, this time in

response to an article in today's New England Journal of Medicine that

linked use of drugs like Paxil, Prozac, and Zoloft late in pregnancy

with a condition that can endanger infants' lives.

 

During a hastily called press conference yesterday, the FDA called the

results of a study cited in the article " very concerning. "

 

The agency will issue a public health advisory within days, said Dr.

Sandra Kweder, deputy director of the FDA's Office of New Drugs. Its

regulatory options include updating drug labels, searching public and

private databases to corroborate the drug link to the lung condition,

and requiring additional trials from drug manufacturers.

 

But because the condition -- persistent pulmonary hypertension of the

newborn -- is rare and failure to treat maternal depression can cause

its own problems, the study's lead author does not expect the FDA to

follow the lead of Canadian regulators, who warned against using

new-generation antidepressants during pregnancy.

 

In October 2004, the FDA told manufacturers to add warnings on boxes

alerting patients that the antidepressants increase suicidal thoughts

and behaviors in children taking them. Last December it warned of an

association between Paxil and heart defects when the drug is taken

early in pregnancies.

 

The study described in the Journal article was observational and

included interviews with 1,200 women within six months of giving

birth. It is unethical to give pregnant women experimental drugs to

gauge birth defect risks.

 

" This is an approach to looking at all medications that pregnant women

might take and doing it in a systematic, consistent fashion so that we

don't wait years to find out if a drug might cause a problem, " said

Christina Chambers, the study's lead author and director of a

California program that fields 8,000 calls annually about the safety

of medicines for developing fetuses.

 

Up to 15 percent of women of reproductive age suffer major depressive

disorders. The study focused on new-generation antidepressants called

selective serotonin reuptake inhibitors. They were the nation's fifth

highest selling class of prescription drugs in the first nine months

of 2005, accounting for 122.6 million prescriptions, according to IMS

Health a pharmaceutical market research firm. About 3 percent of women

take that type of antidepressant at some point during pregnancy.

 

Normally, one to two newborns per 1,000 suffer from persistent

pulmonary hypertension, which means their pulmonary arterial pressure

is too high at birth. As a result, their lungs can't provide enough

oxygen, causing their bodies to produce oxygen-poor blood and

sometimes resulting in death. In one study, nearly half the survivors

were cognitively delayed, had major neurological problems, and could

not hear.

 

When pregnant women took selective serotonin reuptake inhibitors after

20 weeks gestation, the risk of their infants developing persistent

pulmonary hypertension rose sixfold, to about one in 100 newborns. The

study size was too small to determine whether one antidepressant was

riskier than another. " This is the latest in a series of troubling

reports of possible adverse events " of selective serotonin reuptake

inhibitors on fetuses, Dr. James Mills of the National Institutes of

Health wrote in an accompanying editorial in the Journal.

 

Previous studies linked the antidepressants with infants' rapid

breathing, jitteriness, bluish skin color from lack of oxygen,

difficulty nursing, and low blood sugar.

 

The FDA said it does not want pregnant women to stop medication

without consulting both their obstetricians and doctors providing

their mental healthcare. " This isn't a cause for panic, " the FDA's

Kweder said. " The risk is small enough that 99 percent of women's

babies who are taking these medicines would not be at risk. "

 

To see more of The Boston Globe, or to to the newspaper, go

to http://www.boston.com/globe. Copyright © 2006, The Boston Globe

 

Distributed by Knight Ridder/Tribune Business News.

 

http://www.nytimes.com/2006/02/09/national/09depress.html?ex=40152400 & en=¢309f2\

b552af81e & ei=P70 & emc==eta1

THE NEW YORK TIMES

February 9, 2006

Antidepressants May Harm Infants' Lungs, Report Says

By BENEDICT CAREY

Expectant mothers who took antidepressants like Prozac late in their

pregnancy were significantly more likely to give birth to an infant

with a rare but serious breathing problem, doctors are reporting today.

 

The lung disorder, called persistent pulmonary hypertension, strikes 1

to 2 newborns in 1,000, on average, and can be fatal. In babies

exposed to antidepressants during the last few months of pregnancy,

the study found, the rate was six times as high: 6 to 12 newborns in

1,000.

 

In a news conference yesterday, Dr. Sandra L. Kweder, an official at

the Food and Drug Administration, which was not involved in the

research, said that the study results were " very worrisome, " and that

the agency planned to search its own database of adverse events for

further evidence of risk. She said the F.D.A. would consider whether

to require manufacturers to make labeling changes and conduct

postmarketing studies to clarify the risk.

 

The findings, published today in The New England Journal of Medicine,

are the latest in a series of reports that highlight the tough choices

that face millions of women with depression who are pregnant or plan

to be. Untreated maternal depression can also harm a developing fetus,

experts say, and last week researchers reported in a study that 68

percent of pregnant women who quit taking antidepressants relapsed,

compared with 26 percent of those who stayed on the drugs.

 

But studies have found that up to one-third of babies exposed to

antidepressants in the womb suffer temporary withdrawal symptoms like

agitation. The F.D.A. has warned that one popular depression drug,

Paxil, from GlaxoSmithKline, may increase the risk of rare heart

problems in newborns exposed to the medication in utero.

 

" It's very important to get across that we don't know for certain that

the drugs actually caused persistent pulmonary hypertension, and that

if they did, the risk is still low, about one in a hundred, " said the

new study's lead author, Dr. Christine Chambers, an assistant

professor of pediatrics at the University of California, San Diego,

who worked with researchers from Boston University and Harvard. " But

women should be informed. "

 

Psychiatrists estimate that 10 percent to 15 percent of pregnant women

suffer bouts of depression, and at least 1 in 10 of those take

antidepressants. Between 1998 and 2003, the research team interviewed

377 women who had recently given birth to a baby with persistent

pulmonary hypertension, asking about medical history and drugs taken

during pregnancy. The researchers found that 3.7 percent of the

infants had been exposed to commonly prescribed antidepressants after

the 20th week of pregnancy, about six times the rate among infants in

a comparison group of healthy babies born at the same time.

 

The antidepressants belong to a class of drugs that acts in the brain

to prolong the action of a mood-related messenger chemical called

serotonin. They included Celexa, from Forest Laboratories; Zoloft,

from Pfizer; Paxil; and Prozac, from Eli Lilly.

 

In their paper, the researchers argue that the drugs may hinder the

body's production of agents that help blood vessels dilate. If the

vessels in a newborn's lungs do not open properly, they cannot absorb

sufficient oxygen, and the body may reflexively hold its breath,

further starving itself of air, doctors say. Giving an infant oxygen,

or nitric oxide, which helps open vessels, often relieves the problem.

An estimated 10 percent to 20 percent of cases are severe enough that

doctors may connect an affected child to an artificial lung.

 

Obstetricians, psychiatrists and pediatricians agree that pregnant

women taking the drugs should consult their doctors to decide how to

proceed. Stopping antidepressant therapy can cause withdrawal effects

as well as relapse, they say.

 

Dr. Timothy Oberlander, a developmental pediatrician at the University

of British Columbia, said that the new study added to a small but

growing literature that was helping clarify the risks of specific

drugs taken during pregnancy.

 

" You're talking about small numbers here, but it's clear that there

are a group of babies that have more side-effects from exposure to

these drugs than most, " Dr. Oberlander said, " and women need to weigh

this against the risk of untreated depression, which not only affects

the mother but the context in which the child is raised. "

 

Copyright 2006The New York Times Company

 

 

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