Re: SSRIs and Neonates, Fetuses

November 17, 2004

Here's a mishmash of articles, which may help you. The Health Canada

advisory is at the very bottom.

http://content.nejm.org/cgi/content/short/335/14/1010

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Paroxetine withdrawal syndrome in a neonate. Br J Psychiatry. 1997

Oct;171:391-2 Dahl, Olhager, Ahlner.

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http://archpedi.ama-assn.org/cgi/content/abstract/158/4/312

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This is a letter I wrote to some jackass at some university who said it was

perfectly safe to take SSRIs while pregnant.

Dear Dr. Stowe:

>

> I came across this poignant story of a woman who took SSRIs while

> pregnant. Her baby had a bilateral stroke in utero. The next time

> you tout Paxil-Prozac-Zoloft-etal as being safe during pregnancy, I

> hope you will think about what this poor baby went through because

> some ignorant doctor believed the propaganda spewed by the legal Drug

> Cartel. How DO you monsters sleep at night? Using our pediatric

> population, including unborn children, as human guinea pigs for SSRI

> drugs will be the subject of my next book. You can expect to be

> quoted in it.

>

> From: The Greene House

> Sent: Thursday, September 26, 2002 8:58 AM

> [email PROTECTED]

> Subject: PSNLoop Paxil

>

> Hi, I have a personal question for everyone; was anyone taking the SSI

> uptake drug Paxil during their pregnancy? If so, please email me at

> [email PROTECTED] Here's why:

>

> I was on Paxil when I got pregnant (accidental pregnancy, I was told I

> couldn't conceive), but I stopped taking it when I found out I was

> pregnant,

> although both my primary physician and my OBGYN said that is was OK

> to take.

> My gut feeling said to go off of it, so I did; that is until I was 7

> days

> overdue and decided that my anxiety was probably going to be very bad

> after

> the baby was born, so on March 10th, 2001 I began to take Paxil

> again. Well,

> on March 11th, 2001 the baby was kicking non-stop the whole day. I

> called

> the OB and he said to wait and go for my already scheduled non-stress

> test

> on March 12. The ultrasound didn't show any problems, so they sent me

> home.

> That night I started to go into labor, and the next day at 9:52 am

>

> was born via C-section because I wasn't progressing. He then had

> seizures

> and was immediately sent to Children's Hospital who determined that

> he had a

> stroke w/in 72 hours of birth. THE SAME TIME I STARTED TO TAKE PAXIL

> AGAIN.

>

> I've been doing so research on the drug (too little too late as they

> say)

> and found that other's ADULTS have had a stroke while on the drug.

> California has a class action suit out against the drug's maker, but

> for

> other reasons than stroke.

>

> So, I was just curious if anyone else was taking Paxil during

> pregnancy and

> then their child had a stroke in utero. I can't prove that Paxil

> caused

> 's stroke, but if anyone else has a similar situation, maybe we

> can

> let the drug maker know and prevent this from happening to other

> families.

>

> Jackie, Mom to , 18 months old, bilateral stroke in utero

>

--------------------------

Pediatric Subcommittee To Consider Neonatal Antidepressant Withdrawal June 9

FDA's Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee

will advise the agency on the best methods of informing the public and

practitioners about neonatal withdrawal syndromes following gestational

antidepressant exposure during its June 9 meeting.

The pediatric subcommittee is scheduled to discuss neonatal withdrawal

following exposure to serotonin reuptake inhibitors or selective

norepinephrine reuptake inhibitors.

The subcommittee will also provide guidance on research needs in the area of

neonatal antidepressant withdrawal.

Subcommittee members have been provided with nine journal articles on

withdrawal covering such topics as the risks of neurobehaviorial outcomes in

babies born to treated mothers, the benefits of discontinuing therapy in

pregnant women and the appropriate treatment of neonatal SSRI withdrawal.

The main part of the meeting will feature presentations of pediatric adverse

event reports for Aventis' Allegra (fexofenadine), GlaxoKline's

Hycamtin (topotecan), Schering-Plough's Temodar (temozolomide), Alcon's

Vigamox (moxifloxacin) and Ciloxan (ciprofloxacin), Bristol-Myers Squibb's

Monopril (fosinopril) and Alza's Duragesic (fentanyl transdermal patch) and

Effexor (venlafaxine).

The reports will cover the first year of marketing following the granting of

pediatric exclusivity.

In addition, the subcommittee will hear updates on congenital eye

malformation in infants and on the Pediatric Research Equity Act, plus an

overview of an Institute of Medicine report entitled " Ethical Conduct of

Clinical Research Involving Children. "

-----------------------

2004-44

August 9, 2004

For immediate release

http://www.hc-sc.gc.ca/english/protection/warnings/2004/2004_44.htm

Advisory

" Health Canada advises of potential adverse effects

of SSRIs and other anti-depressants on newborns "

OTTAWA - Health Canada is advising Canadians that newborns may be

adversely affected when pregnant women take Selective Serotonin Re-uptake

Inhibitors (SSRIs) and other newer anti-depressants during the third

trimester of pregnancy. This advisory is intended to increase awareness

among mothers and physicians of the possible symptoms that may occur in

the newborn, so that symptoms can be recognized and addressed quickly.

This advisory applies to the following anti-depressants: bupropion

(whether used for depression or for smoking cessation), citalopram,

fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline and

venlafaxine.

International and Canadian reports reveal that some newborns whose

mothers took these medications during pregnancy have developed

complications at birth requiring prolonged hospitalization, breathing

support and tube feeding. Reported symptoms include: feeding and/or

breathing difficulties, seizures, muscle rigidity, jitteriness and

constant crying. In most cases, the newer anti-depressant was taken

during the third trimester of pregnancy. These symptoms are consistent

with either a direct adverse effect of the anti-depressant on the baby,

or possibly a discontinuation syndrome caused by sudden withdrawal from

the drug.

When treating depression in pregnant women, physicians and patients

should carefully consider the potential risks and benefits of the various

treatment options for both the mother and the unborn baby. To date, there

is little evidence-based information on how best to treat depression

during pregnancy.

If a woman is pregnant and is taking an SSRI, or other newer

anti-depressant, she should discuss with the risks and benefits of the

various treatment options with her health care professional. It is very

important that patients do NOT stop taking these medications without

first consulting with their doctor.

The frequency of symptoms may vary with each drug. In the case of two of

the newer anti-depressants - bupropion and mirtazapine - discontinuation

problems appear to be less than with the other drugs. In the case of

mirtazapine, there are only two reports. Health Canada is issuing this

advisory to encompass all newer anti-depressants in order to alert

Canadians to the potential risk. Health Canada has also worked with the

manufacturers of these medications to update their labelling with new

precaution information.

Any suspected adverse reactions can be reported directly to the product

manufacturer or to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Marketed

Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consumers and health professionals may

call toll free:

Tel: 866 234-2345

Fax: 866 678-6789

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines

can be found on the Health Canada web site or in The Canadian Compendium

of Pharmaceuticals and Specialties.

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html

Early Exposure to Prozac May Up Anxiety RiskTuesday, October 26, 2004By

Salynn BoylesNew research is raising more concerns about the safety of the most

widely prescribed antidepressants (search) in pregnant women and young children.

A new study of mice suggests that early exposure to drugs like Prozac could

increase the chances of developing depression and anxiety disorders later in

life.Columbia University researchers found that mice exposed to Prozac shortly

after birth exhibited abnormal emotional behavior in adulthood that appeared to

result from a drug-related disruption of a key growth factor linked to brain

development.The findings were made public Tuesday at the annual meeting of the

Society for Neuroscience in San Diego. They will also be published in the Oct.

29 issue of the journal Science.Earlier this month, the FDA ordered drug

manufacturers to include warnings on the packaging of Prozac and similar drugs

about a possible increased risk of suicidal thoughts or behaviors among children

and adolescents who take them. These depression drugs, called selective

serotonin reuptake inhibitors (search) (SSRIs), include Prozac, Celexa (search),

and

Zoloft, (search) and several others.The latest study offers more evidence

that the drugs may not be as safe as once thought, although its researchers

point

out that the relevance of the findings in humans is not known. " We are hoping

that this work will serve as impetus for doing the kind of clinical studies

necessary to find out if there are long-term risks associated with these drugs, "

Columbia University psychiatry professor Jay A. Gingrich, MD, PhD, tells

WebMD.Stressed-Out RodentsSSRIs work by inhibiting the absorption of the brain

chemical serotonin by the serotonin transporter 5-HTT.Earlier studies in animals

have identified serotonin as a key growth factor for brain development.In the

newly published study, the Columbia University researchers examined the

effects of SSRI exposure in mice at a period in life that corresponded roughly

to

the last trimester of pregnancy through age 8 in humans.As expected, mice

lacking the 5-HTT gene exhibited abnormally high anxiety levels as adults, with

or

without early exposure to Prozac.Mice with the intact gene who had no

early-life exposure to Prozac exhibited normal anxiety levels as adults.However,

mice

with the intact 5-HTT gene who were exposed to Prozac as newborns behaved more

like the 5-HTT gene-deficient mice. They showed abnormally high anxiety

levels.More Study NeededThe researchers conclude that by blocking the absorption

of

serotonin, Prozac may stimulate the abnormal activation of several other

receptors in the developing brain, leading to abnormal development. " These are

mice,

so we don't know what the impact is on the developing human brain, " Gingrich

says. " But if there has been a trend toward complacency in prescribing these

drugs and a thinking that they carry no risks for pregnant women and young

children, this is something new to consider. " Emory University psychiatry

professor

Plotsky, PhD, is also studying the effects of early SSRI exposure on

brain development. Preliminary data from his own research in mice suggests that

repeatedly going on and off SSRIs while the brain is still developing may lead

to bipolar disorder.In another study, the researcher found that 6-month-old

babies born to mothers taking SSRIs exhibited higher than normal anxiety levels

during physical exams. " These drugs have been thought to be safe because there

is no overt evidence that they are not, but they could be driving subtle

changes in the brain and basically building in risk factors for psychological

problems, " he tells WebMD. " But depression is also very dangerous, so it is

important that we understand the risks and benefits of these drugs. " Tallie

Baram, MD,

PhD, calls the new findings compelling but says there needs to be further

study. Baram is a professor of psychiatry at the University of California,

Irvine. " The fact that they found this in mice is an eye opener, " she says. " But

there is still a lot of work to be done to understand its relevance. " By Salynn

Boyles, reviewed by Brunilda Nazario, MDSOURCES: Ansorge et al. Science, Oct.

29,

2004; pp 879-881. Neuroscience 2004, San Diego, Oct. 23-27, 2004. Jay A.

Gingrich, MD, PhD, department of psychiatry, Columbia University College of

Physicians and Surgeons, New York. Plotsky, PhD, professor, department of

psychiatry, Emory University, Atlanta. Tallie Baram, MD, PhD, professor of

psychiatry, University of California, Irvine.

" Blind Reason "

a novel of pharmaceutical intrigue

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November 17, 2004