Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs

scotty · 02-08-2006, 09:12 PM

I was made aware of this in a meeting that I went to tonight. 1-100.. small risk?? This is absolutely terrifying!!! This condition is present "normally" 1-1000!!

http://www.webmd.com/content/article/118/113028.htm

Pregnancy Antidepressants: Baby Risk

Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs
By Daniel DeNoon
WebMD Medical News Reviewed By Louise Chang, MD
on Wednesday, February 08, 2006

Feb. 8, 2006 -- Babies whose mothers took antidepressant drugs in the
second half of pregnancy are six times more likely to have a rare but
dangerous lung ailment, a new study suggests.

One study isn't proof. But it's strong evidence that taking SSRI
antidepressants -- such as Prozac, Zoloft, and Paxil -- carries an
extra risk during pregnancy.

The risk is that the babies will have PPHN: persistent pulmonary
hypertension of the newborn. Only one or two in a thousand babies get
this, but it's very serious. It kills about one in 10 babies who get
it. In moderately severe cases, half the survivors suffer hearing loss
or brain damage.

"We find these results very concerning," Sandra L. Kweder, MD, deputy
director of the FDA's office of new drugs, said in an unusual, hastily
called news conference. "We find the reported association of SSRI
antidepressants with this very serious condition to be very worrisome."

This does not mean that pregnant women with clinical depression should
forgo treatment, says researcher Christina Chambers, PhD, MPH, of the
University of California, San Diego. Chambers is program director of
the California Teratogen Information Service. CTIS conducts pregnancy
outcomes research and offers women information about the pregnancy
risks of drugs and chemicals.

"This is a fairly low risk for women taking SSRI antidepressants,"
Chambers tells WebMD. "So if in fact SSRIs cause PPHN, the risk appears
to be low. For 100 women taking one of these medications late in
pregnancy, only one may have a child with PPHN."

"This isn't a cause for panic among pregnant women taking these
medicines," the FDA's Kweder says. "This is the kind of information a
woman should discuss with her doctors -- not just her obstetricians but
also the doctor providing her mental health care. Stopping these
medicines on your own can create more problems than it solves. The
small risk that is being reported here may well be outweighed by your
need for a medicine to treat your depression."

The study appears in the Feb. 9 issue of The New England Journal of
Medicine.

FDA Advisory

Kweder says the FDA is taking a hard look at Chambers' findings. She
says the FDA will issue a public-health advisory in the next few days.

"We are in the process of evaluating the Chambers article further,"
Kweder explains. "We will look at our Adverse Event Reporting System
and other databases to see if we have any data to add to this."

Kweder says the FDA may ask antidepressant makers to add a warning to
their labels. The agency may also ask the companies to conduct new
surveys of pregnant women who use or have used their products, she
notes.

rdjanis · 02-08-2006, 10:10 PM

This is horrible!!

sherijo · 02-08-2006, 10:26 PM

oh my good ness.. when are these people going to STOP minimizing! GEEZ!

i bet that neither of the people who wrote the article were pregnant.. lets knock them up and force feed them paxil.. and see what they think then!

sheri

Katesmom · 02-08-2006, 10:26 PM

So glad that they site all SSRIs and not just one, so people don't just switch while pregnant.

This really puts pregnant SSRI users in a bind. If they have an unplanned pregnancy while on the meds, they probably won't even see a doc before it's "too late" to deal with the potential fetal heart damage. Now they have to taper off before half-way through their pregnancy--so what like 18-20 weeks. That gives them about ten weeks to completely taper! And the whole time they'll be wondering if it's too little too late.

I would say that this means that SSRIs should be contraindicated for use in women who might become pregnant, but I've seen the ads and that's the target demo, so what are the chances?

scotty · 02-08-2006, 10:50 PM

It's now reached the point, IMO, that these drugs need to be prescribed just like Accutane. The patient must use birth control before starting them.A black box warning MUST be placed and the patient MUST be made aware of these risks. The fact that we now have cardiac abnormality, withdrawal and now pulmonary hypertension if the FDA does nothing that will tell the tale. They haven't even started looking for later developmental problems for kids exposed to paxil. For those who are pregnant now and on them, I have NO idea what the right answer is. There is no good answer once the pregancy has started.

This has me SO pissed off you can't even imagine!

elisa · 02-08-2006, 11:06 PM

For 100 women taking one of these medications late in
pregnancy, only one may have a child with PPHN."

In the medical community, 1 out of 100 suffering side-effects is considered frequent.

The words "only one " (out of a hundred) are absolutely unacceptable!!

scotty · 02-08-2006, 11:13 PM

I'm waiting for "my" newspapers coverage tomorrow. I've been told that they are covering it.

elisa · 02-08-2006, 11:24 PM

Quote:

Originally Posted by scotty

I'm waiting for "my" newspapers coverage tomorrow. I've been told that they are covering it.

Excellent Laurie!! These meds are deadly.....

Not only should the label state it in bold on the black box, but also the the word frequent side-effect should be stated.

scotty · 02-09-2006, 11:55 AM

http://content.nejm.org/cgi/content/short/354/6/579

punky · 02-09-2006, 12:31 PM

I just got this email in my box from drugawareness.org It is absolutely horrific! I remember my doc suggesting i get put on paxil during my pregnancy because i was in nursing school and totally having a hard time of it. I am so glad i passed up on it at that time!

Katesmom · 02-09-2006, 01:06 PM

Quote:

Originally Posted by scotty

This has me SO pissed off you can't even imagine!

Oh, yes, believe me, I can!

02-09-2006, 03:50 PM

A little bit off topic but i was watching BBC World news last night and JP garnier was being interviewed about Glaxos new Anti bird flu drug ....

Seems the propaganda never ends ....

RR · 02-10-2006, 07:29 AM

Quote:

Originally Posted by Redking

A little bit off topic but i was watching BBC World news last night and JP garnier was being interviewed about Glaxos new Anti bird flu drug ....

Seems the propaganda never ends ....

It's only Glaxo's PR offensive trying to get out ahead of Michael Moore's upcoming movie.

02-10-2006, 09:13 AM

Well , i hope that Michael Moore does a segment on Paxil ...

02-08-2006, 09:12 PM	#1
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 47,001	Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs I was made aware of this in a meeting that I went to tonight. 1-100.. small risk?? This is absolutely terrifying!!! This condition is present "normally" 1-1000!! http://www.webmd.com/content/article/118/113028.htm Pregnancy Antidepressants: Baby Risk Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs By Daniel DeNoon WebMD Medical News Reviewed By Louise Chang, MD on Wednesday, February 08, 2006 Feb. 8, 2006 -- Babies whose mothers took antidepressant drugs in the second half of pregnancy are six times more likely to have a rare but dangerous lung ailment, a new study suggests. One study isn't proof. But it's strong evidence that taking SSRI antidepressants -- such as Prozac, Zoloft, and Paxil -- carries an extra risk during pregnancy. The risk is that the babies will have PPHN: persistent pulmonary hypertension of the newborn. Only one or two in a thousand babies get this, but it's very serious. It kills about one in 10 babies who get it. In moderately severe cases, half the survivors suffer hearing loss or brain damage. "We find these results very concerning," Sandra L. Kweder, MD, deputy director of the FDA's office of new drugs, said in an unusual, hastily called news conference. "We find the reported association of SSRI antidepressants with this very serious condition to be very worrisome." This does not mean that pregnant women with clinical depression should forgo treatment, says researcher Christina Chambers, PhD, MPH, of the University of California, San Diego. Chambers is program director of the California Teratogen Information Service. CTIS conducts pregnancy outcomes research and offers women information about the pregnancy risks of drugs and chemicals. "This is a fairly low risk for women taking SSRI antidepressants," Chambers tells WebMD. "So if in fact SSRIs cause PPHN, the risk appears to be low. For 100 women taking one of these medications late in pregnancy, only one may have a child with PPHN." "This isn't a cause for panic among pregnant women taking these medicines," the FDA's Kweder says. "This is the kind of information a woman should discuss with her doctors -- not just her obstetricians but also the doctor providing her mental health care. Stopping these medicines on your own can create more problems than it solves. The small risk that is being reported here may well be outweighed by your need for a medicine to treat your depression." The study appears in the Feb. 9 issue of The New England Journal of Medicine. FDA Advisory Kweder says the FDA is taking a hard look at Chambers' findings. She says the FDA will issue a public-health advisory in the next few days. "We are in the process of evaluating the Chambers article further," Kweder explains. "We will look at our Adverse Event Reporting System and other databases to see if we have any data to add to this." Kweder says the FDA may ask antidepressant makers to add a warning to their labels. The agency may also ask the companies to conduct new surveys of pregnant women who use or have used their products, she notes. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

02-08-2006, 10:10 PM	#2
rdjanis "has a lavender scented keyboard" Join Date: Mar 2004 Location: Ontario Posts: 22,214	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs This is horrible!! __________________ Rita

02-08-2006, 10:26 PM	#3
sherijo Banned Join Date: Nov 2005 Location: chicago, illinois Posts: 1,357	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs oh my good ness.. when are these people going to STOP minimizing! GEEZ! i bet that neither of the people who wrote the article were pregnant.. lets knock them up and force feed them paxil.. and see what they think then! sheri

02-08-2006, 10:26 PM	#4
Katesmom Join Date: Jul 2005 Location: Texas Posts: 13,812	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs So glad that they site all SSRIs and not just one, so people don't just switch while pregnant. This really puts pregnant SSRI users in a bind. If they have an unplanned pregnancy while on the meds, they probably won't even see a doc before it's "too late" to deal with the potential fetal heart damage. Now they have to taper off before half-way through their pregnancy--so what like 18-20 weeks. That gives them about ten weeks to completely taper! And the whole time they'll be wondering if it's too little too late. I would say that this means that SSRIs should be contraindicated for use in women who might become pregnant, but I've seen the ads and that's the target demo, so what are the chances? __________________ Katesmom aka Kim started Paxil Oct. 2003 for PIH Paxil free since 19 Jul 2005 ". . .the cruelest lies are often told without a word. . .the kindest truths are often spoken, never heard." -- Ben Folds

02-08-2006, 10:50 PM	#5
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 47,001	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs It's now reached the point, IMO, that these drugs need to be prescribed just like Accutane. The patient must use birth control before starting them.A black box warning MUST be placed and the patient MUST be made aware of these risks. The fact that we now have cardiac abnormality, withdrawal and now pulmonary hypertension if the FDA does nothing that will tell the tale. They haven't even started looking for later developmental problems for kids exposed to paxil. For those who are pregnant now and on them, I have NO idea what the right answer is. There is no good answer once the pregancy has started. This has me SO pissed off you can't even imagine! __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

02-08-2006, 11:06 PM	#6
elisa Join Date: Jul 2004 Location: Ontario, Canada Posts: 11,473	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs For 100 women taking one of these medications late in pregnancy, only one may have a child with PPHN." In the medical community, 1 out of 100 suffering side-effects is considered frequent. The words "only one " (out of a hundred) are absolutely unacceptable!! __________________ On A/D's since 1995, switching due to side-effects on 30 different brands of TCA's, SSRI's, SNRI's, Antipsychotics, Benzo's & Imovane. 6 ECT's. Tapering from 225 mg Effexor XR May 17, 2004. (Equiv. to 60 mg Paxil) Last taper Effexor XR Jan 17, 2006 down to ZERO. Currently protracted withdrawal. Sept 2006: 25 mg Doxepin. March 13/09: 10 mg Desipramine Last edited by elisa : 02-08-2006 at 11:20 PM.

02-08-2006, 11:13 PM	#7
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 47,001	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs I'm waiting for "my" newspapers coverage tomorrow. I've been told that they are covering it. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

02-09-2006, 11:55 AM	#9
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 47,001	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs http://content.nejm.org/cgi/content/short/354/6/579 __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

02-09-2006, 12:31 PM	#10
punky Join Date: Jan 2006 Location: North Carolina Posts: 832	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs I just got this email in my box from drugawareness.org It is absolutely horrific! I remember my doc suggesting i get put on paxil during my pregnancy because i was in nursing school and totally having a hard time of it. I am so glad i passed up on it at that time! __________________ 7/00-1/1/06 Paxil 20-40mg 1/2-2/18 Paxil CR 25mg 2/19-5/3 Paxil CR 12.5mg 5/4-5/9 Paxil CR 25mg 5/10-5/15 Paxil CR 12.5mg 5/16-6/10 Paxil CR 10mg 6/11-7/13 Paxil CR 6.25mg 7/13-7/31 Paxil CR 3mg 8/1-9/5 Paxil CR 6.25mg 9/6 to 9/11 Paxil 10mg/5ml Suspension 5mg (2.5ml) 9/12 to present Paxil 10mg/5ml Suspension 7mg (3.5ml)

02-09-2006, 03:50 PM	#12
Redking Posts: n/a	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs A little bit off topic but i was watching BBC World news last night and JP garnier was being interviewed about Glaxos new Anti bird flu drug .... Seems the propaganda never ends ....

02-10-2006, 09:13 AM	#14
Redking Posts: n/a	Re: Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs Well , i hope that Michael Moore does a segment on Paxil ...

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