The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Zoloft Frequently Causes Heart Defects in Babies: BMJ

Another study (this time in the BMJ) finds an increased risk in heart defects, the severity of the risk depending on which SSRI you took. I see no mention of Paxil, which is curious in and of itself. (See: Paxil more powerful teratogen than Cocaine, court documents from the first Paxil birth defect trial, and other related articles concerning this trial on the Seroxat Sufferers blog. By the way, thanks to Fiddy for embedding our @pledgie “Stop Preventable Infant Deaths and Birth Defects” link!)

Also they seem anxious to let other birth defects off the hook and to regard not using SSRIs as not getting treatment. That’s ridiculous considering antidepressants can barely be considered to work at all and that they can actually make you worse and induce violence. How well do they work when your baby dies because of them? Are you supposed to feel happy if you keep taking your drugs?

This study seems to indicate that “about two” babies per 250 women who took an SSRI were born with a heart defect. I assume (though I haven’t read the study yet) that nobody looked at the heart defects leading to abortions or that they were not thinking about the babies who had so many other defects that they died in utero or after birth from some sort of “syndrome.” Probably like in other studies they would have excluded those babies with genetic problems that were linked to heart defects and multiple other defects, without considering if the rate of genetic defects was higher in the SSRI exposed group. If you don’t count all the miscarried babies either and you try to look at each individual type of heart defect and birth defect separately you can pretend the risk is small. But if you group all the risks together the supposed benefit pales in comparison to the risk. We know that antidepressants usually work about as well as a placebo (about one third of people showing mild improvement). But we also know that one third of women who expose their babies to antidepressants have a baby who is born early or underweight, who has seizures, or who dies (“women who take SSRIs have an increased risk of giving birth to a fetus who dies, having a premature delivery, giving birth to an underweight baby, and delivering babies who experience seizures. According to the study almost one-third of women on SSRIs experienced at least one of the complications”). So think about all the risks you would be exposing your baby to and then ask yourself if that’s depressing.

According to just this study, on average about two out of every 250 women taking SSRIs had a baby with a heart defect, compared to about one out of 250 who did not take SSRIs. But the same study said that the risk was more than three times higher with Zoloft than the non-exposed group, more than doubled with Celexa, and almost five times higher with more than one SSRI.

“Sertraline more than tripled the risk, while citalopram more than doubled it. Using more than one SSRI nearly quintupled the risk of the heart defect.”

According to the drug label, 1/100 to 1/1000 is an “infrequent” event, and fewer than 1/1000 is a “rare” event. “Frequent” means it occurs in at least 1/100 patients or more.

Two out of 250 is the same as .8 people per 100, or .008. That’s pretty close to bordering on the drug companies’ version of “frequent.” It’s definitely not in the rare category. But with Sertraline (Zoloft) it would be .012 or 1.2 babies per 100 babies, well into the frequent reaction zone. This is just one study and it’s hard to say without having read the whole thing how they came up with their results or what type of heart defect they looked at. I will update more later as I have time to do more research.

To see reports to the FDA of birth defects and deaths with psychiatric drug exposure go here: http://www.cchrint.org/psychdrugdangers/MothersAct.html

See Dr. Tracy’s commentary on the drugawareness.org website here.

http://www.reuters.com/article/healthNews/idUSTRE58O39F20090925

Antidepressants in pregnancy up heart defect risk

Fri Sep 25, 2009 9:58am EDT

By Anthony J. Brown, MD

NEW YORK (Reuters Health) – If you take antidepressants such as fluoxetine (marketed as Prozac) early in your pregnancy, you may be doubling the risk that your newborn will be born with a heart defect, according to a new study.

However, the vast majority of children born to women who take such antidepressants – known as selective serotonin reuptake inhibitors (SSRIs) – do not have such defects, the researchers are quick to note.

Earlier studies have tied SSRIs during pregnancy to heart defects, but also to even more serious birth defects. According to the new study of nearly half a million children born in Denmark between 1996 and 2003, however, only heart defects are likely to be associated with the antidepressants, note co-author Dr. Lars Henning Pedersen, from Aarhus University, Denmark, and colleagues.

Along with fluoxetine, sertraline (marketed as Zoloft) and citalopram (marketed as Celexa) seemed to increase the risk more than others, as did using more than one antidepressant at a time, according to the report in the September 25th Online First issue of BMJ.

Overall, SSRI use in early pregnancy, defined as 28 days before to 112 days after conception, doubled the risk of a particular kind of heart defect involving a piece of tissue that separates parts of the heart.

Sertraline more than tripled the risk, while citalopram more than doubled it. Using more than one SSRI nearly quintupled the risk of the heart defect.

However, the number of children born with such defects was still quite small: For about every 250 pregnant women who did not take SSRIs, one infant was born with the defect, while about two were born with the defect for every 250 women who took one SSRI, and four for every 200 mothers who took more than one.

Pedersen told Reuters Health that the results surprised the team.

Still, in an accompanying editorial, Dr. Christina Chambers, from the University of California, San Diego, comments that doctors and patients “need to balance the small risks associated with SSRIs against those associated with undertreatment or no treatment.”

SOURCE: BMJ, online September 25, 2009.

Filed under: antidepressants, Congress, Melanie Stokes, mothers act, pharmacology, PPD, Pregnancy, suicide, , , , , , , , , , , , ,

Senate Nixes Public Disclosure of Revised Health Care Language: Take Action

As revisions to the Health Care bill have been taking place, the Finance Committee has decided against posting the full text online. Apparently some members of this committee have not even read the final version that they will vote on. Protest the Senate Finance Committee voting on a mysterious health bill that they may not have even read and that they are not allowing the public to read. According to the Finance Committee website, they will get back to work with this Health Care bill again on Tuesday.

Fax this: http://bit.ly/yWbk1 to members of the Finance Committee: http://bit.ly/1b2GX.

Find other Senators on this list http://bit.ly/44KkNP.

Background: See archive of WSJ article here.

Senate Panel Nixes Posting Health Bill Online

WASHINGTON — The Senate Finance Committee opened a second day of debate on health-care legislation, tangling Wednesday over whether the full bill should be made available online before the panel votes on it.

The committee has a “conceptual” version of the health-care bill posted on its Web site, rather than a full legislative text of the bill. Compiling the complex language with amendments into a bill and consequently receiving an official cost estimate would take weeks, according to the committee’s chairman, Sen. Max Baucus.

By a 12-11 vote, the committee defeated a Republican amendment that would have required it to post the full bill at least 72 hours before it votes on whether to approve the measure.

The committee slogged through nearly two hours of debate on the amendment, which was offered by Sen. Jim Bunning (R., Ky.). Republicans argued that the amendment would make the committee’s process on the complicated legislation more transparent.

“It would seem crazy to most people that we vote on something when we didn’t see the legislative language,” Mr. Bunning said. “Well, they’d be right. It is crazy.”

Democrats countered that a conceptual, “plain English” version of the bill does a better job of explaining what the bill would do.

“Let’s be honest about it,” said Sen. John Kerry of Massachusetts. “Legislative language is relatively arcane, very legalistic, and most people don’t read the legislative language.”

Mr. Baucus, a Montana Democrat, warned that the amendment could delay the bill’s passage by two to three weeks, which accounts for time needed for the technical work of adding amendments to the bill. Mr. Baucus also argued that the committee had taken unprecedented steps to provide information on the bill, such as posting proposed amendments to the bill to its Web site two days before the committee took up the measure.

He offered a modified version of the amendment that would require the committee to post the conceptual version of the bill online ahead of a committee vote as well as a preliminary cost estimate from the nonpartisan Congressional Budget Office, but Mr. Bunning said that it wouldn’t provide enough information. Mr. Baucus’s version of the amendment was approved by a party-line 13-10 vote.

Only one Democrat — Sen. Blanche Lincoln of Arkansas — voted for Mr. Bunning’s version of the amendment.


Filed under: Congress, , , , , , , , , , , ,

FDA to Address Online Drug Content

Hey maybe they can go after all the front group drug pushing as well… and the paid consultants and bloggers. Maybe the FDA should go after the New Jersey PPD website. Ya think? My would they have their hands full if they were to try to rope in all the highly compensated / conflicted drug pushers out there…

Wall Street Journal

September 22, 2009, 2:11 PM ET

What Google and Facebook Have to Do With the FDA

FDA InternetIt looks like the FDA is finally moving toward clarifying what’s long been a gray area for drug and device makers: How to deal with the Internet.

At a public hearing in November, the agency will try to hash out tricky subjects like what companies should do about reports of drug side effects appearing online, and how/whether companies should deal with wrong or misleading information that shows up on the Internet. Some companies try to correct information on sites like Wikipedia; others stay out of the fray, for fear of being on the hook for correcting everything once they start wading in.

The hearing will also look at how rules for presenting balanced information apply to online ads and social networking sites. An overview of the hearing was published yesterday in the Federal Register, and it was picked up by the FDA Law Blog and NPR’s Health Blog.

It’s been clear for a while now that the Obama-era FDA isn’t copascetic with the online business as usual. In April, the agency sent warning letters to 14 drug companies over text ads that came up on Google searches and, the agency said, failed to include information about drug risks. Recipients of the letters included big names like Pfizer, Merck and Johnson & Johnson.

And in May, the FDA warned J&J that a video ad for its pain drug Ultram ER didn’t pay enough attention to the risks of the drug. The company told the WSJ it had removed the ad and would respond to the FDA.

http://blogs.wsj.com/health/2009/09/22/what-google-and-facebook-have-to-do-with-the-fda/tab/print/

Filed under: pharmacology

Killing of Pro-Life Activist May Be Related to Psychiatric Drugs

This just in from the moderator of SSRI Stories:

http://www.ssristories.com/show.php?item=3626

Paragraph two reads:  “The man charged with murdering two people in Owosso was battling depression and was experiencing problems with his medication.

Paragraph seven reads:  “Drake is now back in jail after being taken to the hospital over the weekend after a suicide attempt in his cell.”

http://www.wilx.com/news/headlines/59342982.html

Posted: 12:48 PM Sep 15, 2009
Murder Suspect’s Family Speaks

The family of Harlan Drake, the man charged with murdering two people in Owosso, releases a statement about Friday’s killings.


The man charged with murdering two people in Owosso was battling depression and was experiencing problems with his medication.

That’s according to a statement released by Harlan Drake’s family.

His wife, mother and brother also don’t believe the killings were in response to any grudges Drake may have had.

“We do not feel these tragic killings were premeditated, a political statement regarding pro-life or pro-abortion factions, or out of a grudge. We have been overwhelmed by sadness and emotion as we try to understand what happened and why.”

Drake is charged with first-degree murder in the deaths of James Pouillon and Mike Fuoss.

He was arrested at his home shortly after the killings Friday morning.

Investigators say he was also planning on killing a third person.

Drake is now back in jail after being taken to the hospital over the weekend after a suicide attempt in his cell.

A service for Mike Fuoss was held in Owosso Tuesday morning. He was then taken to Chelsea to be buried.

James pouillon was cremated Monday after a private funeral service–however, there will be a public memorial for him at Owosso’s football stadium, at 1pm Wednesday.

That’s Willman Field, on the corner of S. Dewey and Grover street.

Filed under: antidepressants, shootings, violence, , , , , , ,

Remembering Indiana

Tomorrow, September 13, 2009 is the one year anniversary of Indiana Delahunty’s death.

Please go to Christian’s & Matt’s blog to offer some moral support to the family.

http://indibaby.wordpress.com/

Filed under: antidepressants, Baby Matthew, Birth Defects, Christian Delahunty, Christiane Schultz, dead babies, Effexor, Effexor in pregnancy, Indiana, Julie Edgington, Katherine Stone, Melanie Stokes, mothers act, pharmacology, Postpartum Progress, Postpartum Support International, PPD, Pregnancy, Wyeth, ,

What the Media Doesn’t Say about Antidepressants & Pregnancy

In reality, you cannot separate the need for the baby to be healthy and to survive from the mother’s mental state. How many mothers honestly do not worry that something could go wrong with their babies or do not feel responsible for protecting their children? How many women who lost children can go on day by day not feeling anything about that loss? Which antidepressant are you supposed to take to help with depression if you’re dealing with loss after your baby dies from an antidepressant?

Unlike Vogue Magazine or TIME, for some reason ABC has decided to promote more misinformation that will no doubt prove deadly for far too many babies, and possibly mothers too. Read on to find out more…

You may have read a couple of posts I recently wrote (see: here – AMA Review: Antidepressants Pose Significant Risk of Serious Harm to Babies and here – ABC Story on ACOG Release Refers Readers to momsandmeds.com and CHAADA) after I was contacted for a possible story on TV by an ABC producer regarding the ACOG / APA guidelines on antidepressants and pregnancy.

As I wrote in those articles, I had sent numerous emails to the producer with various studies and analyses including not only the conflicts of interest (the conflicts document was so extensive that it took up about 20 pages or so in Word and I didn’t even look up all the names) among the researchers either writing or cited in the report, but also a comparison of the difference between the ABC article they published, and the actual report issued by the ACOG and APA.

I don’t expect that I’ll be hearing much back from them, but the reason I am writing this is not because I really wanted to be on TV (far from it) but because it just makes me horrified that the media can take something that says there is evidence of harm to babies (to quote the ACOG release, “[T]he use of antidepressant medications during pregnancy have been associated with negative consequences for the newborn…some studies have linked fetal malformations, cardiac defects, pulmonary hypertension, and reduced birth weight to antidepressant use during pregnancy.”) and twist it around by quoting “experts” with fancy titles who are willing to say that “the jury is still out” on whether antidepressants can hurt babies. The proposition is that it’s the depression that causes the birth defects, not the drugs.

The ACOG report clearly says that there is evidence of harm – but unfortunately when you watch the videos put out or read the articles on the ABCnews.com website you won’t know that unless you look further.

Just think about cases in which mothers who lose babies to antidepressants or have babies with severe birth defects linked to antidepressants go on to have more children off of antidepressants, without further problems in the babies. Julie Edgington is one example (out of 5 children, only one baby had problems and it was the one exposed to Paxil, Manie, her 4th), Kelly S., who lost her baby to a Paxil heart defect, is another. I was myself told that I shouldn’t have more kids because I would risk severe PPD. I had nothing of the sort. Toby is one of the healthiest kids I’ve seen. I know I am not the best example because I wasn’t actually depressed during pregnancy (was never depressed except for when I was taking Zoloft while nursing), but it just goes to show that there is no conscience regarding the harm coming to babies from these drugs. I was told to stay on Zoloft if I ever did want to have another baby. I am so thankful that Toby is drug-free and healthy.

I honestly do not know how these people can live with themselves.

A great example of what the public sees if they are not up on the latest information, but just passively receiving news bytes, is the ABC piece that just came out which covers Heather Armstrong’s story and states that there is no convincing proof that antidepressants cause harm to the baby. In it Heather tells ABC that she went off her meds during her last pregnancy but experienced panic attacks, and then later, suicidal thoughts after her baby was born, so she decided to stay on it during this recent pregnancy.

1) Of course when you go off antidepressants you can experience panic attacks or even suicidal thoughts – it’s called withdrawal. Been there, done that. For me the withdrawal was way worse than being on the drug at a stable dose, but once I got off of the drug and had time for it to clear out of my system I felt so much better.

Even if you were suicidally depressed before ever taking antidepressants, that does not mean that antidepressants will cure the suicidal thoughts, nor does it mean that you cannot find safe and effective alternatives (link to postpartum nutrition / orthomolecular medicine article). (See also: Preventing & Treating Emotional Problems and a post about counseling and self help.)

Perhaps Prozac really helped Heather feel better mentally but that does not justify what could have happened to the baby. During her last pregnancy she says that she had panic attacks. I think I’ll take panic attacks over my baby dying. It wasn’t even until after her baby was born that she says she had suicidal thoughts. So, were those a result of a drug withdrawal, or did she have a hormonal imbalance after birth of estrogen or thyroid that so many women have? I can’t claim to know what caused Heather Armstrong’s depression after her birth of her first child, but I can guarantee that it was not a Prozac deficiency and that there are safe treatments available. However it still makes no sense to me why having PPD would lead someone to consciously decide to take drugs during a subsequent pregnancy. If you had PPD before, then by all means if you are going to take drugs for PPD, do so after the baby is born and don’t do it while nursing. The time it takes you to get your placebo effect should be well worth it considering the peace of mind and increased safety for the baby.

In my opinion the reason women do this sort of thing stems from the misinformation fed to them by their doctors or other people in the public doing the off label marketing spin. Off-label marketing, or promoting psychiatric drugs to pregnant women (no psychiatric drug is FDA approved for pregnancy), by the way, is currently illegal, but the drug companies usually find ways to get others to do it for them. That’s more than I can say for Pfizer’s criminal behavior with the illegal marketing of Geodon and Lyrica.

2) Just because Heather Armstrong’s baby was born without complications (and she had an unmedicated birth if I am not mistaken) does not mean that the drugs are safe. Nor does it mean that whatever drug she is feeding her daughter in her breast milk is safe for the baby. I am so thankful that her daughter is ok so far, because no baby deserves to suffer from these drugs and I truly hope that she continues to be ok.

But this does not excuse pushing drugs on the entire country with misleading information from conflicted “researchers.”

Here is what you will probably not see on ABC any time soon:

(I hope ABC will prove me wrong, but so far no such luck)

Craniosynostosis caused by Antidepressant Exposure

Craniosynostosis before / after surgery (caused by antidepressant exposure)

Omphalocele caused by antidepressant exposure

Omphalocele caused by antidepressant exposure

Anencephaly (lack of forebrain) caused by antidepressant exposure - 100% fatal

Anencephaly (lack of forebrain) caused by antidepressant exposure - 100% fatal

Look at these devastating photos and ask yourself if it is really worth it to expose your baby to something that can cause a birth defect like this, when there is no taking back the exposure. I lived through suicidal and homicidal thoughts for four months because of Zoloft and I would not want to live through that again, but I would rather go through it (drug-induced or not) a hundred more times rather than have to live through losing a baby or having a baby born with a severe birth defect.

Everyone is bound to go through sad times, depression, grief and despair at some point in their lives but that does not mean that the entire human population suffers from serotonin deficiencies (when in reality serotonin excess is what leads to problems in the first place) or “chemical imbalances.”

I enjoy occasionally drinking wine or mixed drinks, but that doesn’t mean that because I feel relaxed while drinking alcohol, that I should drink when pregnant or that I suffer from an alcohol imbalance.

Women deserve to know the truth about what can happen with these drugs. They deserve to get the truth about what is causing their emotional problems (not some sales tactic like attributing it to an unproven, unprovable chemical imbalance) and how to safely deal with them with “alternative” medicine, orthomolecular medicine, proven hormone therapy, counseling, etc. They deserve support and understanding and compassion. They do not deserve to be fed deadly lies. But mostly, their babies deserve for the mothers to know.

ABC quotes doctors who say you cannot separate the health of the child from the health of the pregnant mother. This is an illogical catch phrase that they use in order to try and make us feel guilty for insisting on drug free options because some women obviously already take antidepressants and find it impossible to stop (again, this is caused by horrific withdrawal and the drug companies seem fine with that). Try and think about what this really means. They are saying that the mother’s mental health cannot be ignored during pregnancy because doing so hurts the baby. They are saying depression is more dangerous than drugs to the baby. Aside from the fact that this is clearly untrue, and that antidepressants do not reduce birth defects, but rather, increase them, think about whether you have ever been sad during pregnancy. Does feeling sad during pregnancy or being depressed cause PPHN, cardiac defects, the lack of a forebrain, and stillbirth? Or do toxic drugs with mystery chemicals that dangerously elevate serotonin and affect the organ development of babies cause these problems?

Something most people don’t know is that Fen-phen which was taken off the market for heart and lung-related deaths is actually a serotonergic drug which was a chemical mirror image of an SSRI. As I have said repeatedly and will say again, when you have drugs leading to heart problems and PPH in adults, how could they possibly not hurt babies the same way or worse?

Even after considering the fact that antidepressants actually cause depression and suicide, and work about as well as a placebo, this catch phrase makes about as much sense to me as saying that a mom who is addicted to crack, or drinks 5 coffees a day, or smokes, or is an alcoholic, should be told to keep doing those things if it eases her anxiety or fatigue while pregnant. Or about as much sense as telling women to go take Thalidomide because we’re not really sure that Thalidomide causes problems and it was probably actually the morning sickness causing the birth defects and not the Thalidomide. The jury is still out on whether swallowing RAID or drinking bleach while pregnant is bad for your baby. Perhaps working in a nuclear plant or handling plutonium should be considered safe for pregnant women too.

In reality, you cannot separate the need for the baby to be healthy and to survive from the mother’s mental state. How many mothers honestly do not worry that something could go wrong with their babies or do not feel responsible for protecting their children? How many women who lost children can go on day by day not feeling anything about that loss? Which antidepressant are you supposed to take to help with depression if you’re dealing with loss after your baby dies from an antidepressant?

Stop lying to women about what are confirmed, known risks.

If the jury were still out, the FDA would not be issuing warnings like:

“Infants born to mothers who took SSRIs after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”

See: PPHN Paxil baby Sarah Hart here. Sarah survived, but Matthew did not.
Face to Face:
http://www.flickr.com/groups/madnapfacetoface/

See more FDA MedWatch Data here: http://www.cchrint.org/psychdrugdangers/MothersAct.html

I can only hope that every person responsible for off-label marketing will be held accountable in some way. I am no expert in FDA  or criminal law, but when you essentially have money laundering taking place – drug companies giving donations to organizations, who then promote drugs through their own organizations via blogs, press releases, and speeches, it would seem that either the drug companies, or the individuals doing the marketing should be held to account for the off label promotions.


Warnings/Studies Showing Risks Associated with Antidepressants and Pregnant Women or New Mothers:

There is ample evidence to support the risks associated with placing pregnant women or new mothers on antidepressant drugs:

  • September 7, 2005: The Australian Therapeutic Goods Administration issued an information sheet to health professionals warning that SSRI antidepressant use—especially Paxil—in early pregnancy could cause congenital [defect at birth] heart abnormalities in newborns.[i]
  • September 27, 2005: The FDA and GlaxoSmithKline issued a warning that pregnant women taking Paxil or other antidepressants during their first trimester of pregnancy, placed their newborns at increased risk of major congenital and cardiovascular [heart] malformations at birth.[ii]
  • February 9, 2006: The New England Journal of Medicine found that mothers who took SSRI antidepressants 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 would die even if they receive treatment.[iii]
  • March 10, 2006: Based on the New England Journal of Medicine study, Health Canada issued a warning that SSRI antidepressants and other newer antidepressants when taken by pregnant women placed newborns at risk of developing the rare lung condition; persistent pulmonary hypertension or PPHN.[iv]
  • April 7, 2006: A Canadian study from the University of Ottawa published by the American Journal of Obstetrics and Gynecology, found pregnant women who used SSRI antidepressants were more likely to have premature and low birth weight babies.[v]
  • June 2006: An Archives of General Psychiatry study found women who take antidepressants during pregnancy at risk of giving birth to children with respiratory problems.[vi]
  • July 19, 2006: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took SSRIs during pregnancy. The agency added it was seeking more information about persistent pulmonary hypertension in newborns from the drugs. It asked drug makers to list the potential risk on their drug labels.[vii]
  • November 2006: The journal Epidemiology published a study entitled “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations.” Researchers did the study from Aarhus University. It found that pregnant women who take SSRI antidepressants are more likely to have babies with birth defects than mothers who don’t take these drugs.[viii]
  • August 2007: The American Journal of Psychiatry published a study that determined that antidepressant use during pregnancy was associated with premature births.[ix]
  • September 18, 2007: A study published in the Annals of Internal Medicine of nearly 500,000 women by researchers at the University of Pittsburgh Medical Center found that nearly 50% of women taking a prescription drug that could cause birth defects did not receive warnings to avoid pregnancy.
  • Moreover, experts say the seriousness of a life-threatening lung disorder found six times more often in infants born to mothers who take antidepressants during pregnancy is not being adequately conveyed to women while they are considering whether to use the drugs.[x]
  • The Physicians’ Desk Reference (PDR) states: “Like many other drugs, paroxetine [chemical name for the antidepressant Paxil] is secreted in human milk, and caution should be exercised when Paxil…is administered to a nursing woman.”

Selected SSRI Antidepressant Studies/Warnings on Suicide Since 2001:

  • March 22, 2004: The FDA warned that SSRIs could cause “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness], hypomania [abnormal excitement] and mania [psychosis characterized by exalted feelings, delusions of grandeur].”
  • February 18, 2005: A study conducted at the Ottawa Health Research Institute and published in the British Medical Journal determined that adults taking SSRI antidepressants were more than twice as likely to attempt suicide as patients given placebo.[xi]
  • June 30, 2005: The FDA issued a Public Health Advisory entitled “Suicidality in Adults Being Treated with Antidepressant Medications,” that there could be an increased risk of suicidal behavior in adults taking antidepressants. It recommended that physicians monitor adults who took antidepressants for suicidal tendencies.[xii]
  • August 4, 2005: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin reporting evidence supporting an association between SSRI use and “new onset of suicidality” in adults.[xiii]

[i] “Information for health professionals concerning the use of SSRI antidepressants in pregnant women,” Australian Therapeutic Goods Administration,” 7 Sept. 2005.[ii] “Important Prescribing Information,” Letter to healthcare professionals by GlaxoSmithKline, Sept. 2005; Miranda Hitti, “New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants,” WebMD Medical News, 27 Sept. 2005.[iii] 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., “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn,” New England Journal of Medicine, Vol. 354, 2006, pp. 579-587.

 

[iv] Health Canada Advisory, “Newer antidepressants linked to serious lung disorder in newborns,” 10 Mar. 2006.

[v] Andre Pickard, “Prozac-type drugs increase birth risks, study finds,” Globe and Mail, 4 June 2006.

[vi] Tim F. Oberlander, M.D., FRCPC; William Warburton, Ph.D.; Shaila Misri, M.D., FRCPC; Jaafar Aghajanian, B.Sc.; Clyde Hertzman, M.Sc., M.D., FRCPC, “Neonatal Outcomes After Prenatal Exposure to Selective Serotonin Reuptake Inhibitor Antidepressants and Maternal Depression Using Population-Based Linked Health Data, Archives of General Psychiatry, Vol. 63, 2006, pp. 898-906.

[vii] “Antidepressants should list new risks: FDA,” Reuters, 19 July 2006.

[viii] Wogelius, Pia, Nørgaard, Mette, Gislum, Mette, Pedersen, Lars, Munk, Estrid, et.al. “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations,” Epidemiology, Vol. 17, No. 6, Nov. 2006.

[ix] Rita Suri, M.D., Lori Altshuler, M.D., Gerhard Hellemann, Ph.D., Vivien K. Burt, M.D., Ph.D., Ana Aquino, B.S., Jim Mintz, Ph.D., “Effects of Antenatal Depression and Antidepressant Treatment on Gestational Age at Birth and Risk of Preterm Birth,” American Journal of Psychiatry, Vol. 164, Aug. 2007, pp. 1206-1213.

[x] Evelyn Pringle, “Women not warned about SSRI-related lung birth defect,” Countercurrents.org, 2 October 2007.

[xi] “Drugs Raise Risk of Suicide; Analysis of Data Adds to Concerns on Antidepressants,” The Washington Post, 18 Feb. 2005.

[xii] “Suicidality in Adults Being Treated with Antidepressant Medications,” FDA Public Health Advisory, 30 June 2004.

[xiii] “Suicidality with SSRIs: adults and children,” The Australian Therapeutic Goods Administration (TGA) Adverse Drug Reactions Bulletin, Vol 24, No. 4, Aug. 2005, p. 14.

Filed under: antidepressants, Baby Matthew, Birth Defects, child endangerment, Christian Delahunty, Christiane Schultz, dead babies, Effexor, Effexor in pregnancy, FDA Warnings, Indiana, Informed Consent, Isaac Philo, Julie Edgington, Paxil in pregnancy, PPD, Pregnancy, toxicity deaths, Withdrawal, Wyeth, Zoloft, , , ,

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UNITE News

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Protect babies from drugs

Eli Lilly Funds Depression Screening Initiatives

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Matthew Schultz killed by Effexor. Two hours old.

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Big Pharma Victim

  • I haven't been on in awhile thanks to all those who followed 3 years ago
  • @LindsayRush yay IOWA! 4 years ago
  • Another rainy day here in IOWA. Well at least i had a good time swimmin yesterday. 4 years ago
  • Hey everyone hope you have a great day! THanks to all the new followers :) and for those that continue to follow 4 years ago
  • srry if I dont get on here much I mostly just look at my facebook acct. thanks to all the new followers! 4 years ago

The Indiana Star

Christiane Schultz

  • Is not coping well at all. Loss sucks! 4 years ago
  • is scared to bond with this baby, just in case. 4 years ago
  • Happy 6 months today baby. I love you Matthew. 4 years ago
  • Living with loss, sucks. 4 years ago
  • Thinking I need to discuss plans for this baby soon or I will be having it in my doctors office. Where do I deliver? 5 years ago

Amery Schultz

Seeking Parents in Missouri for Celexa / Lexapro Class Action – Call 800-827-0087

TWEET FOR LIFE

BREATH – The Official Blog of MADNAP – momsandmeds.com

RSS BREATH

  • Untitled
    Originally posted on The Bitter Pill:Kickstarter is a website for artists to use to raise money and complete awesome projects. The best thing to come to the informed consent movement since Thomas Szasz could just be the new, upcoming film by Dan Jenski, “ADDicted” which basically gives Ritalin, Adderall, Concerta and the like a…
  • Untitled
    Originally posted on The Bitter Pill:In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman…
  • Antidepressants Again Linked to Preterm Birth & Seizures
    In what was more than likely originally an attempt to prove that depression causes birth complications, researchers from Yale, Tufts, et al found in two new studies that antidepressants increase the risk of preterm birth and seizures. Read more at this link on the newly redesigned UNITE website.
  • Who Could Do This On Purpose
    Read this blog to find out
  • Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed
    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

UNITE ARCHIVES – Victims & Survivors Against The MOTHERS Act: YouTube Playlist

Videos: Psych Drugs, Birth Defects, Infant Death, Violence & Suicide

UNITE ARCHIVES – Add Your Group To The Coalition Against The MOTHERS Act

CADIMA: 54 Groups and Counting!

UNITE ARCHIVES – The MOTHERS Act Citizen Voting Area on Open Congress

Status: 76% AGAINST S. 324 The MOTHERS Act. Vote & Comment.

UNITE ARCHIVES – Join the Coalition Against The MOTHERS Act on Facebook!

3,271 Facebook Members and Counting!

UNITE ARCHIVES – Stop The Dangerous and Invasive MOTHERS Act!

13,500 Signatures and Counting!

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