The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

HeART Auction Update 1: eBay Link

The HeART Auction has been launched! It is now up and running here: http://myworld.ebay.com/iowajulz/
To donate items to this auction please email give2manie@yahoo.com.

Filed under: antidepressants, antidepressants during pregnancy, artist, artwork, baby, bigpharmavictim, Birth Defects, birth defects caused by antidepressant, birth defects lawsuits, heart defects, Julie Edgington, Manie, Manie Life stories, manie's dad, Paxil birth defects trial, Paxil in pregnancy, paxil manie, Pregnancy, works of art, , , , , ,

HeART Auction: Art Auction for Paxil Heart Defect Victims

UPDATE – AUCTION HERE: http://myworld.ebay.com/iowajulz/

Attention Art Lovers!

You may know the story of Manie, the baby born with Transposition of the Great Arteries (video link – see also: footage of Manie crying after his air tube was removed – mom unable to hold him as a newborn -  http://www.youtube.com/watch?v=OHuCMcnihj8). The family has a case pending against GSK for Manie’s heart defect caused by Paxil, a case which is not moving quickly… and medical travel expenses for Manie are hitting the family hard.

Currently dad Russell is looking for work and Julie is unable to work due to caring for Manie and her other kids. The family is now auctioning off some of their artwork. Check back for updates and additional photos, paintings, and other artwork being submitted for auction.

Ten percent of the sales will be donated back to the UNITE / MADNAP cause for public awareness to help save other babies. For more information on how we utilize donations send an email to amy@uniteforlife.org.

To donate commissioned artwork or other goods to this auction, contact Julie & Russell at give2manie@yahoo.com.

We welcome artwork by children or adults, professional or not. Any other items you would like to donate to the family for an auction, as well as direct monetary donations, are appreciated. The auction will most likely run on eBay through December 25.

Here are some samples of the amazing artwork by Julie & Russell (stay tuned for updates):

Who’s America

http://wp.me/phViU-vK

Tattoo

http://wp.me/shViU-tattoo

My Nightmare by Julie

Heart of Gold by Russell and Julie

http://wp.me/phViU-vH

Filed under: antidepressants, bigpharmavictim, birth defects caused by antidepressant, birth defects lawsuits, brave kids, Julie, Julie Edgington, life stories, Manie, Manie Life stories, manie's dad, Manie's Family, Manie's parents, Pregnancy, , , , , , , , ,

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, , , ,

1031 Deaths of Babies Exposed to Psychotropic Drugs

“There’s no tragedy in life like the death of a child. Things never get back to the way they were.”
- President Dwight David Eisenhower

Below is a link that shows some of the MedWatch reports submitted to the FDA of deaths caused to babies by exposure prenatally and neonatally to psychotropic drugs. This does not include the birth defects and withdrawal syndromes for babies who did survive exposure, which seems to be the only thing we usually hear about in the media concerning the drugs’ risks for babies. These figures are based on about a four year time period and represent from 1-10% of likely actual deaths. Keep in mind that these were preventable deaths of helpless babies which would not have occurred were it not for the exposure to psychotropic drugs prenatally and neonatally.

Go to http://psychdrugdangers.com/MothersAct.html and look through the summary tables for the 1,031 Abortions, Miscarriages & Other Deaths. You can see the breakdown for each drug class.

Filed under: "mood stabilizers", "prevention", Effexor, Effexor in pregnancy, experimentation, forced 'treatment', Fred Baughman MD, Indiana, Informed Consent, Isaac Philo, Julie Edgington, Katherine Stone, lawsuits, Melanie Stokes, mothers act, , , , , , , , , , , , ,

Julie Edgington Responds to Karen Kleiman

Here is my comment to Mothers act scooped again. I doubt if she will post it.

My name is Julie Edgington. My son Manie was born with a rare heart defect because I took Paxil during pregnancy. I am the creator of www.bigpharmavictim.blogspot.com

Your post and your site upset me greatly. I am shocked you would use a blog, which is supposed to help women with PPD, to voice your own personal opinion. You are clearly the one who is misinformed. How dare you be a big pharma rep and act as if you want to help women with PPD. By reading some of the stuff on your site I know who and what you really are. The way you describe PPD in your blog it sounds like you got it right out of an ad for an SSRI.  Way to use your years and years of training to help push pills.

If you cared at all for the women why would you stick up for the Mothers Act? Have you read it? Or are you just going by what is in the name and because the name sounds good it must be good. OR you have read it and thought if women have to be screened for PPD then that would mean more clients for you and for your book sales. Hmmmmm that is a thought now isn’t it.

I could talk all day but you probably will not listen because you were taught not to by big pharma. Why am I really mad about your post… I am mad because I have spent 2 years telling Manie’s Story just so people like you who use a false sense of compassion to get women to take more drugs. These drugs, which are no better then a placebo, to deal with the sadness you are telling them they have. Oh yeah lets not forget your added benefit of the extra book sales!

I tell Manie’s Story because big pharma is still pushing SSRIs on women of childbearing years knowing what could happen to their babies. Someone has to show people what the risk looks like. You may have heard this before “If the benefits out weigh the risk” There are no benefits to these drugs. They are quick to tell women how they are feeling and it is wrong to feel that way.

They want to put labels on these emotions so they can tell you how to treat it with their pills. Their quick fix in a bottle does nothing but make it worse and not just ruin one life, it ruins the lives of everyone around you. Ask Manie if the benefits out weighed the risk.

If it was your body and your unborn baby would you want someone telling you you HAVE to take something to feel better?

Post or don’t post this comment on your blog. I am sure you won’t. Like many others who want to act like they know everything you wouldn’t want to post something which would make people think for a second about what is really going on.

Julie

Filed under: antidepressants, Birth Defects, Julie Edgington, Manie, mothers act, PPD, Pregnancy, profit, ,

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