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 any comments you may have to amy@uniteforlife.org by Thursday of this week (November 10, 2011), or call 817-793-8028.

See the following note from Amery:

I am looking for input as to what you feel should be included in recommendations for establishing protocols surrounding women being treated with and babies exposed to psychotropic medications during pregnancy. These recommendations will be presented to both the Canadian Pediatric Association as well as the Society of Obstetricians and Gynecologists of Canada. We have found a good ally who is proposing that we address the National Conference of the Canadian Pediatric Association.

• My Bad – Mothering Magazine Promotes “Antipsychotics” Not Just Zyprexa
• Mothering Magazine Publishes Letter Reaming Them for Being So “Anti-drug”
• Open Letter to the Editor of Mothering Magazine – Re: “Beat The Baby Blues” by John Breeding and Amy Philo
• Relentless and Tragic Marketing: Psychiatric Drugs from Before the Cradle to the Grave

We will be at the Addison Wellness Expo this weekend, October 16-17 with an educational booth for UNITE, MADNAP and The Indiana Star Foundation. We are conducting a fundraiser to defray the costs of participating in this event and conducting other awareness activities.

Several wonderful and generous donors have contributed. We are raffling off a free photography session with Natasha Hance. Tickets are $5. If you want to purchase online, you can use the donate button on this website to pay via our pledgie account and then send me an email to let me know how many tickets you bought.

We will be selling “Quilts for A Cause,” and various items such as hand-knit baby and children’s winter hats, bracelets, hand-made jewelry and other fun items.

My friend and fellow activist Ellen Liversidge (who lost her son Rob to Zyprexa-induced hyperglycemia) has generously allowed me to confiscate over two dozen of her vintage quilts to sell. She runs a business selling them, so we will be accepting all small to extravagant offers above cost for the sale of these quilts! I’ve set up a Flickr account and blog to showcase the quilts. Minimum prices on the quilts will be posted soon. If you see one that you want please email me at amy@uniteforlife.org so we can get it shipped to you.

Many thanks to the following donors:

Peek Aren’t You Curious at Northpark Mall (gift bags)

Jenny M Jewels (hand-made earrings)

Christian Delahunty (baby quilts, hand-made jewelry and more)

Amery & Christiane Schultz (MADNAP Teddy Bears)

We are also going to be handing out pink and blue ribbons in honor of October – Infant Loss Awareness Month.

http://pledgie.com/campaigns/6067.

To enter, just use PayPal (through PayPal you can use your bank account or a credit card) on our Pledgie page, and then email amy@uniteforlife.org with your contact information and # of raffle tickets you bought, so we can send you the gift code if you win!!!

• Happy First Birthday my little man!
• To Matthew on your 1st Birthday
• Hi Son
• “February Twenty-First”
• Disgusted.

Then, please take action to spread the word by going here.

There are also several new articles on The Bitter Pill related to antidepressants during pregnancy. Check them out:

• Taking Antidepressants During Pregnancy Doubles Baby’s Risk of Heart Defect
• Paxil Birth Defect Trial – Battle of the Experts by Evelyn Pringle
• Evelyn Pringle: Paxil Birth Defect Litigation – First Trial A Bust For Glaxo
• SIDS, Serotonin and Subscriptions: Update

Here is her reply:

In my new book, Drug Induced Dementia – A Perfect Crime, (Amazon link) one of the points I tried to make in Appendix B is that most doctors have not been trained to appreciate that there are probably at least three discrete phases of drug withdrawal.

a) Acute withdrawal period

- How long it takes the drug to clear the bloodstream – and how long it takes the drug to clear the BRAIN TISSUE itself

In some cases, the elimination time for the blood vs. the brain tissue is NOT equal. This is known as “dissociation” but most doctors know nothing about this fact…

Also, we do not have good data on all drugs… Usually, this comes from research experiments using MRS [magnetic resonance spectroscopy] and fluorinated molecules.

b) Intermediate withdrawal period

- This refers to the length of time it takes for receptor physiology and receptor > 2nd messenger/3rd messenger events to “re-equilibrate.”

c) Long term withdrawal period

- This refers to the length of time it takes for GENE EXPRESSION to return to pre-drug status; and for protein expression >>> “cell-cell” communication and wiring to change.

When you are talking about miscarriages, rather than PPHN, all bets are off.

The reason for this is that UNLIKE sperm, which are made, secreted, and replaced for many decades, ALL of a woman’s eggs are present at BIRTH.

That means all of a woman’s eggs are being exposed to all chemicals throughout the mother’s lifespan, even before pregnancy… As I have written and lectured about in the past, all of the psychiatric drugs – with the exception of the stimulants so far, are being studied as adjuvant [add on] treatments for various cancers. The reasons why these drugs are effective in slowing tumor growth [etc.] is because they interrupt cell division and/or cell growth.

So, if you reason this through, it is extremely risky to expose any developing fetus to chemotherapy [thalidomide, for example, is now used as a chemotherapy for myeloma]. If any mother had been taking Effexor for years prior to conceiving, I know of no way to protect the new fetus from potential birth defects arising from the years of egg exposure to the Effexor during the past.

Unfortuately, I know of no one who is studying this question in any seriousness, because it is a question that is not generally posed.

I would suggest that it would be unlikely to find Effexor in the blood or brain 3 months after stopping Effexor, but this would not necessarily mean that 8 years of Effexor usage in the past would not still be capable of producing lasting effects.

We do not know how long term [or even short term] might be damaging eggs.

We also do not know how long term exposure to Effexor in the past might exert a lasting detrimental effect upon the mother’s ability to make serotonin. The fetus depends upon the mother for all of its serotonin for the first weeks of gestation [sorry, I do not recall from memory the exact week of development at which the fetus starts to make its own serotonin in the gut -- I shall have to look this up for you or you should consult an embryologist].

Since long term users of antidepressants appear to develop a long-term vulnerability in the capacity to tolerate DECREASES in serotonin — which may involve their own increasing inabilty to make adequate serotonin, it stands to reason that chronic users of antidepressants place their fetuses at risk for a serotonin deficiency in the 1st trimester (etc.).

Why is this critical? Serotonin is an essential growth hormone for the fetus.

Grace

Question: I thought psychiatric drugs were also carcinogens – am I wrong on this? If I am right, are they both carcinogens AND tumor treatments?

But of course !!!!

This is a complicated phenomenon that, I guess, the public seldom (?never?) hears about.

All chemotherapies that “fight” cancers are also interventions that can “cause” cancer.

I’m not sure that anyone has made a good study of the exact prevalence of this phenomenon, but the classic case in point arises with a category of chemotherapies known as alkylating agents…

I quote from one of the most useful pharmacology textbooks which I own [Lippincott's Illustrated Reviews - Pharmacology, 4th Edition Editors: Harvey and Champe] “Because most antineoplastic agents are mutagens, neoplasms [for example: acute nonlymphocytic leukemia] may arise 10 or more years after the original cancer was cured.”

This raises interesting questions about the long-term effects of many psychiatric medications — from everything that i have read and researched to date, it would seem that most consumers of neuroleptics and anticonvulsant drugs are dropping dead in their 50s and 60s PRIOR to the emergence of cancers… however, if we really think about what has happened since the epidemic spread of Prozac and other alleged “anti”-depressants since the 1990s, we do not yet have good long-term data on the possible emergence of a leukemia [or other] cancer epidemic that still might appear down the line…

Grace

I was wondering about umbilical cord abnormalities and antidepressants so I decided to do a google search and couldn’t find much aside from unrelated drug selling websites that used every key word imaginable.

So, I pulled a few reports (not all the reports, just a sampling) from the decrypted MedWatch report database on the topics of intrauterine death and umbilical cord abnormalities (Thank you CCHR!).

Some also have placenta problems although I did not do a search on those specifically. The decrypted MedWatch data seems to be one of the only sources for finding this information on what is really associated with antidepressant use / psych drug use. I think it is really one of the best sites on the internet because you can search for a specific side effect and see how many reports there were. The main psychdrugdangers database even breaks it down for you by age range.  The MOTHERS Act / prenatal / neonatal database section has all the reports you need to see if you are looking for pregnancy and breastfeeding reports since 2004.

I love this site because you are able to see the truth and not have to wonder about any conflicts of interest with the researchers, agendas, or bad motives like you would if you only read the complete b.s. being offered up by websites of moms on drugs, psychs in the pocket of pHARMa, etc.

Because of the seriousness of this issue I feel that every mom should have access to this information so I hope you will share this with your friends, you never know who it may help to save. (See: October 15 Infant and Child Death Awareness and Prevention Day).

On that note, I highly recommend the book Wise Woman Herbal for the Childbearing Year by Susan Weed. It talks about herbs and vitamins that can be used to help prevent miscarriage, to stop miscarriages in progress, promote uterine health, and what herbs and foods to avoid to protect your baby during pregnancy.

I have this book on my shelf, and I looked up some information for a friend once… Using some of the recommended vitamins during a time when she was having bleeding and on bed rest during the second trimester, things improved. Another great product she used is called Carry On which is for bleeding and prevention of miscarriage. Every time I see her baby I think about those products and how they possibly saved that baby’s life. We found out about that product from a friend on a home birth listserv.

If you’re not on any mommy listservs or yahoo groups I recommend trying to find a holistic one to get advice from holistic friends like this. The MADNAP listserv, UNITE listserv, and CHAADA listserv are all hosted on Yahoo and would be a good place to start. We have several home birthing moms on there who have experience with alternative health and can refer you to other resources / groups.

Now for the sample reports I pulled: If you have had a similar incident while taking a psychiatric drug or shortly after withdrawing from one, please consider making a MedWatch report by going here:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

http://www.thefetus.net/page.php?id=167 According to this article on velamentous insertion of the umbilical cord, the anomaly is associated with congenital abnormalities and preterm birth. These are problems commonly associated with antidepressants. One study found a nearly five times higher rate of preterm birth for babies exposed to antidepressants. [“Infants exposed to fluoxetine during the third trimester had, compared to those exposed only during the first and second trimester, reduced birth weight and length, an almost 5-fold increased risk of premature delivery, a 2.6-fold increased risk of being admitted to special-care nurseries, and an almost 9-fold increased risk of experiencing respiratory difficulties, cyanosis on feeding, and jitteriness.” Birth outcomes in pregnant women taking fluoxetine. Chambers CD, et al. N Engl J Med, 335(14):1010-5 1996 Oct 3.]

DECRYPTED REPORTS:
http://www.cchrint.org/psychdrugdangers/MothersAct.html

EFFEXOR

M 6026440 4964817 03/01/2006 04/03/2006 Venlafaxine Depression Caesarean Section, Drug Exposure During Pregnancy, Testicular Torsion, Umbilical Cord Abnormality

M 6232679 5232270 07/01/2006 02/07/2007 11/01/2006 Effexor XR CN Anomaly of External Ear Congenital, Intra-Uterine Death, Limb Malformation, Low Set Ears, Skull Malformation, Transmission of Drug Via Semen, Umbilical Cord Abnormality

6040906 4985077 09/07/2005 04/19/2006 Effexor XR Pyramidal Tract Syndrome Brain Malformation, Cerebral Cyst, Drug Exposure During Pregnancy, Exomphalos, Intra-Uterine Death, Talipes

5827164 4692986 06/15/2005 Effexor XR OT Drug Exposure During Pregnancy, Intra-Uterine Death

F 5941024 4845757 11/30/2005 Effexor XR Depression Abortion Spontaneous, Depression, Disease Recurrence, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Foetal Growth Retardation, Intra-Uterine Death

PAXIL

F 5892354 4789790 10/06/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Intra-Uterine Death, Placental Disorder, Umbilical Cord Abnormality, Umbilical Cord Vascular Disorder

M 5991062 5464256 11/02/2005 09/21/2007 Paxil CR CN Maternal Condition Affecting Foetus Arrhythmia, Atelectasis, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Caesarean Section, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Complex Partial Seizures, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oedema, Oral Intake Reduced, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pleural Effusion, Post Procedural Complication, Postoperative Thrombosis, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Speech Disorder Developmental, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Umbilical Cord Around Neck, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux (This one was accidentally copied and pasted, and I just realized doesn’t have umbilcal cord abnormalities, just around the neck, but it was such an awful case I felt I should keep it in.)

F 5654406 4488092 03/23/2004 10/28/2004 Paroxetine MD Depression Cytomegalovirus Infection, Drug Exposure During Pregnancy, Intra-Uterine Death

5819180 4690656 02/24/2005 06/15/2005 02/24/2005 Deroxat CN Drug Exposure During Pregnancy, Intra-Uterine Death

WELLBUTRIN

F 5701388 4536190 09/17/2004 12/23/2004 Bupropion OT Depression Chorioamnionitis, Drug Exposure During Pregnancy, Intra-Uterine Death, Micrognathia, Umbilical Cord Abnormality

26 Years F 6000982 4938300 03/09/2006 Bupropion OT Depression Drug Exposure During Pregnancy, Hypertension, Umbilical Cord Vascular Disorder

M 4011323 4279456 01/27/2004 Wellbutrin MD Depression Abdominal Wall Anomaly, Arteriopathic Disease, Chorioamnionitis, Cleft Palate, Congenital Atrial Septal Defect, Drug Exposure During Pregnancy, Ear Malformation, Intra-Uterine Death, Jaw Fracture, Kyphosis, Liver Disorder, Lymphangiectasia, Macrognathia, Nose Deformity, Pectus Excavatum, Placental Disorder, Spleen Malformation, Thyroid Disorder, Traumatic Delivery

F 6172347 5156305 11/22/2006 Wellbutrin OT Drug Use for Unknown Indication Drug Exposure During Pregnancy, Intra-Uterine Death

There are also several updates on her blog regarding the current Paxil birth defects trial being covered by Bloomberg news.

Reoccurring Nightmare

by Julie Edgington

Last night I had a reoccurring nightmare which I have had since I found out it was Paxil which caused Manie’s birth defect. Usually I wake only remembering bits and pieces of my nightmare, but not this time. This time I woke with tears streaming down my face and a tear soaked pillow.

My Nightmare:

I saw myself standing there in the kitchen of our old house. This was the house I had been living in when I became pregnant with Manie. I knew right away exactly what moment from the past this was. It was so clear this time as if I was really there watching it all happen. Not only was I watching this happen I could physically feel everything that I felt that day. I watch and felt myself push the kitchen chair in that someone had left pulled out. I watch and felt myself get a glass of water. I even felt the coldness of the glass in my hand. I knew what was going to happen next because I had already done this.

At this time I felt someone holding my hand I looked down and it was Manie. He looked up at me and the sadness on his face let me know he knew what was about to happen too. As I looked at him I could hear his heart beating. I knew it was his because of the sound of it. His heart sounds different then any other heart because of the leak. As I continued to look at him I could hear my own heartbeat also. It was as if I could hear his heartbeat in my right ear and mine in the left, both beating at the exact same time. As I stood there looking at him my chest began to ache. With every heartbeat mine was changing to sound just like Manie’s. I felt as if I had ran a marathon and had a heart attack all at the same time. Before I knew it the two heartbeats were now one. I felt scared and worried, but not for me for Manie.

I began to look around for something to help us. I remembered where we were and at what time. I realized I can stop this! As I looked straight ahead of me I saw myself taking the pill from the package. I screamed and I tried to move, but there was nothing I could do! I could not hear myself. My feet were locked to the floor. The more I watch the more I felt our heart pounding and the louder it became. I looked down at Manie and he just stand there crying as if he knew I could do nothing. I continued to scream but nothing worked. Then I could feel it, the feeling of that damn pill in my mouth and the drink of water that carried it down. I felt it as if it was really happening. In a last ditch effort to make it all better I closed my eyes and slowly instead of having just one heartbeat there was two again. The heartbeat in my right ear was normal and healthy. I gave Manie my heartbeat and I took his. As much as my heart ached with pain and as tired as I was I felt good inside. I could feel the scars on my chest. I looked at Manie’s chest his scars were gone. Manie smiled at me and let go of my hand. I could not hear our hearts beating anymore, but I knew he would be alright.

Manie and I were no longer in that old kitchen, we were outside. I watched as Manie ran and ran and ran. I watched as he played football, basketball, baseball and hockey. I watched as he rode the scariest of amusement park rides. There was no more waiting in doctors offices, no more hospitals, no more leg and arm cramps and no more waking in the middle of the night in pain. There was no more medications. Manie did not look tired because he was not tired. He felt good he was finally able to do all the things he ever wanted because the child on the outside finally matched the child on the inside. My nightmare had become a dream. I woke to tears on my face and pillow because Manie was happy. Happy tears turned to sad tears as I slowly realized it was just a dream. The real nightmare is what I live. The nightmare is knowing I can’t make it all better because I really can not change heartbeats with Manie.

http://www.bloomberg.com/apps/news?pid=20601087&sid=ah9mMl9sDitg

Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)

By Jef Feeley and Margaret Cronin Fisk

Sept. 15 (Bloomberg) — An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

“They said if there’s any doubt, take it out,” Tracey told jurors. “They do not want to scare anybody. It’s a very competitive marketplace. It’s a multibillion-dollar industry.”

‘Rare Thing’

Glaxo executives contend that the boy’s heart defect wasn’t caused by Paxil, Chilton Varner, one of the company’s lawyers, told jurors today in her opening statement. In court filings, Glaxo has said it appropriately tested and marketed the antidepressant drug.

“When Lyam Kilker was born in 2005, GSK had not received notice” of his specific type of heart defect in connection with Paxil use, Varner said. “The numbers will tell you the defect is a rare thing.”

The Paxil label at that time reported about animal studies, “including the rate of deaths,” she said.

Glaxo didn’t target pregnant women and its sales force didn’t use strong-arm tactics to push prescriptions, Varner said. “Whatever the marketing was, it played no role in Ms. David’s doctors’ decision to prescribe Paxil or Ms. David’s decision” to take the drug, she said.

Rat Studies

Glaxo officials purchased the compound sold as Paxil from a Danish company that had done animal studies showing young rats died after taking low doses of the drug, Tracey said in his opening statement.

One of the company’s scientists noted in internal documents in 1980 that information in the rat studies suggested Paxil “could be” a cause of birth defects, Tracey said. Still, the drugmaker refused for almost 20 years to do studies on why the young rats died, he added.

Tracey told jurors they would see documents in the trial that the company hadn’t turned over to regulators or congressional investigators. “You are going to see docs that have never seen light of day before,” he said.

For example, Tracey pointed to a 1998 internal review by Glaxo of all reports of side effects tied to Paxil and officials found “an alarmingly high number” of birth-defect reports. Even with those concerns, the report was never turned over to the U.S. Food and Drug Administration and “the alarming language” was deleted from it, the lawyer said.

In 2001, the company received a letter from a woman who used Paxil during her pregnancy and decided to abort her fetus after tests showed it had birth defects, Tracey said.

Internal Report

In analyzing the woman’s case, Glaxo officials concluded in an internal report that it was “almost certain” the fetus’s birth defects were caused by his mother’s Paxil use, the family’s lawyer added. Still, the company didn’t turn over its analysis to the FDA or beef up the drug’s warning label, Tracey said.

It wasn’t until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil increased the risk of birth defects, Tracey said.

The lawyer for David, a college nursing student who was a former cheerleader for the National Basketball Association’s Philadelphia 76ers, told jurors that Glaxo hid Paxil’s problems to protect its profits.

Paxil is “the No. 1 asset to this day this company has ever owned,” the attorney said.

‘Quite Different’

Varner said she will present “quite different” evidence on animal tests tied to Paxil.

“The animal testing did not suggest Paxil caused birth defects,” Varner said. The FDA considered the tests when it approved the drug for use by U.S. consumers in 1992, she said.

When Glaxo officials considered offering Paxil for sale in Japan, internal records show executives worried in 1994 they might have to do more safety testing on the antidepressant, said Dr. David Healy, an Irish psychiatrist testifying as an expert for Kilker’s family in the case.

It may be the “type of study we wish to avoid,” Jenny Greenhorn, an official in Glaxo’s international regulatory affairs unit, said in a memo.

Glaxo also is fighting suits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven’t been released.

New York Settlement

In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“We do not disclose our legal reserves for any specific litigation matter,” Glaxo spokesman Kevin Colgan said earlier this month.

Glaxo American depositary receipts, each representing two ordinary shares, fell 68 cents, or 1.7 percent, to $38.76 in New York Stock Exchange composite trading today. Glaxo fell 14 pence, or 1.2 percent, to 1,175.5 pence in London.

The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

To contact the reporters on this story: Jef Feeley in Philadelphia jfeeley@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

Last Updated: September 15, 2009 17:03 EDT

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

http://indibaby.wordpress.com/

http://uniteforlife.wordpress.com/2009/09/05/what-the-media-doesnt-say-about-antidepressants-pregnancy/

Here are a few excerpts:

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?

…

[T]o 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.”

…

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.

…

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.

Please read this post on Christian Delahunty’s blog indibaby.wordpress.com:

Gestational Diabetes? Our bittersweet results…

http://indibaby.wordpress.com/2009/09/04/gestational-diabetes-our-bitter-sweet-results/

I find it sad that it is so hard to find a midwife who understands the dangers of antidepressants for pregnancy. But even more difficult to grasp is how people can be so cold when dealing with parents who have lost their children to antidepressants. What is this world coming to?

If you lose a child to cancer, you never expect people to say stuff like “Sometimes kids just die” or “Your baby did not die from cancer” or “So would you like a higher dose of drugs” – no, you expect them to have compassion and understanding and sympathy. Why is it hard for people to have sympathy when someone dies from antidepressants? Instead of instantly jumping to defend the drugs, perhaps people should think about how it would feel to have the same thing happen to you.

Unfortunately I have experienced similar responses any time this subject gets brought up. I suppose that it’s beyond comprehension for people to deal with a “medication” killing someone. Or perhaps it’s only something with psychiatric drugs? I can’t imagine if I told you my grandmother died from Vioxx that anyone would start jumping to defend Vioxx.

Wake up people.

http://momsandmeds.com/

Background:

Motherhood has been hijacked by the psychopharmaceutical cartel. Last summer following the first several months of an intense grassroots campaign to stop the federal government from screening pregnant and new mothers via S. 1375 / H.R. 20, it came to our attention that La Leche League of Texas was hosting a celebratory conference in which the key note speaker would be Thomas Hale, Ph.D. and the topic would be how to help lactation counselors, consultants, and other breastfeeding leaders identify depression in breastfeeding women and inform mothers which drugs were recommended as the safest for breastfeeding.

Thus the impetus for a new sector of the UNITE / CHAADA outreach efforts began. A group of activists and experts collaborated and agreed to found and name this group “MADNAP” – Mothers Against Drugging the Nursing and Pregnant. Flyers on MedWatch data and breastfeeding studies, as well as other information obtained over the past few years regarding the risks of drugs for breastfeeding and pregnant mothers were drawn up and copied. UNITE / MADNAP activists drove to the location of the conference and distributed these flyers while Thomas Hale was inside delivering the final key note address to conclude the weekend long breastfeeding conference.

Knowing that mothers want to be able to nurse their children we feel that it is crucial that this desire not be exploited by those who seek to portray the use of potentially lethal psychotropic drugs while nursing as somehow more benign than formula feeding for the baby.

MADNAP, an affiliated group of the UNITE / CHAADA grassroots membership, has spread awareness through our BREATH blog and by other means. We have reached mothers who lost their babies to psychiatric drugs and have been able to publicize this information, leading to others having enough warning to get off of medications before or during pregnancy, potentially saving their unborn babies‘ lives.

We encourage people to share our new home page which is a launch pad to related blogs, information resources, the MedWatch reporting system, and the decrypted MedWatch data – which has been made available to the public for the first time ever, thanks to the tremendous efforts of CCHR International (and very little thanks to the FDA).

See The Bitter Pill for their press release. I have linked at the bottom of the MADNAP  site to their searchable database, including a special page on prenatal and neonatal exposure reactions / deaths.

Please check out the completed home page at http://momsandmeds.com which is also crosslisted as http://medsinmilk.com/ (yes, this is a play on the title of the book called Medications in Mother’s Milk by Thomas Hale, a book shared with lactation consultants around the world, which does not contain complete unbiased information, such as the latest MedWatch data).

Be sure to check out the yahoo group which you can locate from the MADNAP home page.

If you would like to get more involved, join the yahoo group and introduce yourself or send an email to me at amy@uniteforlife.org. Thank you for caring about babies who are currently being involuntarily drugged and whose mothers have been deprived of the right to full informed consent.

And just to fend off any accusations of me being judgmental towards women who nurse their babies on psychotropic medications, I nursed Isaac on Zoloft for four months from the time he was 6 days old. NO, I would NEVER do that again. And no, I do not judge people who do, I believe they have a right to full information before making that choice, and I know that this information has been unavailable to them, until now.

I do not want any babies to have to die the way that so many before them have, because of the misinformed and misleading statements of a few powerful and influential “experts” dictating the (incomplete) information fed to mothers.

Please help me make this viral.

I am 55 years old, the mother of four home born, breastfed, cloth diapered, healthy children.  I am the oldest of nine children, born at home and breastfed before there was a La Leche League International. My Father was a Doctor of Chiropractic and always tried to raise us in the most healthy way possible.

I always tried to learn from the mistakes of the past.  My mother was given a drug in 1953 when she was pregnant with me.  She was told it would prevent a miscarriage.  She never filled that prescription.  I was born a little early at home, but I am fine.  When I was in high school in the early 1970’s, the drug my mother was prescribed was pulled from the market because it was found to cause a very rare form of vaginal cancer, cervical abnormalities, adenosis, and testicular cancer. I had classmates in high school and college who underwent hysterectomies. I decided to learn from this mistake and live as healthfully as possible.

http://www.cdc.gov/DES/consumers/about/index.html

I taught at a private, religious school.  I loved the job!  My husband died during my fifth year the week before school began. I took no time off.  My principal suggested that I take antidepressants to help the grieving process. I was tired and depressed, so I took her advice. I went to a doctor who pulled out six weeks of free samples and a prescription for Cymbalta. He barely spoke to me for three minutes. I had never seen him before.  It was like handing out candy. He never followed up on my condition. I developed chronic constipation and joint pain from the drug; this depressed me more. I later learned that the principal is the wife of a prominent medical doctor in the community and she believes in living better through chemistry. This principal has suggested taking antidepressants to other members of the faculty – we were such a happy bunch!  I would love to see her stock portfolio and see how many pharmaceutical companies she is invested in.

I left after two years.

I finished fixing up my home the way my husband and I had discussed for years. I finished raising my young son. I took classes at the local community college.  I rested also.  This did far more to help my mood than taking pills.  I did it myself.  I wish I had taken the time to do all of this when my husband first died.  I could have saved myself a lot of grief.

Today I am happy and productive. I still get pain in my joints, but I exercise to keep limber and elevate my mood.

Mommy cuddling Indi, originally uploaded by MADNAP.

Please help us get the word out before more babies become doomed.

This is a press release from August 4 of last year, concerning an attempt on July 28 to pass The MOTHERS Act without proper procedure and due diligence via a controversial spending bill dubbed by Harry Reid and friends as the “Coburn Omnibus.” See here: http://tinyurl.com/cha9vk (See also http://christiannewswire.com/news/373117355.html )

This year, there is an attempt to include many Orwellian psych screening and treatment and intervention programs in health care reform. Congress is trying once again to pass these programs through before the August recess. We need faxes going in ASAP to your Reps and Senators. That means today! We have to do something to stop these programs from harming more babies like Indiana, and countless other vulnerable people.

Say yes to health and no to death from psychotropic drugs.

For more information on these programs please see: http://tinyurl.com/nhyhet

To take action against The MOTHERS Act specifically, please go to http://www.box.net/shared/810kj0b8g7 and print a PDF that you can fax to the Senate: http://www.box.net/shared/4qx33jhgen

Go to http://mothersact.com/ for more information.

Family Photos http://tinyurl.com/mg7y6h

It seems that Emory was originally concerned that it might be “implicated” in the scandal of the decade, after some anonymous complainer contacted them and threatened to take their concerns to the Georgia Medical Board… all because Dr. Bremner wrote on Emory letterhead that Philip Dawdy should be allowed to smoke in his own apartment.

Apparently now that Congress has decided that tobacco should be regulated by the FDA, doctors cannot make jokes about people smoking in far-off states. Heaven forbid an M.D. make a statement about the effects of nicotine withdrawal…

I wonder, if instead, I mean hypothetically speaking… someone like Zachary Stowe (after taking money from GSK while working on NIH grants) signs a letter written on Emory letterhead, composed by some PR expert at Cohn & Wolf to promote Paxil as safe for breastfeeding, a letter which is then quoted on headlines around the globe with the so-called safety information marketed to lactation specialists and OBGYNs… whether Emory would voluntarily contact Zachary Stowe and order him to stop using his position at Emory to influence medical decisions for babies in far-off states for whom he is not a primary care physician? (Hmmmm… or would it take a Senate investigation to get Emory to reprimand him?)

Wait, I think I already know the answer to that…

When it comes to telling a mature adult that he can make his own choice about smoking, that’s a medical fiasco.

But when it comes to telling a WORLD full of reporters and nursing moms that an SSRI with a BLACK BOX warning is safe to feed to a newborn baby via breast milk, that’s perfectly acceptable. Unless a Senator finds out.

Yet what really has happened to all that “research” that Stowe conducted while on the take? Self-proclaimed “experts” continue using the studies to justify pushing drugs on mothers. It remains to be seen whether and how extensively the truth will trickle down to the moms who need to know it. Most people probably continue on in ignorance, citing the same “information” pushed on breastfeeding moms for the past several years…

Hey, maybe we should give the guy a few more government grants, or cite his “research” papers a few dozen more times and send the new articles (containing the “metaanalyses” of 100 articles all of which cite Stowe’s articles as their source) in for more coverage by the PR firms and PR bloggers to use in their promotion of The MOTHERS Act, or promotions of drugging nursing moms.

Here’s how this all works: If Philip Dawdy smokes in his apartment, a neighbor might have to smell it and that would be inconvenient. And all who condone his smoking, or even poke fun at the apartment complex, should be exposed for their massive lack of “ethics.”

But if millions of childbearing or nursing women take a drug that has been shown to induce SIDS, coma, seizures, etc. according to MedWatch, the doctors responsible are… well, never held responsible. And all those who promote drugging these babies are… given awards and grants and speaking engagements. Just don’t forget to send in the paycheck on time. You don’t want to get someone irritated to the point that they start acting “like a prick.”

I wonder how much negative attention it would take to get some justice for all those dead babies out there who have people like Stowe, Cohn & Wolfe, or GSK to blame for giving their mommies the go-ahead on drugging them.

Here is a short summary of what I found recently from the FDA MedWatch reports on SSRIs, SNRIs and Zyprexa from 2004-2008. Reports of drug exposure via breast milk which did not have other side effects listed were excluded. If a drug is not listed here it’s because I only made it through the SSRIs and SNRIs and Zyprexa and got tired. Also I wanted to focus on antidepressants since those are more commonly given to moms for PPD. There are many many more psychotropic drugs being given to nursing moms, and Zyprexa is being pushed as “safe” based on a study of 7 babies.

SUMMARY

BREAST MILK ONLY EXPOSURE

First here is the information on Zoloft which is the recommended drug for breastfeeding (Prozac is the recommended drug for pregnancy).

Zoloft breast milk exposure (3 reports):
Convulsions / Epilepsy; Developmental Delay; Hypotonia

Other drugs collectively – breast milk only exposure:

SOMNOLENCE: 4 reports from breast milk alone – Prozac, Cymbalta, Lexapro and Wellbutrin
SIDS from breast milk alone – Effexor (2 reports)
Fatigue – 1 report – Paxil
Hyperreflexia – 1 Paxil
Insomnia – 1 Celexa, 1 Paxil
Gastrointestinal Disorder – 2 Paxil, 1 Celexa
Gastroesophageal Reflux Disease – 1 Celexa
Feeding Problem – 1 Lexapro
Weight Decreased – 1 Celexa
Sleep Disorder – 1 Prozac, 1 Wellbutrin
Irritability – 1 Prozac
Kidney Enlargement – 1 Paxil
Rash – 1 Paxil
Fractures – 1 Effexor
Bloody Stools / Rectal hemmorage – 1 Prozac

Pregnancy Only Exposure – Neonatal Deaths / SIDS
SIDS: 5 cases – 1 each for Celexa, Effexor, Lexapro, Wellbutrin, and Zyprexa
Neonatal Deaths: 11 cases – 3 for Celexa, 2 for Effexor, 1 Wellbutrin, 5 Zyprexa

COMBINED Breast Milk and Pregnancy Exposure
SIDS – 1 Lexapro, 1 Paxil
Autism / Sensory Integrative Dysfunction – 1 Zoloft

METHOD OF EXPOSURE NOT LISTED
SIDS – 1 Effexor (also a coma / loss of consciousness report).

This is a separate analysis looking only at SIDS, neonatal deaths, and breastfeeding exposure. This is not for every drug, just the ones listed here (SSRIs, SNRIs and Zyprexa).

This of course does not include the birth defects and heart disease adverse events, or the many many spontaneous abortions, stillbirths and intrauterine deaths. Focus is on breast milk exposure effects and prolonged pregnancy exposure effects that lead to SIDS / neonatal deaths.

This is contradictory to the claims by conflicted researchers that there are no reports of harm to breastfed infants whose mothers take Zoloft and some other drugs. Perhaps those researchers need to start admitting to the existence of MedWatch or perhaps they should pay attention to the babies being hurt by antidepressant exposure instead of pretending that those cases don’t exist.

Why are there so many more reports for pregnancy exposure-related deaths than breast milk exposure?

Several possibilities:

• People don’t believe breast milk exposure can happen because they are told the exposure is minimal or nonexistent, therefore they do not report it.
• SIDS cases are easily mistaken for suffocation or other unknown causes and thus when babies exposed to antidepressants die from SIDS drugs are not suspected (despite the fact that we know these drugs cause coma, seizures, and sedation).
• People do not know that they can report to, much less know how to report to MedWatch.
• The mothers who take antidepressants for PPD may decide to wean their babies.
• Not many moms breastfeed or do so exclusively.
• Maybe some moms wait until the baby is weaned to start an antidepressant, and only expose the next baby during pregnancy, during which time the baby dies from spontaneous abortion thus preventing any exposure via breast milk.
• Perhaps the number of women taking SSRIs, SNRIs, and Zyprexa while nursing has gone down since 2004 (reports prior to 2004 are not free) along with the black box suicide warning, thus “necessitating” a push for a national law to market drugs to chidlbearing women.

Keep in mind that MedWatch only captures 1-10% of actual adverse events (so multiply by 10 to 100 to estimate what may actually have taken place from 2004 through the 3rd quarter or so of 2008). And on the Thomas Hale breastfeeding information website for Medications in Mother’s Milk, he warns to watch out for sedation in some antidepressants. News flash – by the time you notice your baby is heavily sedated it could be too late. They could have slipped into a coma, started having seizures, or stopped breathing. Most young babies sleep a lot.

And if you do notice sedation and your baby is not in a coma or dead, your choices are: 1) wean the baby suddenly, or 2) go cold turkey off your meds while either weaning suddenly, weaning partially, or continuing to nurse while the meds leave your body, and hoping that the next feeding doesn’t send your baby into a coma, or  3) continue exposing your baby for weeks or months while you taper off. None of those is a great choice.

Go to the website for Dr. James McKenna and read up on SIDS. He theorizes that SIDS may happen when a baby is not awakened from a deep sleep often enough, and says that co-sleeping is one way that babies naturally evolved to protect themselves from SIDS. I also recall reading an article that theorizes that SIDS may be caused by a malfunctioning serotonin system. I need to go find that one again.

Needless to say if you are on antidepressants it’s a good idea to keep an eye on your baby when she sleeps, so co-sleeping would be good in that respect. However it’s also scary to think about those babies getting increased exposure from constant nursing. It’s a real catch 22.

Nestle, you can send me my check now. Ha ha just kidding. For a second I thought I had turned into Zachary Stowe.