Mother Speaks Out: Effexor, SIDS, and The MOTHERS Act

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http://uniteforlife.wordpress.com/2009/04/02/mother-speaks-out-effexor-sids-and-the-mothers-act/The short newswire version will be out very soon. Feel free to go ahead and share this longer article because it's the most informative.April 2, 2009...4:37 pmMother Speaks Out: Effexor, SIDS, and The MOTHERS Act An Interview With Christian Delahunty on Indi and The MOTHERS Actby Amy Philo“Please I beg you to learnmore. Learn everything you can while there is time… Drugs, whetherlegal or illegal, should not be used during these most precious monthsof creation.”April 2, 2009 — Christian Delahunty ofUtah believes Effexor is to blame for the death of her six-week-olddaughter Indiana, who passed away last September. Given theoverwhelming evidence on the toxicity of Effexor and other psychotropicdrugs for adults, children, and babies, it seems to be the obviouscause. But in the minds of those responsible for pushing Effexor onChristian and similar drugs down the throats of pregnant women acrossAmerica, it may be “impossible” to prove that’s the case.It is only with that mindset of denial, or simple ignorance, thatanyone could possibly justify pushing for the passage of the federallegislation called “The MOTHERS Act,” that will increase the number ofpregnant women and new mothers taking psychotropic drugs.Following the birth of her son Anaid in 2001, Christian firststarted taking antidepressants around six months postpartum - butprimarily for stress, fatigue, and trouble coping with her mother’sdeath. Eventually Christian settled on Effexor because it gave her themost energy. She says she felt medication was her only option becausenearly everyone in her family, from aunts to her mother, had been onsome kind of antidepressant and she believed that she probably sufferedfrom some sort of hereditary chemical deficiency.Although Christian had three children – Gavin, Ayla and Anaid, sheknew her mother would have wanted more grandchildren. In 2004, sheadded another baby, Jake, to her family. During that pregnancyChristian switched from Effexor to Zoloft, a milder antidepressant, ather doctor’s recommendation, but went back on Effexor after shefinished nursing.In 2007 Christian approached a new family doctor about whether sheshould switch back to Zoloft because she wanted one more baby. She wastaking 300 mg of Effexor XR (extended release). But the doctor toldher, “Oh no, you and the baby will be fine. There are no studies thatprove that the Effexor is even transferred to the baby in utero or inthe breast milk.”During her last pregnancy, Christian had developed gestationaldiabetes (a known effect of antidepressants), went into premature labortwo months early (another effect of Effexor), and had to be put on bedrest. She delivered baby Indiana a few weeks early, one month beforethe due date (37 weeks is considered full term and 38-42 is a normallength for a pregnancy).When Christian found out that the doctors planned to break her waterrather than try to stop contractions, she says that she told herhusband, “Matt you’ve got to grab me my Effexor.”The attending doctor abruptly reacted with, “What?!”This doctor, who worked with Christian’s regular OBGYN, explained toChristian and Matt that he had delivered many Effexor babies and hadseen a lot of problems. “It’s not good for the baby and it needed tobe stopped in the first trimester,” he said.Next he called and warned the NICU to get ready because an Effexor baby was coming.When Indiana was born she had trouble breathing, scored low on herAPGARs, and wouldn’t cry. Christian says she was floppy, excessivelysleepy and nearly impossible to feed, and states:“She was just a really sleepy baby andwouldn’t eat. She would eat for maybe ten minutes and fall asleep. Totry and nurse her was extremely difficult. In the NICU they would haveto shove a bottle into her mouth just to get her to have a little bit.I would have to wake her up to eat because she would go for too longand she was having problems with keeping her food down anyway. I wouldburp her and she would usually throw up most of what she would eat andI would try the other side.”Indiana spent a while in the NICUduring the hospital stay and had to be on oxygen and have an IV. Shewas also in and out of the hospital and doctor’s office after they gotto go home. Indiana had jaundice and had to be checked for bilirubinlevels four different times. She had been losing a lot of weight so shealso had to go in for numerous growth checkups.Christian says she had to work really hard to wake Indiana from adeep sleep for almost every feeding and that she had to wake her up toswitch sides. Her excessive sleepiness never improved, even by fiveweeks of age.On September 7, 2008 Christian nursed Indiana at 8 am and then puther down for a nap. Christian went back in to wake her up at 10 andfound she was not breathing.Indiana was rushed to Children’s Hospital by paramedics. The staffwas finally able to revive her after 45 minutes and she spent the nextfive days on life support. But it was too late. MRIs showed Indiana’sbrain had badly deteriorated and the family had to let her go. She diedon September 13 at six weeks of age.As reported by Vera Sharav, “In April, 2004, the National ToxicologyProgram - Center for the Evaluation of Risks to Human Reproduction(NTP-CERHR) panel issued a Report after examining all the availablepublished evidence about infants exposed to an antidepressant in uteroand / or breast fed by mothers taking an antidepressant.”Sharav continued, “The NTP-CERHR expert panel found reason for concern:Late pregnancy exposures were associated with increasedincidence of prematurity, reduced birth weight and length at full term,and poorer neonatal condition characterized by admission to specialcare nursery and adaptation problems (e.g., jitteriness, tachypnea,hypoglycemia, hypothermia, poor tone, respiratory distress, weak orabsent cry, or desaturation on feeding).“The authors concluded that the observed effects are specific to SRI exposure rather than underlying maternal depression.”This report, titled “The REPRODUCTIVE and DEVELOPMENTAL TOXICITY of FLUOXETINE”, was originally available at http://cerhr.niehs.nih.gov/news/fluoxetine/fluoxetine_final.pdf.As if the conclusions of the report were not bad enough, variousstudies demonstrate that antidepressants double spontaneous abortionsand stillbirths and quintuple preterm births. Babies exposed to SSRIshave a six-fold increased risk of persistent pulmonary hypertension(PPHN), a potentially fatal lung problem. Nearly a third of women whotake SSRIs have a baby who dies, is premature or underweight, or whohas seizures.It seems that certain sectors of the medical industry aren’t payingattention. From 2004-2008 (through the 2nd quarter only) the FDAMedWatch Adverse Events Reporting Database amassed 325 adverse reactionreports for prenatal or neonatal Effexor exposure, including 6 reportsof Sudden Infant Death Syndrome (SIDS). One Effexor-SIDS case wasspecified as a breast milk exposure only, while four were listed aspregnancy exposure. For the other, with a coma followed by SIDS, thetiming of exposure was not specified.There were also 21 intrauterine deaths, 2 neonatal deaths, 2stillbirths, and numerous other fatal or life-threatening birthdefects, for a total of 67 deaths from Effexor alone, not counting theprenatal and neonatal deaths caused by the numerous other psychotropicdrugs taken by women during pregnancy or breastfeeding over those fouryears.Multiply these totals by a factor of between 10 and 100, because theFDA estimates that only 1-10% of adverse reactions are ever reported.(To see the 2004-2008 reports go to http://www.psychdrugdangers.com/MothersAct.html and then select SNRIs, and Venlafaxine from the drug tables.)The American Academy of Pediatrics publishes and disseminates a longlist of drugs that “may be of concern” in breastfed infants. The tablesalso appear in The Breastfeeding Answer Book (BAB) published by LaLeche League (2003), which is given to leaders and subsequently used tocounsel nursing mothers when they request information about drugs andbreastfeeding.In these tables, following a list of psychotropic drugs that “may beof concern” but nonetheless are claimed to have “no reported effects,”is a list of “Food and Environmental Agents” that have effects onbreastfeeding. On the list are aspartame (NutraSweet) with the warning,“Caution if mother or infant has phenylketonuria” and a “VegetarianDiet” with the warning, “Signs of B12 deficiency.”It’s good to warn women about aspartame and diet, but what aboutdrugs that do not have giant warnings plastered on them like NutraSweetdoes with PKU?Effexor is not listed anywhere in the AAP drug tables. It seemspsychotropic drugs must be incredibly safe in the mind of the Academybecause even though numerous patients have nursed babies on the newantidepressants in the last two decades, there are apparently “noreports” of adverse effects on babies for most of them, at leastaccording to the AAP.“Drugs of Abuse” such as Amphetamine and Cocaine, Heroin andMarijuana are listed in the table with side effects identical to thoselisted for antidepressants in current warnings. These same side effectsare absent from the AAPs tables for prescription psychotropics, with the exception of Prozac and a few antipsychotics.The effects of street drug on infants include “Irritability, poorsleeping pattern” for Amphetamine, “Cocaine intoxication, irritability,vomiting, diarrhea, tremulousness, and seizures” for Cocaine, “Tremors,restlenssness, vomiting, poor feeding” for heroin, and none reportedfor Marijuana.Prozac must be the only unlucky antidepressant that’s bad for breastfed infants,even though according to Thomas Hale, Ph.D. and kellymom.com (abreastfeeding information site), it’s the only antidepressant that’s“recommended” for pregnancy. Prozac side effects listed in the BAB for nursing infants include colic, irritability, feeding and sleep disorders, and slow weight gain. Although in a 2002 Mothering Magazine article titled “But Is It Safe For My Baby? Medications andBreastfeeding,” Dr. Hale wrote that Prozac had been shown to induce coma in breastfed infants.According to kellymom.com’s summary of Dr. Hale’s recommendations,“Effexor can also be used in breastfeeding mothers if it isefficacious. It may be effective against hyperactivity.”However, kellymom.com later implies that Celexa is no safer thanEffexor even though it’s an SSRI and therefore supposedly “weaker”because “There have been two cases of excessive somnolence, decreased feeding, and weight loss in breastfed infants,” according to Hale.Kellymom.com does note that, “Lithium use by the breastfeeding mother is dangerous to the breastfed infant. Valium use by the breastfeeding mother entails a greater risk of infant sedation, and may perhaps increase the risk of SIDS.”Finally, a “Drug Heirarchy” of Hale’s first to last choice is listed as: Zoloft, Paxil, Celexa, Effexor, and Prozac.“Dr. Hale concluded his talk by saying that breastfeeding should besupported fully and not interrupted by mom’s needs for medication; andthat treatment of postpartum depression can be accomplished relativelysafely in breastfeeding mothers. So, in his consideration, moms shouldcontinue breastfeeding and should get drug treatment as needed fordepression.”http://www.kellymom.com/health/meds/antidepressants-hale10-02.html#EffexorHowever according to Candace S. Brown, PharmD, BCPP, CFNP, writing for femalepatient.com, “Illet et al studied three cases of breast-feeding women using venlafaxine [Effexor], and reported M/P ratios of up to 4.7.28…Given their high M/P ratios and the limited amount of informationavailable on these antidepressants [venlafaxine, bupropion, trazodone,and nefazodone], they are not recommended in lactating women at this time.”Milk-to-Plasma Ratio: Medicationconcentration in milk is frequently compared with the concentration inmaternal serum to quantify the extent of passage; this is known as themilk-to-plasma ratio (M/P). In general, compounds that are weaklyprotein-bound, highly lipid-soluble, weakly basic, and small inmolecular size have higher M/P ratios. Ratios greater than 1 indicate that the medication is present in higher concentrations in breast milk than in maternal serum. The higher the M/P ratio, the greater the infant exposure to medication.http://www.femalepatient.com/html/arc/sig/pharma/articles/article_3.aspThe article further explains that:Infants’ abilities to absorb, metabolize, and eliminate drugs determine how these drugs will affect them. Comparedwith adults, infants have a higher gastric pH, causing basic compounds,which remain un-ionized, to have higher absorption rates than do acidic compounds. Infantsalso have lower levels of albumin, resulting in higher amounts offree/unbound (and therefore active) medication. Liver metabolic enzymesare immature in infants, decreasing the rate of degradation ofmedication. In addition, neonates’ kidneys have a glomerular filtration rate that is 30% to 40% of that in adults. Finally, the blood-brainbarrier in newborns is not fully developed, and central nervous systemconcentrations of some lipid-soluble compounds may reach levels thatare 10 to 30 times those in serum. As a result of all of these factors, medications that reach the serum in neonates, as compared with those that reach the serum of adults or children older than 6 months, are more likely to be active, less likely to be metabolized and excreted, and more likely to cross into the brain.Given the confusing and contradictoryinformation found with so many varying sources, whether it’s their LaLeche League leader or lactation consultant, a magazine article, oreven a breastfeeding website, most new mothers will probably ask for aprofessional opinion from a doctor or pharmacist. Either one should bereadily able to offer the following information straight from theEffexor label, which can be found by merely “Googling” Effexor inbreastfeeding or pregnancy:[Effexor during pregnancy in animal studies resulted in a] “decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known. Venlafaxine appears to cross the human placenta near term.In a prospective study pregnancy outcomes of 150 women exposed to venlafaxine during first trimester were compared with the pregnancy outcomes of a group of pregnant women who received selective serotonin reuptake inhibitor antidepressants and a group of women who received nonteratogenic drugs. The majority of the women in the venlafaxine group took 75 mg/day (range 37.5 to 300 mg/day) of venlafaxine immediate release form. Among the 150 women who were exposed to venlafaxine during pregnancy, 125 had live births, 18 had spontaneous abortions and seven had therapeutic abortions; two of the babies had major malformations.Yet when Christian Delahunty approachedher family doctor about switching from Effexor to a differentmedication when she wanted to have another baby, she was told thatthere were “no studies” showing that Effexor even gets to the babyduring pregnancy or breastfeeding. According to Christian, the maximumdose of extended release Effexor is 225 mg. She was on 300 mg at thestart of her pregnancy and throughout Indi’s life.Perhaps Christian’s OBGYN and family doctor only recently graduatedfrom medical school, or maybe they both had gone on vacation and missedreading emails when the FDA MedWatch and Wyeth issued a warning letteron June 28, 2004, specifically for doctors on the dangers of Effexor inpregnancy and stated in part, “Neonates exposed to Effexor, other SNRIs(Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (SelectiveSerotonin Reuptake Inhibitors), late in the third trimester ofpregnancy have developed complications requiring prolongedhospitalization, respiratory support, and tube feeding.”Today, Christian spends the days coping with the loss of herdaughter but says she feels inspired by baby Indi to help others nothave to go through the same tragedy. Christian switched to Lexaproafter Indiana died because she wanted nothing to do with Effexor, andthen started tapering off the drug slowly. Her last dose was four daysago. Already she says, “I am actually starting to feel better because Idon’t feel so controlled by a substance… If you don’t take your dose itaffects you horribly. This is the first time I’ve been sober in 8years. It makes me want to cry because it did have so much effect onevery part of your life. I was just on a rollercoaster ride, that’swhat it feels like.”“I cope by just praying to God, and in my mind having conversationswith Indi. I have an incredible support system and I have to believe -and I think one of the biggest things helping me through this - is thatI believe this was her purpose. We had to go through what we had tobecause she needed to make a difference. She needed to help otherpeople realize that this is serious and it is real.”“I told my OBGYN at my first consultation that I was on Effexor andshe didn’t think there was anything wrong with it. Throughout thepregnancy, I had my doubts and my first instinct was that this wasn’tright, but I was being told that it was just fine. The deliveringdoctor brought up Effexor. After Indi passed away the thought just keptcoming back to me and then I started doing my research and found outhow dangerous it was. I Googled Effexor baby, Effexor dangers, Effexorand pregnancy… I was so shocked because it was so easy to do that and Ishould have done that before. Why didn’t the doctors know that? Thereis so much controversy over it, why don’t the doctors research moreinto it without taking the rep’s point of view saying it’s just fine?”When asked what she thinks about The MOTHERS Act, Christian said:“It puts so many babies at risk for developing so many differentproblems. And it puts the mother at risk. Postpartum is normal, it’snatural. It’s learning how to cope with your stress and your situation,rather than just taking drugs to forget about it or to mask what’snatural. There are so many people out there who I know are thinkinglike I thought – you either have family members on antidepressants oryou know somebody - it’s just kinda normal, you know we’ll all starttaking an antidepressant… Just because it’s prescribed from a doctor itdoesn’t make it safe.”“I trusted my doctor and that mistake - it cost me. It cost my wholeentire family. That is why I have to believe that this was Indi’spurpose. Educate yourselves. If the doctors aren’t going to be educatedthen we need to. We need to take the power back.”By the way, the March of Dimes, a pharma-funded group that endorsesThe MOTHERS Act as well as the use of antidepressants during pregnancy,does warn against the use of caffeine in pregnancy due to a risk ofmiscarriage.To learn more about the dangers of “The MOTHERS Act,” go to uniteforlife.org.Please go to this link to watch a video in memory of baby Indiana: http://www.youtube.com/watch?v=bYYHubjrhB4Sincerely,Amy Philo214-705-0169 home817-793-8028 cellJoin the Coalition! Sign the Petition! StopThe MOTHERS Act!uniteforlife.org

 

 

 

 

 

 

 

 

 

 

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