Grieving Mother Christian Delahunty Warns Others About Effexor During Pregnancy and Breastfeeding
by Amy Philo
“Please I beg you to learn more. Learn everything you can while there is time… Drugs, whether legal or illegal, should not be used during these most precious months of creation.”
April 2, 2009 — Christian Delahunty of Utah believes Effexor is to blame for the death of her six-week-old daughter Indiana, who passed away last September. Given the overwhelming evidence on the toxicity of Effexor and other psychotropic drugs for adults, children, and babies, it seems to be the obvious cause. But in the minds of those responsible for pushing Effexor on Christian and similar drugs down the throats of pregnant women across America, it may be “impossible” to prove that’s the case.
It is only with that mindset of denial, or simple ignorance, that anyone could possibly justify pushing for the passage of the federal legislation called “The MOTHERS Act,” that will increase the number of pregnant women and new mothers taking psychotropic drugs.
Following the birth of her son Anaid in 2001, Christian first started taking antidepressants around six months postpartum – but primarily for stress, fatigue, and trouble coping with her mother’s death. Eventually Christian settled on Effexor because it gave her the most energy. She says she felt medication was her only option because nearly everyone in her family, from aunts to her mother, had been on some kind of antidepressant and she believed that she probably suffered from some sort of hereditary chemical deficiency.
Although Christian had three children – Gavin, Ayla and Anaid, she knew her mother would have wanted more grandchildren. In 2004, she added another baby, Jake, to her family. During that pregnancy Christian switched from Effexor to Zoloft, a milder antidepressant, at her doctor’s recommendation, but went back on Effexor after she finished nursing.
In 2007 Christian approached a new family doctor about whether she should switch back to Zoloft because she wanted one more baby. She was taking 300 mg of Effexor XR (extended release). But the doctor told her, “Oh no, you and the baby will be fine. There are no studies that prove that the Effexor is even transferred to the baby in utero or in the breast milk.”
During her last pregnancy, Christian had developed gestational diabetes (a known effect of antidepressants), went into premature labor two months early (another effect of Effexor), and had to be put on bed rest. She delivered baby Indiana a few weeks early, one month before the due date (37 weeks is considered full term and 38-42 is a normal length for a pregnancy).
When Christian found out that the doctors planned to break her water rather than try to stop contractions, she says that she told her husband, “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 to Christian and Matt that he had delivered many Effexor babies and had seen a lot of problems. “It’s not good for the baby and it needed to be 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 her APGARs, and wouldn’t cry. Christian says she was floppy, excessively sleepy and nearly impossible to feed, and states:
“She was just a really sleepy baby and wouldn’t eat. She would eat for maybe ten minutes and fall asleep. To try and nurse her was extremely difficult. In the NICU they would have to 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 long and she was having problems with keeping her food down anyway. I would burp her and she would usually throw up most of what she would eat and I would try the other side.”
Indiana spent a while in the NICU during the hospital stay and had to be on oxygen and have an IV. She was also in and out of the hospital and doctor’s office after they got to go home. Indiana had jaundice and had to be checked for bilirubin levels four different times. She had been losing a lot of weight so she also had to go in for numerous growth checkups.
Christian says she had to work really hard to wake Indiana from a deep sleep for almost every feeding and that she had to wake her up to switch sides. Her excessive sleepiness never improved, even by five weeks of age.
On September 7, 2008 Christian nursed Indiana at 8 am and then put her down for a nap. Christian went back in to wake her up at 10 and found she was not breathing.
Indiana was rushed to Children’s Hospital by paramedics. The staff was finally able to revive her after 45 minutes and she spent the next five days on life support. But it was too late. MRIs showed Indiana’s brain had badly deteriorated and the family had to let her go. She died on September 13 at six weeks of age.
As reported by Vera Sharav, “In April, 2004, the National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) panel issued a Report after examining all the available published evidence about infants exposed to an antidepressant in utero and / 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 increased incidence of prematurity, reduced birth weight and length at full term, and poorer neonatal condition characterized by admission to special care nursery and adaptation problems (e.g., jitteriness, tachypnea, hypoglycemia, hypothermia, poor tone, respiratory distress, weak or absent 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, various studies demonstrate that antidepressants double spontaneous abortions and stillbirths and quintuple preterm births. Babies exposed to SSRIs have a six-fold increased risk of persistent pulmonary hypertension (PPHN), a potentially fatal lung problem. Nearly a third of women who take SSRIs have a baby who dies, is premature or underweight, or who has seizures.
It seems that certain sectors of the medical industry aren’t paying attention. From 2004-2008 (through the 2nd quarter only) the FDA MedWatch Adverse Events Reporting Database amassed 647 adverse reaction reports (amounting to 432 babies’ cases, since some reactions are reported by lawyers, doctors and consumers for the same child) for prenatal or neonatal Effexor exposure, including four reports of Sudden Infant Death Syndrome (SIDS). Two Effexor-SIDS cases were specified as a breast milk exposure only, while one was listed as pregnancy exposure. For the other, with a coma followed by SIDS, the timing of exposure was not specified.
There were also 18 intrauterine deaths, 2 neonatal deaths, 2 stillbirths, 51 miscarriages (spontaneous abortions), and numerous other fatal or life-threatening birth defects, for a total of at least 77 deaths from Effexor alone, not counting the prenatal and neonatal deaths caused by the numerous other psychotropic drugs taken by women during pregnancy or breastfeeding over those four years.
Multiply these totals by a factor of between 10 and 100, because the FDA 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 long list of drugs that “may be of concern” in breastfed infants. The tables also appear in The Breastfeeding Answer Book (BAB) published by La Leche League (2003), which is given to leaders and subsequently used to counsel nursing mothers when they request information about drugs and breastfeeding.
In these tables, following a list of psychotropic drugs that “may be of concern” but nonetheless are claimed to have “no reported effects,” is a list of “Food and Environmental Agents” that have effects on breastfeeding. On the list are aspartame (NutraSweet) with the warning, “Caution if mother or infant has phenylketonuria” and a “Vegetarian Diet” with the warning, “Signs of B12 deficiency.”
It’s good to warn women about aspartame and diet, but what about drugs that do not have giant warnings plastered on them like NutraSweet does with PKU?
Effexor is not listed anywhere in the AAP drug tables. It seems psychotropic drugs must be incredibly safe in the mind of the Academy because even though numerous patients have nursed babies on the new antidepressants in the last two decades, there are apparently “no reports” of adverse effects on babies for most of them, at least according to the AAP.
“Drugs of Abuse” such as Amphetamine and Cocaine, Heroin and Marijuana are listed in the table with side effects identical to those listed for antidepressants in current warnings. These same side effects are 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, poor sleeping pattern” for Amphetamine, “Cocaine intoxication, irritability, vomiting, diarrhea, tremulousness, and seizures” for Cocaine, “Tremors, restlenssness, vomiting, poor feeding” for heroin, and none reported for 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 (a breastfeeding 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 and Breastfeeding,” 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 is efficacious. It may be effective against hyperactivity.”
However, kellymom.com later implies that Celexa is no safer than Effexor 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 Hierarchy” 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 be supported fully and not interrupted by mom’s needs for medication; and that treatment of postpartum depression can be accomplished relatively safely in breastfeeding mothers. So, in his consideration, moms should continue breastfeeding and should get drug treatment as needed for depression.”
However 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 information available on these antidepressants [venlafaxine, bupropion, trazodone, and nefazodone], they are not recommended in lactating women at this time.”
Milk-to-Plasma Ratio: Medication concentration in milk is frequently compared with the concentration in maternal serum to quantify the extent of passage; this is known as the milk-to-plasma ratio (M/P). In general, compounds that are weakly protein-bound, highly lipid-soluble, weakly basic, and small in molecular 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.
The article further explains that:
Infants’ abilities to absorb, metabolize, and eliminate drugs determine how these drugs will affect them. Compared with adults, infants have a higher gastric pH, causing basic compounds, which remain un-ionized, to have higher absorption rates than do acidic compounds. Infants also have lower levels of albumin, resulting in higher amounts of free/unbound (and therefore active) medication. Liver metabolic enzymes are immature in infants, decreasing the rate of degradation of medication. In addition, neonates’ kidneys have a glomerular filtration rate that is 30% to 40% of that in adults. Finally, the blood-brain barrier in newborns is not fully developed, and central nervous system concentrations of some lipid-soluble compounds may reach levels that are 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 contradictory information found with so many varying sources, whether it’s their La Leche League leader or lactation consultant, a magazine article, or even a breastfeeding website, most new mothers will probably ask for a professional opinion from a doctor or pharmacist. Either one should be readily able to offer the following information straight from the Effexor label, which can be found by merely “Googling” Effexor in breastfeeding 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 approached her family doctor about switching from Effexor to a different medication when she wanted to have another baby, she was told that there were “no studies” showing that Effexor even gets to the baby during pregnancy or breastfeeding. According to Christian, the maximum dose of extended release Effexor is 225 mg. She was on 300 mg at the start of her pregnancy and throughout Indi’s life.
Perhaps Christian’s OBGYN and family doctor only recently graduated from medical school, or maybe they both had gone on vacation and missed reading emails when the FDA MedWatch and Wyeth issued a warning letter on June 28, 2004, specifically for doctors on the dangers of Effexor in pregnancy and stated in part, “Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.”
Today, Christian spends the days coping with the loss of her daughter but says she feels inspired by baby Indi to help others not have to go through the same tragedy. Christian switched to Lexapro after Indiana died because she wanted nothing to do with Effexor, and then started tapering off the drug slowly. Her last dose was four days ago. Already she says, “I am actually starting to feel better because I don’t feel so controlled by a substance… If you don’t take your dose it affects you horribly. This is the first time I’ve been sober in eight years. It makes me want to cry because it did have so much effect on every part of your life. I was just on a rollercoaster ride, that’s what it feels like.”
“I cope by just praying to God, and in my mind having conversations with 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 that I believe this was her purpose. We had to go through what we had to because she needed to make a difference. She needed to help other people realize that this is serious and it is real.”
“I told my OBGYN at my first consultation that I was on Effexor and she didn’t think there was anything wrong with it. Throughout the pregnancy, I had my doubts and my first instinct was that this wasn’t right, but I was being told that it was just fine. The delivering doctor brought up Effexor. After Indi passed away the thought just kept coming back to me and then I started doing my research and found out how dangerous it was. I Googled Effexor baby, Effexor dangers, Effexor and pregnancy… I was so shocked because it was so easy to do that and I should have done that before. Why didn’t the doctors know that? There is so much controversy over it, why don’t the doctors research more into 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 different problems. And it puts the mother at risk. Postpartum is normal, it’s natural. 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’s natural. There are so many people out there who I know are thinking like I thought – you either have family members on antidepressants or you know somebody – it’s just kinda normal, you know we’ll all start taking an antidepressant… Just because it’s prescribed from a doctor it doesn’t make it safe.”
“I trusted my doctor and that mistake – it cost me. It cost my whole entire family. That is why I have to believe that this was Indi’s purpose. Educate yourselves. If the doctors aren’t going to be educated then we need to. We need to take the power back.”
By the way, the March of Dimes, a pharma-funded group that endorses The MOTHERS Act as well as the use of antidepressants during pregnancy, does warn against the use of caffeine in pregnancy due to a risk of miscarriage.
Note: This article was updated with the latest MedWatch information on July 28,2009. For more reports on drugs commonly given to nursing mothers such as antidepressants and Zyprexa, go to http://momsandmeds.wordpress.com/2009/06/24/breastmilkexposure/