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SIDS, Neonatal Deaths, and Breast Milk Exosure-Related Adverse Event Reports to MedWatch

June 24, 2009

I’ve been pretty quiet lately, because I am trying to update and synthesize several years worth of observations and research on the effects of psychotropic drugs on breastfed babies. It’s a big task.

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.

10 Comments leave one →
  1. July 3, 2009 1:55 pm

    Amy,

    I think the best option for moms, especially those who have been taking antidepressants for years, is to gradually wean the meds, while supplementing formula at key times during the day. The research has already been done to prove that the drugs are in the moms bloodstream/breastmilk in concentrated forms after taking the meds.

    Moms could supplement formula and keep nursing while gradually weaning down to the lowest dose, and hopefully getting completely off the drug within a six to eight month span.

    For those moms who plan to nurse the baby for the long haul – until the baby wants to stop – (and for me this was years with four of my children), this would be what I would do in that same situation.

    Breastfeeding is about so much more than physical food, and I would hate for any Mother to feel like she has to completely wean and go to formula because she was ignorant about the risks from antidepressants.

    Nursing a child might be the exact motivation she needs to get off the meds.

    I know the desire to have my second child was the main motivator that impelled me to get off the meds and look for natural alternatives nineteen years ago!

    Jenny Hatch

    • July 3, 2009 10:44 pm

      If the mom wants to continue breastfeeding the only truly safe option would be pumping and dumping until the meds are completely out of her system. Of course it will be hard for the mom and baby but not quite as hard as burying your baby. Just ask Christian Delahunty what she would do if she had it to do over again. There are some protocols for sudden withdrawal that might help with symptoms and some people can get through cold turkey withdrawal but that can be very dangerous for the mother, can cause suicide or homicide like in Andrea Yates’ case, or seizures, etc.

  2. July 6, 2009 1:57 am

    Amy,

    I know it is a total mixed bag overall. I was just thinking about the women, and there are many of them, who have been lied to for the past twenty years and told the drugs are safe during pregnancy/lactation and perhaps have been on them for years and now believe that they must wean in order to save the babe and/or suddenly stop taking the meds.

    With the rebound psychosis and mania so high for people who try to come off the meds, I’m not sure that sudden weaning and withdrawal from the meds is best for the mother and the baby.

    I was just writing what I would do in that situation. But each mother has to thoughtfully ponder it and then make the best decision for her family.

    As I said, breastfeeding is about so much more than food. But you are much more educated than me on the toxicity side of this issue. So, if you think it is best for the Mom to pump and dump while she slowly comes off the meds, that is probably best.

    Coming off Prozac was the hardest thing I have ever done. I am so grateful I had been off for over a year before we conceived our second child.

    Jen

    • Amy Philo permalink
      July 6, 2009 3:55 pm

      Coming off of Zoloft over several weeks was difficult only because of the withdrawal symptoms (worse than just staying on the med) but I was better once it was out of my system completely. Some people have horrid problems and cannot get off. Most moms don’t breastfeed for very long so the amount of women who have to make that choice is pretty small. I am very thankful nothing horrible happened to Isaac since I nursed him on Zoloft for four months. But if I had to make that choice right now I would probably try to find out what the milk / plasma ratio is and consider the dose I was on. It only took me 3 weeks to a month to get off Zoloft, so that would have been a reasonable time to pump and dump. But pumping and dumping for 6-8 months would be ridiculous. In the first place, most moms who are on these meds and decide to get off cannot get good information from a doctor, and they can’t get it from Thomas Hale, or a LLL leader, or pretty much anywhere. Everyone has to make their own decision. But knowing what I do know, if I was on a high dose of an antidepressant and then found out that babies have died from SIDS at a young age from these drugs, I don’t think I could handle nursing on the drug for months while weaning off. Breast milk and breast feeding are best but when you consider that babies like Indiana have died while being nursed on these drugs (Indiana stopped breathing at 5 weeks) and that they don’t have months to go, I am sure the mother would prefer formula feeding than a dead baby.

      I am not trying to tell women what to do or tell them not to breastfeed. As you know I am a huge breastfeeding advocate. But I am just being honest. I hate the idea of weaning a baby that young, but I hate the idea of the baby dying even more. The best choice is to not use the drug in the first place, and if you are already on it, the best choice is to minimize / discontinue exposure to your baby if possible.

      I was nursed for over two years and so were my children. I nursed a baby on Zoloft. So I know what it’s like… but I don’t know what it’s like to lose a child and I hope I never have to know that. I am very thankful for what I have.

  3. Rebecca permalink
    May 4, 2011 3:32 pm

    Hey,
    I am exclusively breastfeeding and my little son is 8 weeks old today. I have just been prescribed Lexapro 10mg today. I took half of one tonight. I’m terrified of SIDS, naturally. Do you think my baby is at risk of SIDS now that I’m taking Lexapro? :(

  4. March 17, 2012 5:32 am

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  5. March 22, 2012 9:22 am

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