SIDS, Neonatal Deaths, and Breast Milk Exosure-Related Adverse Event Reports to MedWatch
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.
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 / – 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?
- 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.