Magnesium Sulfate has long been used in obstetrics to prevent seizures associated with pre-eclampsia, eclampsia, pregnancy induced hypertension and preterm labor. On May 30, 2013, the United States Food and Drug Administration issued a drug safety alert stating that clinicians should not prescribe Magnesium Sulfate for seizure prevention during pregnancy for more than 5-7 days because of the risk of low calcium and bone abnormalities in the fetus.
Magnesium Sulfate has been used for decades ”off label ” (not for its originally FDA approved indication) for the prevention of preterm labor and the prevention of seizures caused by markedly increased blood pressure as seen in pre-eclampsia and eclampsia. It was first prescribed in Germany in 1906 to prevent seizures associated with eclampsia and was injected into the intrathecal cavity (at the base of the spine). In 1926 it was prescribed intra-muscularly and in 1933, the IV form of “Mag Sulfate” became available.
As recently as February 2013, researchers published a study touting the benefits of Magnesium Sulfate and saying that there were no appreciable side effects. Upon close scrutiny of the article, one clearly sees that this particular study only addressed potential side effects to the mother. This study, like many others, completely ignored the potential harm to the developing fetus, assuming that if magnesium sulfate is in fact safe for mamas it is safe for babies. This simply isn’t the case.
In response to 18 adverse drug reports submitted to the Safety Information and Adverse Event Reporting system, the FDA conducted its own research to see why some mothers had problems and some did not. Babies born to these 18 women all had osteopenia (low bone mass density) and were at greater risk of sustaining fractures. The average amount of time the mamas received Magnesium sulfate was over a 10 weeks. The FDA found that the maximum time that a mamas should take Magnesium Sulfate is a mere 5-7 days and then the FDA recommends stopping the medication. The prolonged administration of Magnesium Sulfate led to the side effects, which seem to resolve once Magnesium Sulfate is stopped.
This MedScape News Report has a couple of really good take home messages. First and foremost, clinicians must closely monitor Magnesium Sulfate administration and ensure that mamas understand that the drug is being used off label, has the potential to affect their unborn babies’ bones and that they have the right to say “no”. Second, we health care researchers have to be careful when reading studies lest we draw false conclusions and inform the public that there is no harm when there is or there is harm when there is not.
MedScape News: http://www.medscape.com/viewarticle/805009
Jeffrey Michael Smith, Richard F Lowe, Judith Fullerton, Sheena M Currie, Laura Harris and Erica Felker-Kantor
An integrative review of the side effects related to the use of magnesium sulfate for pre-eclampsia and eclampsia management. BMC Pregnancy Childbirth, May 2013
One of the perks of what I do is that I get to view and screen a lot of material as it is just hitting the market. A few weeks ago I was asked to review The Complete Guide to Medications During Pregnancy & Breastfeeding and received a complimentary copy. This guide is by Carl P. Weiner, MD, a perinatologist and Kate Rope, a journalist and health writer. I have to admit, once I review many of the books and things I receive, I forward them on to you mamas. But I am sorry to say no one is getting this guide-I’m keeping it! It’s an excellent resource!!!
This is the type of guide I would have loved to have had while I was a practicing Physician Assistant or even when I was having my own children. It is a large book, but it is so well organized and comprehensive, I quickly lost sight of the size and focused on the information. There are a few short chapters at the beginning; the introduction from the authors, why they wrote the book, how medications work in pregnancy and breastfeeding and how to take care of yourself and your baby. The rest of the book is literally a listing of hundreds of over the counter and prescription medications, their indications, potential side effects and then pregnancy and lactation categories. It’s similar to the Physicians Desk Reference (PDR) but I think far easier to find what you need and the drug facts are far easier to read and understand.
I know many of you mamas are against taking any sort of medications. That is fine. But if you are prescribed something or are wondering what you can take if you have a little cold, this is a GREAT BOOK to refer to! For example, you can look up something like pseudoephedrine (Sudafed) and get the complete rundown on the drug and whether or not its safe in pregnancy and lactation.
I did wonder why some heavy duty medications were included, some that to me seemed very unlikely to be used during pregnancy and breastfeeding. However, there are always emergencies and/or complications and if a mama is prescribed a medication, it’s great that she can get some quick information that is complete and easy to read and understand as she makes her treatment decisions.
This guide is not for everyone. But for those of us who want to know “every little detail” (I am speaking about myself here!!) the $29.99 investment is nothing for the information and peace of mind. The book is available at the Mamas on Bedrest Bookstore, Amazon.com, Barnes and Noble.com, Walmart.com and from the publisher, St. Martin’s Press.
While Today is April Fool’s Day, the news below is certainly no joke. Yet another study has reported that low levels of Vitamin D in pregnant women is associated with adverse pregnancy outcomes.
Fariba Aghajafari, MD, CCFP, and colleagues from the University of Calgary in Alberta, Canada, published their findings after performing a systematic review and meta-analysis of the available data online March 26 in in the British Medical Journal. Reviewing data from studies published on MEDLINE, PubMed, Embase, CINAHL, the Cochrane Database of Systematic Reviews and the Cochrane database of registered clinical trials, the researchers reviewed 31 studies and found the following results:
- Low levels of 25-OHD Vitamin D (the best indicator of Vitamin D status in Humans) is associated with increased risk of Gestational Diabetes
- Low levels of 25-OHD Vitamin D is associated with increased risk of pre-eclampsia
- Low levels of 25-OHD Vitamin D is associated with small for gestational age infants.
And these findings are only from this one study! We here at Mamas on Bedrest & Beyond have reported in several of our blog posts the effects of low levels of Vitamin D and adverse pregnancy outcomes. Here is what we have found in the literature to date:
- Low levels of Vitamin D are associated with Post Partum Depression.
- Low levels of Vitamin D are associated with Gestational Diabetes
- Low levels of Vitamin D are associated with Pre-Eclampsia
- Low levels of Vitamin D are associated Low Birth Weight and Asthma in the Baby
We have also found that while current medical recommendations are only 200-400 IU of Vitamin D for daily supplementation, Studies we have seen recommend far more for optimum function (upwards of 2000-4000IU daily).
So what should you do with all of this information? Talk To Your Doctor!! While you may initially experience a bit of push back from your OB, if you bring in these citations, they will take you seriously. Leading medical experts are recognizing the importance of Vitamin D supplementation and noting that the vast majority of individuals in the United States are deficient. Interestingly enough, darker skinned people are at increased risk of Vitamin D Deficiency because Vitamin D is absorbed through the skin from the sun and darker skin protects against penetration from the sun’s rays, so less Vitamin D is absorbed by darker skinned individuals.
Personally, I think that there is a growing body of evidence to support Vitamin D supplementation. The question becomes, at what dose? You will have to discuss this with your doctor. My guess is that optimum dosage may have to be done individually and for that, you may need to have blood levels of Vitamin D assessed in order to figure out how much (if any) supplementation you need.
I warn you now that not all OB’s have jumped on the Vitamin D bandwagon. Many are content to simply prescribe a prenatal vitamin and leave it at that as they, “Don’t believe the hype”. But I suggest to you that if you are at increased risk for any of he aforementioned conditions for which low vitamin D levels increase the risk, then at the very least a discussion with your physician is in order. It may not be the ultimate cure for what ails you, but if it can help you decrease your risk of pregnancy complications and adverse outcomes, a simple pill or 2 a days seems easy enough for your OB to prescribe and for you to take, and there is little to no risk of toxicity or overdose.
Talk with your doctor about your Vitamin D levels and see if you need supplementation. It’s easy, and it may well vastly improve your health, the health of your baby and your ability to have a healthy, full term infant.