Q:  Is it safe for a pregnant woman to take true hope Empower plus supplements?
 
Dear Elizabeth --
Short answer: possibly.  Long answer: think about what it takes to demonstrate that anything is safe to take during pregnancy.  You need a woman who is only taking the substance in question, not a bunch of other things that will confuse matters.  She needs to have been taking it at the time she became pregnant.  And you need details on how things turned out, including when things were normal.

One of the pharmaceutical products, lamotrigine (Lamictal), has a "registry" of such cases that has recently reached about 1000 women.  That is one of the largest registries of its kind.  For comparison, another registry of olanzapine (Zyprexa) has a few hundred women.  Yet despite these numbers, we can only reach tentative conclusions about the safety of these compounds.  Imagine if a medication causes a birth defect data rate of about one per thousand pregnancies.  You would need a registry of a thousand women to even see one such event, and that would be hard to distinguish from the background rate of abnormalities in pregnancies, which is at about that same rate.  So really you would need several thousand pregnancies -- again, exposed only to that single agent, from the very beginning of pregnancy, with information about outcomes.  Very hard to obtain. 

Lamotrigine was looking pretty good for a while, with no clear indication of a risk in pregnancy.  But it was recently found "unsafe" when the rate of cleft palate abnormalities was found to be  a little over 2% of births on lamotrigine, versus a little less than 1% of births not so exposed (Holmes and colleagues; the precise figures are 2.3% versus 0.7%).  The point is, you need an awful lot of pregnancies with that single exposure to be able to find this kind of frequency shift. 

So, to return to the issue of the True Hope supplement: as you can see, with many fewer women taking only that compound when they become pregnant, it is going to take years before we will know the answer to your question (and even then, we will only have a rough sense, as outlined above).  What to do in the meantime?  Well, I suppose you could look at the ingredient list (from their website). 

Inositol and ginko are used in other mood research ; but vanadium, nickel?  -- I doubt there’s any experience with these, and the concentrations are not shown.

Still wondering if this is safe to take in pregnancy?  No one has any idea, I think you’d have to conclude. 

However, to be fair, it is almost impossible to say "this medication is safe in pregnancy", for any medication on the market.  You just need so many exposures to be able to say that, as discussed above.  Worse yet, there is not a single medication we routinely use for bipolar disorder that is regarded as even somewhat safe, something that we can turn to in the course of a pregnancy when a powerful medication approach is clearly required to maintain the mother's safety (and thus her child's safety as well). In other words, our lack of knowledge is widespread: it goes well beyond the True Hope compound.

Dr. Phelps



Published January, 2009