A question we often receive is “are medications during pregnancy safe?” So many women are faced with the decision of to continue medications during pregnancy compromising often their well-being for the promise of protecting this growing miracle within. Antacids and Tylenols are the mainstay of the home pharmacy. But what to do if a spoonful of sugar doesn’t cure the ailment?
A federal task force is trying to begin investigations to provide clarity to expectant parents and practitioners alike. The National Institutes of Health (NIH) is studying why it is so difficult to obtain reliable answers on whether a medication is “safe” or potentially harmful.
Very few drugs (other than those mentioned above) have been approved as safe and effective in pregnancy. Most medications approved for safety in pregnancy are those for anticipated conditions of pregnancy. In fact, most medications given to pregnant women, from the benign antacids to daily medications for conditions like epilepsy, are considered “off-label.” It means that these medications were not necessarily FDA-approved for the medical conditions but afford great benefit. (It may be surprising to some how many medications are used today regularly and are considered “off-label”)
There are dynamic changes in pregnancy that may make standard dosing more or less effective dependent upon how the medication is distributed in the body. Little research exists in looking at the shifts in absorption of medications and the dynamics during the pregnancy and how these shifts can even occur during the three trimesters of pregnancy itself.
The pharmaceutical industry has avoided clear research on pregnant women. History of medications like thalidomine will always remain as a darkened remembrance of medications that have provocative and negative effects on the fetus. Regulations, too, have discouraged research on pregnant women and most of the data we have is based on animal studies. Pregnant women are considered a vulnerable population.
What remains for patient and practitioner alike is essentially risk management. Does the medication afford more benefit to the maternal-fetal unit or does its absence present more risk?
These are discussions we have daily. What always must be kept in mind is that healthy Mom’s are needed to secure the well-being of the passenger within.
If you have questions on what medications are safe, please contact us.