This article reports recent research results that indicate that the use of popular high blood pressure drugs called ACE inhibitors may, during the first trimester of pregnancy, increase the rate of birth defects from 2.6 per 100 to 7.1 per 100. Although ACE inhibitors have been used for 25 years, the potential risk to human fetuses during the first third of pregnancy had not been explicitly studied.
The article would have been improved if it had included the fact that there may also be risks associated with not using ACE inhibitors for some women, such as those with congestive heart failure or diabetes.
Overall, this story was very well written and reported.
There was no cost comparison for ACE inhibitors and the other medications that might be used in the management of hypertension.
However, since the point of the story was to point out risks, not to promote further use, costs are less of an issue in this story.
There was no quanitification of possible benefits to the mother for using this drug during the first trimester of pregnancy. In some women the risks of taking the drug may be less than the risk of undertreatment.
The harms to the fetus of treating a mother with an ACE inhibitor during the first trimester of pregnancy are plainly mentioned. However the risks of NOT using ACE inhibitors in some women (congestive heart failure, diabetes) are not mentioned. This study was not done in a high risk group and the risks of undertreatment may be greater in some populations. So, for example, women with diabetes and renal dysfunction or those with congestive heart failure would have gotten an incomplete picture from the article.
The article referred to the original retrospective study and where it could be found (New England Journal of Medicine).
This article does not appear to disease monger. Although it does mention that these drugs ‘nearly tripled’ the rate of birth defects, it also attempted to lay out the numbers for what this really meant. But it botched the percentages. The story presents the rate of birth defects for women not taking blood pressure medication as 2.6%, though the data in the New England Journal of Medicine reported that there were 4 out of 202 infants born with birth defects in this group – which is 1.98%. The story mentioned that the rate of birth defects for those who had taken ACE inhibitors during the first trimester of pregnancy was 7.1%, though the journal article reported that there were 18 out of 209 in this group or a birth defect rate of 8.6%.
The article did not note that the data reported on the rate of birth defects after ACE inhibitor use during the first trimester only.
The sources of information appear to be the journal article, an author of the study and spokespersons from the FDA and its Center for Drug Evaluation and Research.
The article included a list of other medications that may be used to to lower blood pressure. However these suffer from the same lack of clinical testing of their safety for use in pregnant women. The story discussed the impact of pregnancy on blood pressure – lowering it for some women and raising it in others.
It is clear from the story that ACE inhibitors are a class of drugs available since the early 1980s; they are commonly prescribed.
It is clear from the story that ACE inhibitors have been used by pregnant women, and that “The number of women taking them early in pregnancy is unknown but probably is small, the study suggests.”
There is no evidence that this story relied on a news release.