Karthikeyan V.J.,City Hospital |
Ferner R.E.,City Hospital |
Ferner R.E.,West Midlands Center for Adverse Drug Reactions |
Baghdadi S.,City Hospital |
And 3 more authors.
Journal of Hypertension | Year: 2011
Background: Both angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin receptor antagonists (ARBs) have been reported to be associated with an excess of congenital abnormalities in infants born to women who took these drugs in pregnancy. Methods: To investigate this possible association further, we have examined the outcome in 91 pregnancies in which the mother took either an ACE-I (n = 71) or an ARB (n = 20) in early pregnancy. We also examined the United Kingdom adverse drug reaction reporting system to assess the total number of reported associations of ACE-I or ARB use in pregnancy and congenital anomalies reported. Results: Eight (8.8%) of the pregnancies led to an infant with a developmental anomaly, but all save one of these (craniosynostosis with tower skull) anomalies were considered to be relatively minor. The adverse drug reaction reporting system revealed a total of 43 reported defects in women taking an ACE-I and 12 in women taking an ARB. Conclusion: We have not found any convincing excess of congenital anomalies in women taking angiotensin-blocking drugs in early pregnancy. However, this does not exclude the possibility that ACE-I or ARB use in pregnancy might lead to adverse obstetrical outcomes. Until this matter is settled, we support recommendations that these drugs should not be used in pregnancy or in women who are likely to become pregnant. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Cox A.R.,University of Birmingham |
Cox A.R.,West Midlands Center for Adverse Drug Reactions |
Butt T.F.,Broomfield Hospital
Drug Safety | Year: 2012
Communications about the safety of medicines are complex and generally poorly performed. Discussions may not be initiated by healthcare professionals and the lack of a 'common language' to express risk can cause confusion. In the event of a serious adverse drug reaction, prior failures in communication can cause difficulties, and patients may fail to receive adequate information about the nature of their experience. How to communicate openly with patients in order to minimize distrust and maximize future benefits from medicines requires exploration. © 2012 Springer International Publishing AG. All rights reserved.
PubMed | West Midlands Center for Adverse Drug Reactions
Type: Journal Article | Journal: Drug safety | Year: 2011
Biochemical monitoring of patients treated with antihypertensive therapy is recommended in order to identify potential adverse reactions to treatment. We aimed to review the literature investigating the nature of biochemical monitoring in adults treated in primary care with antihypertensive drugs. Specifically, we wished to establish (i) the proportion of patients with biochemical baseline testing prior to the initiation of antihypertensive therapy; (ii) the proportion of patients with biochemical monitoring after initiation of antihypertensive therapy; (iii) the patient characteristics associated with biochemical monitoring; (iv) the frequency of biochemical monitoring after the initiation of antihypertensive therapy; and (v) the relationship, if any, between biochemical monitoring and adverse patient outcomes. We searched MEDLINE, EMBASE and Google Scholar from 1948 to 31 December 2010 using a combination of text words and search terms. Retrospective and prospective cohort studies, cross-sectional studies, randomized controlled trials or quasi-randomized controlled trials, and audits of current clinical practice were included. Clinical trials, case reports and case series were excluded. Studies were included if they provided data on the proportion of patients treated with antihypertensive therapy in primary care who had any biochemical monitoring before or after the initiation of therapy. In total, 15 studies were included in our review, which used a wide variety of definitions of monitoring prior to and after the initiation of antihypertensive therapy. From 17% to 81% of patients treated with antihypertensive drugs had a baseline biochemical test and from 20% to 79% had any follow-up monitoring. In only 7 of the 12 studies that examined follow-up monitoring did more than half of the patients have any monitoring. Overall, this systematic review provides evidence that monitoring as recommended by published guidelines is not commonly undertaken. Only two studies were identified that examined patients with both baseline testing and follow-up monitoring. Omission of one or the other limits the ability to analyse the effect of treatment on electrolyte concentrations or renal function. There is limited research on the patient factors associated with monitoring and further work is required to determine the impact of monitoring on adverse patient outcomes. Important barriers to effective monitoring exist and this review emphasizes that these have not yet been overcome.