Notice type: 3rd Party Publications
Problem Or Issue:
ACE inhibitors are a class of medicinal products authorised in Ireland for the treatment of hypertension. ACE inhibitors currently approved as medicines in Ireland include captopril (Capoten), enalapril (Innovace), lisinopril (Zestril), perindopril (Coversyl), ramipril (Tritace), quinapril (Accupro), benzapril (Cibacen), cilazapril (Vascace) and trandolapril (Odrik).
There are also a growing number of generic ACE inhibitors authorised and marketed in Ireland. Prolonged exposure to ACE inhibitors in pregnancy is associated with human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia), with current prescribing information referring to the risks associated with relevant, specific products.
Following publication of a study in the New England Journal of Medicine in June 20061 which showed that children born to women treated with ACE inhibitors during the first trimester of pregnancy appeared to have an increased risk of malformations of the cardiovascular and central nervous systems compared with infants whose mothers didn't take these medicines, the IMB would like to take this opportunity to highlight some of the key prescribing information regarding the use of ACE inhibitors in pregnancy:
- ACE inhibitors are either contraindicated or are not recommended in the first trimester of pregnancy.
- When a pregnancy is planned, a switch to alternative treatment should be initiated as soon as possible.
- When pregnancy is detected, a switch to alternative treatment should be initiated as soon as possible.
- ACE inhibitors are contraindicated in the second and third trimesters of pregnancy.
- ACE inhibitors should not be used in lactating women.
Further evaluation of the above-mentioned study, together with a review of information from other sources (e.g. birth registries), is currently being carried out at a European level. Any further advice/ recommendations arising from this review will be communicated when available.
Finally the IMB would like to take this opportunity to remind healthcare professionals that any suspected adverse reactions should be reported to the IMB in the usual way.
A downloadable version of the ADR report form is available from the HPRA’s website (www.hpra.ie).
Downloaded forms may be completed and sent by freepost to the HPRA.
Envelopes should be marked
Health Products Regulatory Authority,
The Earlsfort Centre,
Alternatively, completed forms may be submitted by fax (01- 6762517).
Post-paid report cards are also available from the Pharmacovigilance Unit at the HPRA (01- 6764971)
1- Cooper WO, et al. N Engl J Med. 2006 Jun 8;354(23):2443-51.