Drugs Xagena
Ace ( angiotensin converting enzyme ) inhibitors and sartans ( also called angiotensin II receptor antagonists ) are licensed for various indications, including hypertension, and may
be particularly suitable for young patients with high blood pressure ( but not those of black ethnic origin ) and those with some comorbidities such as diabetic nephropathy.
Angiotensin II is essential for normal kidney development, and use of Ace inhibitors and angiotensin II receptor antagonists in late pregnancy has been associated with renal dysfunction, oligohydramnios, neonatal anuria, and other congenital anomalies such as skull ossification defects. However, data have also suggested an increased risk of congenital anomaly after exposure limited to the first trimester of pregnancy.
A US cohort study that used Medicaid data from Tennessee noted an increased risk of congenital anomalies with Ace inhibitors, particularly anomalies of the cardiovascular system and CNS.
On the basis of 8 cases ( all major anomalies ) among 209 infants exposed to ACE inhibitors in the first trimester, the adjusted risk ratios for congenital anomalies was 2.71, compared with infants who had no exposure to antihypertensive medicines in the first trimester.
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Because maternal diabetes is independently associated with an increased risk of congenital anomaly, the researchers attempted to exclude mothers with known diabetes.
Although the study has some limitations, such as a small number of events, it raises substantial concern about possible teratogenicity with Ace inhibitors in the first trimester of pregnancy.
There are fewer data for the risks with angiotensin II receptor antagonists, although there are case reports of congenital anomaly after exposure to these agents during the second and third trimesters. urthermore, there are no data to exclude a possible risk similar to that noted for ACE inhibitors in the first trimester.
Source: MHRA Drug Safety Update, 2007
XagenaMedicine_2007
