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Health
Canada Reminds Women Not to Use ACE Inhibitors
During Pregnancy
June
29, 2006
Health Canada
is advising women not to use blood pressure medication
known as ACE (angiotensin-converting enzyme) inhibitors
during pregnancy because of the risk of birth
defects. These drugs are used alone or with other
medicines to treat high blood pressure in adults.
A recent study in the New England
Journal of Medicine suggests that ACE inhibitors
may be associated with increased risk of birth
defects when used in the first three months of
pregnancy.
There are many Health Canada-approved
drugs to treat high blood pressure that do not
contain ACE inhibitors. Women with high blood
pressure who are pregnant, or who plan to become
pregnant, should discuss the use of an appropriate
blood pressure drug with their physician.
All ACE inhibitors approved by Health
Canada already include warnings in the labelling
information against use of these products during
pregnancy. Even before the study, it was known
that taking ACE inhibitors during the last six
months of pregnancy can harm an unborn child.
ACE inhibitors include:
Quinapril HCI (sold under the brand
name Accupril)
Ramipril (sold under the brand name Altace)
Captopril (sold under the brand names Captopril,
Apo-Capto, Capoten, Gen-Captopril, Novo-Captopril,
Nu-Capto, PMS-Captopril, Dom-Captopril,Med Captopril,
Ratio-Captopril, Captopril Tablets by Pharmel
Inc., Captopril Tablets by Pro Doc Limited, Captopril
Tablets by Zymcan Pharmaceuticals Inc.)
Perindopril Erbumine and Perindopril Arginine
(sold under the brand name Coversyl)
Cilazapril Monohydrate (sold under the brand names
Inhibace and Novo-Cilazapril)
Benazepril HCI (sold under the brand names Lotensin
and Apo-Benazepril)
Trandolapril (sold under the brand name Mavik)
Fosinopril Sodium (sold under the brand names
Monopril, Gen-Fosinopril, Riva-Fosinopril, Novo-Fosinopril,
PMS-Fosinopril and Ratio-Fosinopril)
Lisinopril (sold under the brand names Prinivil,
Zestril and Apo-Lisinopril)
Enalapril Maleate (sold under the brand names
Vasotec, Apo-Enalapril and Novo-Enapril)
Enalaprilat (sold under the brand name Vasotec
I.V.)
Drugs containing ACE inhibitors
include:
Quinapril HCI - Hydrochlorothiazide
(sold under the brand name Accuretic)
Perindopril Erbumine - Indapamide (sold under
the brand names Preterax and Coversyl Plus)
Cilazapril Monohydrate - Hydrochlorothiazide (sold
under the brand name Inhibace Plus)
Lisinopril - Hydrochlorothiazide (sold under the
brand names Zestoretic and Prinzide
Enalapril Maleate - Hydrochlorothiazide (sold
under the brand name Vaseretic)
Trandolapril - Verapamil Hydrochloride (sold under
the brand name Tarka)
Health Canada recommends that:
Women who are pregnant should not
take any of the above drugs.
Women who are taking any of the above drugs should
tell their doctors if they are planning to become
pregnant.
Women who are taking any of the above drugs and
are pregnant should contact their physician for
advice.
In light of the study, Health Canada will send
letters by the end of June 2006 to all manufacturers
of ACE inhibitors to ensure standardized wording
on all product labels.
Consumers requiring more information
about this advisory can contact the Health Canada
public inquiries line at (613) 957-2991, or toll
free at 1-866-225-0709.
To report a suspected adverse reaction,
please contact the Canadian Adverse Drug Reaction
Monitoring Program (CADRMP) of Health Canada:
Telephone: 1-866-234-2345 Facsimile:
1-866-678-6789
CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture,
AL 0701C
Ottawa, Ontario K1A 0K9
Email: cadrmp@hc-sc.gc.ca
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