Health Canada reminds women not to use ACE inhibitors during pregnancy

Advisory
2006-52
June 29, 2006
For immediate release

OTTAWA - Health Canada is advising women not to use blood pressure medication known as ACE (angiotensin-converting enzyme) inhibitors during pregnancy due to 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 by one of the following methods:

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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Media Inquiries:
Christopher Williams
Health Canada
(613) 946-4250

Public Inquiries:
(613) 957-2991
1-866 225-0709